Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-27 @ 9:42 AM
Study NCT ID:
NCT01355159
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2011-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mwalker@ohri.ca', 'phone': '6137378899', 'title': 'Dr. Mark Walker', 'phoneExt': '76655', 'organization': 'Ottawa Hospital Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The diagnosis of PE is complex due to its heterogenous aetiology. The criteria for PE have remained consistent with NICE guidelines, but there have been revisions in other settings. Therefore additional women in the study might have had PE.'}}, 'adverseEventsModule': {'description': 'One participant (in the Folic Acid group) withdrew consent on the same day of randomization; participants is excluded from being considered "at risk" for AE/SAEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid', 'otherNumAtRisk': 1227, 'otherNumAffected': 961, 'seriousNumAtRisk': 1227, 'seriousNumAffected': 227}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.', 'otherNumAtRisk': 1236, 'otherNumAffected': 968, 'seriousNumAtRisk': 1236, 'seriousNumAffected': 195}], 'otherEvents': [{'term': 'Other AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 961}, {'groupId': 'EG001', 'numAtRisk': 1236, 'numAffected': 968}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Prematurity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 1236, 'numAffected': 20}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 1236, 'numAffected': 25}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 167}, {'groupId': 'EG001', 'numAtRisk': 1236, 'numAffected': 150}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Preeclampsia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1144', 'groupId': 'OG000'}, {'value': '1157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.34', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery)', 'description': "PE is defined as diastolic blood pressure ≥90 mmHg on two occasions ≥4 hours apart and proteinuria developed in women greater than 20+0 weeks of gestation. Proteinuria is defined as: urinary protein ≥300mg in 24 hour urine collection OR in the absence of 24 hour collection, ≥2+ dipstick proteinuria, OR random protein-creatinine ratio ≥30mg protein/mmol.\n\nOR HELLP (Haemolysis, Elevated, Liver Enzymes, Low Platelets) syndrome defined as: Haemolysis (characteristic peripheral blood smear), Serum LDH ≥ 600U/L, Serum AST ≥ 70U/L, and Platelet count \\<100 x109/L\n\nOR Superimposed pre-eclampsia, defined as history of pre-existing hypertension (diagnosed pre-pregnancy or before 20+0 weeks' gestation) with new proteinuria.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1144', 'groupId': 'OG000'}, {'value': '1157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery)', 'description': 'According to the World Health Organization, "A maternal death is defined as the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed study and were analyzed for primary outcome'}, {'type': 'SECONDARY', 'title': 'Spontaneous Abortion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1172', 'groupId': 'OG000'}, {'value': '1180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.74', 'ciUpperLimit': '2.28', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from randomization until 20+0 weeks of gestation', 'description': 'Spontaneous abortion or miscarriage defined as death of a fetus \\<500g or \\<20 weeks of gestation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome.'}, {'type': 'SECONDARY', 'title': 'Placenta Abruption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1169', 'groupId': 'OG000'}, {'value': '1179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.31', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until delivery', 'description': 'Placental abruption (abruptio placentae) is the premature detachment of a normally positioned placenta from the wall of the uterus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome.'}, {'type': 'SECONDARY', 'title': 'Premature Rupture of Membranes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1169', 'groupId': 'OG000'}, {'value': '1180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.15', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Participants will be followed from randomization (8-16 weeks' completed gestation) until the onset of labor", 'description': 'Rupture of the membranes (rupture of the amniotic sac) before the onset of labor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preterm Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1150', 'groupId': 'OG000'}, {'value': '1164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '297', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.13', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from 20+0 weeks to 36+6 weeks of gestation', 'description': 'Birth that occur earlier than 37+0 weeks of gestational age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome.'}, {'type': 'SECONDARY', 'title': 'HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1144', 'groupId': 'OG000'}, {'value': '1156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.37', 'ciUpperLimit': '3.96', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until delivery', 'description': 'Haemolysis (characteristic peripheral blood smear), Serum LDH \\>=600U/L, Serum AST \\>=70U/L, Platelet count \\<100 x109/L', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome.'}, {'type': 'SECONDARY', 'title': 'Severe Preeclampsia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1144', 'groupId': 'OG000'}, {'value': '1156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.81', 'ciUpperLimit': '2.84', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until delivery.', 'description': 'Severe PE: Defined as PE with convulsion or HELLP or delivery \\<34 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome.'}, {'type': 'SECONDARY', 'title': 'Antenatal Inpatient Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '1.63', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': "Participants will be followed from date of randomization (8-16 weeks' completed gestation) until admission for delivery", 'description': 'Length of inpatient stay before admission for delivery in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome.'}, {'type': 'SECONDARY', 'title': 'Stillbirth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1364', 'groupId': 'OG000'}, {'value': '1374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.19', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation up to delivery.', 'description': 'Fetal death defined as death of fetus of at least 500 grams birth weight or, if birth weight is unavailable, a gestational age of at least 20+0 weeks of gestation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome.'}, {'type': 'SECONDARY', 'title': 'Intrauterine Growth Restriction (<3rd Percentile)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1347', 'groupId': 'OG000'}, {'value': '1348', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.39', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until delivery', 'description': 'Intrauterine growth restriction is defined as a birth weight less than the 3rd percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Intrauterine Growth Restriction (<10th Percentile)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1347', 'groupId': 'OG000'}, {'value': '1348', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.30', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until delivery', 'description': 'Intrauterine growth restriction is defined as a birth weight less than the 10th percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Neonatal Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1343', 'groupId': 'OG000'}, {'value': '1347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.31', 'ciUpperLimit': '2.44', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from birth until 28 days of life', 'description': 'Neonatal death defined as death of a baby that occurred during first 28 days of life.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Perinatal Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1364', 'groupId': 'OG000'}, {'value': '1374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.05', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until 28 days of life.', 'description': 'The perinatal mortality is defined as the number of deaths (fetal deaths and neonatal deaths) of babies ≥ 500 grams birth weight or, if birth weight is unavailable, a gestational age ≥ 20+0 weeks, up to 28 completed days after birth.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Retinopathy of Prematurity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'OG000'}, {'value': '1347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.54', 'ciUpperLimit': '2.66', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Infants born to the participant will be followed for the duration of hospital stay, or up to 6 weeks', 'description': 'Retinopathy of prematurity a retinopathy typically occurring in premature infants treated with high concentrations of oxygen, characterized by vascular dilatation, proliferation, tortuosity, edema, retinal detachment, and fibrous tissue behind the lens confirmed by retinal examination according to an International Committee for the Classification of Retinopathy of Prematurity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Early Onset Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'OG000'}, {'value': '1347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.09', 'ciUpperLimit': '1.23', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Infants born to the participants will be followed first 48 hours of life.', 'description': 'Within first 48hr of life, confirmed by positive blood or cerebrospinal fluid cultures', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Necrotising Enterocolitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1343', 'groupId': 'OG000'}, {'value': '1347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.04', 'ciLowerLimit': '0.49', 'ciUpperLimit': '8.57', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Infants borm to the participants will be followed for the duration of hospital stay, or up to 6 weeks.', 'description': "Necrotizing enterocolitis (NEC) according to modified Bell's criteria stage 2 or higher (grossly bloody stool, plus absent bowel sounds with or without abdominal tenderness and radiographic findings such as intestinal dilation, ileus, pneumatosis intestinalis), excluding isolated spontaneous intestinal perforations.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Intraventricular Hemorrhage (IVH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1343', 'groupId': 'OG000'}, {'value': '1347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.47', 'ciUpperLimit': '2.00', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time Frame: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks', 'description': '* IVH Grade 1(Blood in germinal matrix)\n* IVH Grade 2 (Blood in germinal matrix and extending into the ventricles)\n* IVH Grade 3 (Ventricular enlargement)\n* IVH Grade 4 (Intraparenchymal lesion)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1346', 'groupId': 'OG000'}, {'value': '1348', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '0.97', 'ciUpperLimit': '2.66', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks.', 'description': 'Ventilatory support after initial resuscitation, with/without intubation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Need for Oxygen at 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1220', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.37', 'ciLowerLimit': '0.61', 'ciUpperLimit': '9.14', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Infants to the participants will be followed for 28 days after birth.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Composite Severe Adverse Fetal/Neonatal Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1348', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.80', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Outcomes included in the composite outcome were measured for each of their respective time frames, up to 6-weeks after birth', 'description': 'Composite outcome included any of retinopathy of prematurity, periventricular leukomacia, early onset sepsis, necrotizing enterocolitis, intraventricular haemorrhage, ventilation. Need for O2at 28 days, NICU admission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': "Length of Stay in 'High Level' Neonatal Care Unit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '27', 'groupId': 'OG000'}, {'value': '17', 'spread': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '046', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.60', 'ciLowerLimit': '-5.84', 'ciUpperLimit': '2.64', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Neonatal Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1343', 'groupId': 'OG000'}, {'value': '1347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.31', 'ciUpperLimit': '2.44', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Infants to the participants will be followed for 28 days after birth.', 'description': 'Neonatal death defined as death of the infant occurred before 28 days of life', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Periventricular Leukomalacia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1343', 'groupId': 'OG000'}, {'value': '1347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '0.37', 'ciUpperLimit': '10.92', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Infants to the participants were followed for 28 days after birth.', 'description': 'One of the two outcomes used to measure neonatal morbidity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Neonatal Intensive Care Unit (NICU) Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1346', 'groupId': 'OG000'}, {'value': '1348', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.', 'description': 'This outcome measured whether or not the infant was admitted into the NICU.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1228'}, {'groupId': 'FG001', 'numSubjects': '1236'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1144'}, {'groupId': 'FG001', 'numSubjects': '1157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '79'}]}], 'dropWithdraws': [{'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'No primary outcome data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Spontaneous abortion (<20 weeks)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Early intrauterine fetal death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'High risk pregnant women were recruited in Canada and internationally.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid\n\nFolic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo\n\nPlacebo: Placebo x 4 tablets will be taken daily by oral administration.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '31', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '31', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Maternal age (years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'title': '<20', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '20-29', 'measurements': [{'value': '439', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '886', 'groupId': 'BG002'}]}, {'title': '30-34', 'measurements': [{'value': '411', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '852', 'groupId': 'BG002'}]}, {'title': '>=35', 'measurements': [{'value': '367', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '705', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Maternal Background', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Native/Aboriginal', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '970', 'groupId': 'BG000'}, {'value': '987', 'groupId': 'BG001'}, {'value': '1957', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Latino/Hispanic', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Indian/South Asian', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Declined to answer', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '600', 'groupId': 'BG000'}, {'value': '607', 'groupId': 'BG001'}, {'value': '1207', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Jamaica', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '380', 'groupId': 'BG000'}, {'value': '383', 'groupId': 'BG001'}, {'value': '763', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parity', 'classes': [{'title': '0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '413', 'groupId': 'BG000'}, {'value': '420', 'groupId': 'BG001'}, {'value': '833', 'groupId': 'BG002'}]}]}, {'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '498', 'groupId': 'BG000'}, {'value': '499', 'groupId': 'BG001'}, {'value': '997', 'groupId': 'BG002'}]}]}, {'title': '>=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '316', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '633', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-pregnancy BMI (kg/m2)', 'classes': [{'title': '<18.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': '18.5 to <25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}]}]}, {'title': '25 to <30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '410', 'groupId': 'BG002'}]}]}, {'title': '30 to <35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}]}, {'title': '>=35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '607', 'groupId': 'BG000'}, {'value': '655', 'groupId': 'BG001'}, {'value': '1262', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education level', 'classes': [{'title': 'High school and below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '348', 'groupId': 'BG001'}, {'value': '701', 'groupId': 'BG002'}]}]}, {'title': 'College/University not complete', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}]}, {'title': 'College/University completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '675', 'groupId': 'BG000'}, {'value': '689', 'groupId': 'BG001'}, {'value': '1364', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '3 participants were missing education (1 in the intervention arm and 2 in the placebo arm). Therefore, only 1226 participants in the intervention arm and 1234 participants in the placebo arm had data for this baseline measure.', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age (weeks) at recruitment', 'classes': [{'title': '8-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '386', 'groupId': 'BG000'}, {'value': '433', 'groupId': 'BG001'}, {'value': '819', 'groupId': 'BG002'}]}]}, {'title': '13-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '841', 'groupId': 'BG000'}, {'value': '803', 'groupId': 'BG001'}, {'value': '1644', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking during pregnancy', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1046', 'groupId': 'BG000'}, {'value': '1035', 'groupId': 'BG001'}, {'value': '2081', 'groupId': 'BG002'}]}]}, {'title': 'Quit during pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol during pregnancy', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '977', 'groupId': 'BG000'}, {'value': '955', 'groupId': 'BG001'}, {'value': '1932', 'groupId': 'BG002'}]}]}, {'title': 'Quit during pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Supplementation of FA at randomisation (yes)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '989', 'groupId': 'BG000'}, {'value': '1016', 'groupId': 'BG001'}, {'value': '2005', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Supplementation of high dose FA at randomisation (yes)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '346', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '681', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Aspirin supplementation at randomisation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '358', 'groupId': 'BG000'}, {'value': '340', 'groupId': 'BG001'}, {'value': '698', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Calcium supplementation at randomisation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dietary Folate (µg) (Mean, SD)', 'classes': [{'title': "VIsit 1 (8-16 completed weeks' gestation)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1215', 'groupId': 'BG000'}, {'value': '1225', 'groupId': 'BG001'}, {'value': '2440', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '494', 'spread': '209', 'groupId': 'BG000'}, {'value': '504', 'spread': '222', 'groupId': 'BG001'}, {'value': '499', 'spread': '216', 'groupId': 'BG002'}]}]}, {'title': "Visit 2 (24-26 weeks' completed gestation)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1008', 'groupId': 'BG000'}, {'value': '1023', 'groupId': 'BG001'}, {'value': '2031', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '494', 'spread': '209', 'groupId': 'BG000'}, {'value': '500', 'spread': '213', 'groupId': 'BG001'}, {'value': '497', 'spread': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Dietary folate was measured at both Visit 1 and Visit 2 in the study to capture folate intake from food throughout pregnancy.', 'unitOfMeasure': 'µg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Remaining participants did not return study treatment and so the mean could not be calculated.'}, {'title': 'Visit 2 Compliance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '964', 'groupId': 'BG000'}, {'value': '977', 'groupId': 'BG001'}, {'value': '1941', 'groupId': 'BG002'}]}], 'categories': [{'title': '≤50%', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': '50-75%', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}, {'title': '≥75%', 'measurements': [{'value': '716', 'groupId': 'BG000'}, {'value': '749', 'groupId': 'BG001'}, {'value': '1465', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants completed the Food Frequency Questionnaire at Visit 2 to capture dietary folate during mid-pregnancy.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Calculated on returned study treatment (n=1941). Remaining participants did not return any study treatment and compliance could not be calculated (n=522).'}, {'title': 'History of Pre-eclampsia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '308', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '611', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type 1 Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type 2 Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Twin Pregnancy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '462', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index >=35', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '606', 'groupId': 'BG000'}, {'value': '656', 'groupId': 'BG001'}, {'value': '1262', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prepregnancy Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '34', 'spread': '13', 'groupId': 'BG001'}, {'value': '34', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational age at recruitment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '1236', 'groupId': 'BG001'}, {'value': '2463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '14', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '14', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'One participant (in the Folic Acid group) withdrew consent on the same day of randomization and was excluded completely from the baseline and outcome analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2464}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-22', 'studyFirstSubmitDate': '2011-05-11', 'resultsFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2011-05-16', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-22', 'studyFirstPostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preeclampsia', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery)', 'description': "PE is defined as diastolic blood pressure ≥90 mmHg on two occasions ≥4 hours apart and proteinuria developed in women greater than 20+0 weeks of gestation. Proteinuria is defined as: urinary protein ≥300mg in 24 hour urine collection OR in the absence of 24 hour collection, ≥2+ dipstick proteinuria, OR random protein-creatinine ratio ≥30mg protein/mmol.\n\nOR HELLP (Haemolysis, Elevated, Liver Enzymes, Low Platelets) syndrome defined as: Haemolysis (characteristic peripheral blood smear), Serum LDH ≥ 600U/L, Serum AST ≥ 70U/L, and Platelet count \\<100 x109/L\n\nOR Superimposed pre-eclampsia, defined as history of pre-existing hypertension (diagnosed pre-pregnancy or before 20+0 weeks' gestation) with new proteinuria."}], 'secondaryOutcomes': [{'measure': 'Maternal Death', 'timeFrame': 'Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery)', 'description': 'According to the World Health Organization, "A maternal death is defined as the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.'}, {'measure': 'Spontaneous Abortion', 'timeFrame': 'Participants will be followed from randomization until 20+0 weeks of gestation', 'description': 'Spontaneous abortion or miscarriage defined as death of a fetus \\<500g or \\<20 weeks of gestation'}, {'measure': 'Placenta Abruption', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until delivery', 'description': 'Placental abruption (abruptio placentae) is the premature detachment of a normally positioned placenta from the wall of the uterus.'}, {'measure': 'Premature Rupture of Membranes', 'timeFrame': "Participants will be followed from randomization (8-16 weeks' completed gestation) until the onset of labor", 'description': 'Rupture of the membranes (rupture of the amniotic sac) before the onset of labor.'}, {'measure': 'Preterm Birth', 'timeFrame': 'Participants will be followed from 20+0 weeks to 36+6 weeks of gestation', 'description': 'Birth that occur earlier than 37+0 weeks of gestational age.'}, {'measure': 'HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count)', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until delivery', 'description': 'Haemolysis (characteristic peripheral blood smear), Serum LDH \\>=600U/L, Serum AST \\>=70U/L, Platelet count \\<100 x109/L'}, {'measure': 'Severe Preeclampsia', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until delivery.', 'description': 'Severe PE: Defined as PE with convulsion or HELLP or delivery \\<34 weeks.'}, {'measure': 'Antenatal Inpatient Length of Stay', 'timeFrame': "Participants will be followed from date of randomization (8-16 weeks' completed gestation) until admission for delivery", 'description': 'Length of inpatient stay before admission for delivery in days'}, {'measure': 'Stillbirth', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation up to delivery.', 'description': 'Fetal death defined as death of fetus of at least 500 grams birth weight or, if birth weight is unavailable, a gestational age of at least 20+0 weeks of gestation.'}, {'measure': 'Intrauterine Growth Restriction (<3rd Percentile)', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until delivery', 'description': 'Intrauterine growth restriction is defined as a birth weight less than the 3rd percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard.'}, {'measure': 'Intrauterine Growth Restriction (<10th Percentile)', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until delivery', 'description': 'Intrauterine growth restriction is defined as a birth weight less than the 10th percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard.'}, {'measure': 'Neonatal Death', 'timeFrame': 'Participants will be followed from birth until 28 days of life', 'description': 'Neonatal death defined as death of a baby that occurred during first 28 days of life.'}, {'measure': 'Perinatal Mortality', 'timeFrame': 'Participants will be followed from 20+0 weeks of gestation until 28 days of life.', 'description': 'The perinatal mortality is defined as the number of deaths (fetal deaths and neonatal deaths) of babies ≥ 500 grams birth weight or, if birth weight is unavailable, a gestational age ≥ 20+0 weeks, up to 28 completed days after birth.'}, {'measure': 'Retinopathy of Prematurity', 'timeFrame': 'Infants born to the participant will be followed for the duration of hospital stay, or up to 6 weeks', 'description': 'Retinopathy of prematurity a retinopathy typically occurring in premature infants treated with high concentrations of oxygen, characterized by vascular dilatation, proliferation, tortuosity, edema, retinal detachment, and fibrous tissue behind the lens confirmed by retinal examination according to an International Committee for the Classification of Retinopathy of Prematurity.'}, {'measure': 'Early Onset Sepsis', 'timeFrame': 'Infants born to the participants will be followed first 48 hours of life.', 'description': 'Within first 48hr of life, confirmed by positive blood or cerebrospinal fluid cultures'}, {'measure': 'Necrotising Enterocolitis', 'timeFrame': 'Infants borm to the participants will be followed for the duration of hospital stay, or up to 6 weeks.', 'description': "Necrotizing enterocolitis (NEC) according to modified Bell's criteria stage 2 or higher (grossly bloody stool, plus absent bowel sounds with or without abdominal tenderness and radiographic findings such as intestinal dilation, ileus, pneumatosis intestinalis), excluding isolated spontaneous intestinal perforations."}, {'measure': 'Intraventricular Hemorrhage (IVH)', 'timeFrame': 'Time Frame: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks', 'description': '* IVH Grade 1(Blood in germinal matrix)\n* IVH Grade 2 (Blood in germinal matrix and extending into the ventricles)\n* IVH Grade 3 (Ventricular enlargement)\n* IVH Grade 4 (Intraparenchymal lesion)'}, {'measure': 'Ventilation', 'timeFrame': 'Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks.', 'description': 'Ventilatory support after initial resuscitation, with/without intubation.'}, {'measure': 'Need for Oxygen at 28 Days', 'timeFrame': 'Infants to the participants will be followed for 28 days after birth.'}, {'measure': 'Composite Severe Adverse Fetal/Neonatal Outcome', 'timeFrame': 'Outcomes included in the composite outcome were measured for each of their respective time frames, up to 6-weeks after birth', 'description': 'Composite outcome included any of retinopathy of prematurity, periventricular leukomacia, early onset sepsis, necrotizing enterocolitis, intraventricular haemorrhage, ventilation. Need for O2at 28 days, NICU admission'}, {'measure': "Length of Stay in 'High Level' Neonatal Care Unit", 'timeFrame': 'Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.'}, {'measure': 'Neonatal Death', 'timeFrame': 'Infants to the participants will be followed for 28 days after birth.', 'description': 'Neonatal death defined as death of the infant occurred before 28 days of life'}, {'measure': 'Periventricular Leukomalacia', 'timeFrame': 'Infants to the participants were followed for 28 days after birth.', 'description': 'One of the two outcomes used to measure neonatal morbidity.'}, {'measure': 'Neonatal Intensive Care Unit (NICU) Admission', 'timeFrame': 'Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.', 'description': 'This outcome measured whether or not the infant was admitted into the NICU.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pregnancy', 'Folic Acid supplementation', 'Preeclampsia'], 'conditions': ['Pregnancy Complications', 'Preeclampsia']}, 'referencesModule': {'references': [{'pmid': '37073421', 'type': 'DERIVED', 'citation': 'Muldoon KA, McLean C, El-Chaar D, Corsi DJ, Rybak N, Dagvadorj A, Guo Y, Rennicks White R, Dingwall-Harvey ALJ, Gaudet LM, Walker MC, Wen SW; FACT Collaborating Group. Persisting risk factors for preeclampsia among high-risk pregnancies already using prophylactic aspirin: a multi-country retrospective investigation. J Matern Fetal Neonatal Med. 2023 Dec;36(1):2200879. doi: 10.1080/14767058.2023.2200879.'}, {'pmid': '33851221', 'type': 'DERIVED', 'citation': 'Rose EG, Murphy MSQ, Erwin E, Muldoon KA, Harvey ALJ, Rennicks White R, MacFarlane AJ, Wen SW, Walker MC. Gestational Folate and Folic Acid Intake among Women in Canada at Higher Risk of Pre-Eclampsia. J Nutr. 2021 Jul 1;151(7):1976-1982. doi: 10.1093/jn/nxab063.'}, {'pmid': '32067533', 'type': 'DERIVED', 'citation': 'Corsi DJ, Gaudet LM, El-Chaar D, White RR, Rybak N, Harvey A, Muldoon K, Wen SW, Walker M. Effect of high-dose folic acid supplementation on the prevention of preeclampsia in twin pregnancy. J Matern Fetal Neonatal Med. 2022 Feb;35(3):503-508. doi: 10.1080/14767058.2020.1725882. Epub 2020 Feb 18.'}, {'pmid': '30209050', 'type': 'DERIVED', 'citation': 'Wen SW, White RR, Rybak N, Gaudet LM, Robson S, Hague W, Simms-Stewart D, Carroli G, Smith G, Fraser WD, Wells G, Davidge ST, Kingdom J, Coyle D, Fergusson D, Corsi DJ, Champagne J, Sabri E, Ramsay T, Mol BWJ, Oudijk MA, Walker MC; FACT Collaborating Group. Effect of high dose folic acid supplementation in pregnancy on pre-eclampsia (FACT): double blind, phase III, randomised controlled, international, multicentre trial. BMJ. 2018 Sep 12;362:k3478. doi: 10.1136/bmj.k3478.'}, {'pmid': '24349782', 'type': 'DERIVED', 'citation': 'Wen SW, Champagne J, Rennicks White R, Coyle D, Fraser W, Smith G, Fergusson D, Walker MC. Effect of folic acid supplementation in pregnancy on preeclampsia: the folic acid clinical trial study. J Pregnancy. 2013;2013:294312. doi: 10.1155/2013/294312. Epub 2013 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'To determine the efficacy of high dose folic acid supplementation for prevention of preeclampsia in women with at least one risk factor: pre-existing hypertension, pre-pregnancy diabetes (type 1 or 2), twin pregnancy, preeclampsia in a previous pregnancy, or body mass index ≥35. It was hypothesized that high dose (4.0 mg per day) supplementation starting in early pregnancy and continued throughout the entire pregnancy will lower the incidence of preeclampsia in pregnant women at high risk of developing preeclampsia.', 'detailedDescription': 'Preeclampsia is a complication of pregnancy which affects at least 5% of all pregnancies worldwide and has serious health consequences to these women and their babies. Preeclampsia is hypertension (high blood pressure) in pregnancy with proteinuria. Proteinuria is when protein is found in the urine, and it is a sign that the kidneys are not functioning properly. The only effective treatment for preeclampsia is delivery of the baby. Because delivery may be required before the anticipated date of delivery; preeclampsia is also one of the leading causes of preterm delivery and accounts for 25% of very low birth weight infants. Recent research has also shown that women who have had preeclampsia during pregnancy are more likely to be at risk for future cardiovascular events later in life.\n\nRecently some studies have shown that supplementation with multivitamins containing folic acid is associated with a reduced risk of developing preeclampsia. These findings also suggested that for the prevention of preeclampsia, a high dose of folic acid (much higher than the amount of folate received from food intake or what is usually taken during pregnancy) may be needed.\n\nA randomized controlled trial was conducted in 70 obstetrical centres in 5 countries (Argentina, Australia, Canada, Jamaica, and the UK) to evaluate the effect of high dose folic acid started in early pregnancy on the risk of developing preeclampsia in high-risk women. A sample size of 2464 allowed for 80% power and a 10% loss to follow-up/study withdrawal. Participants received either placebo or four 1.0 mg oral tablets of folic acid.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Capability of subject to comprehend and comply with study requirements\n2. ≥ 18 years of age at time of consent\n3. Subject is taking ≤1.1 mg of folic acid daily at the time of randomization\n4. Live fetus (documented positive fetal heart prior to randomization)\n5. Gestational age between 8+0 and 16+6 weeks of pregnancy (Gestational age (GA) of subjects will be calculated based on the first day of the last menstrual period (LMP) or ultrasound performed before 12+6. If early ultrasound and LMP dates differ by ≤ 7 days, base GA estimate on LMP date; if \\> 7 days, use early \\< 12+6 ultrasound)\n6. Subject plans to give birth in a participating hospital site\n7. Pregnant subjects must fulfill at least one of the following identified risk factors for pre-eclampsia (PE):\n\n * Pre-existing hypertension (documented evidence of diastolic blood pressure ≥ 90 mmHg on two separate occasions or at least 4 hours apart prior to randomization, or use of antihypertensive medication during this pregnancy specifically for the treatment of hypertension prior to randomization)\n * Pre-pregnancy diabetes (documented evidence of Type I or type II DM)\n * Twin pregnancy\n * Documented evidence of history of PE in a previous pregnancy\n * BMI \\> 35 kg/m2 within 3 months prior to this pregnancy and up to randomization of this pregnancy (documented evidence of height and weight to calculate BMI is required)\n\nExclusion Criteria:\n\n1. Known history or presence of any clinically significant disease or condition which would be a contraindication to folic acid supplementation of up to 5 mg daily for the duration of pregnancy\n2. Known major fetal anomaly or fetal demise\n3. History of medical complications, including:\n\n * renal disease with altered renal function,\n * epilepsy,\n * cancer, or\n * use of folic acid antagonists such as valproic acid\n4. Individual who is currently enrolled or has participated in another clinical trial or who received an investigational drug within 3 months of the date of randomization (unless approved by the Trial Coordinating Centre)\n5. Known presence of:\n\n * Alcohol abuse (≥ 2 drinks per day) or alcohol dependence\n * Illicit drug/substance use and/or dependence\n6. Known hypersensitivity to folic acid\n7. Multiple Pregnancy (triplets or more)\n8. Participation in this study in a previous pregnancy'}, 'identificationModule': {'nctId': 'NCT01355159', 'acronym': 'FACT', 'briefTitle': 'High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia-Folic Acid Clinical Trial (FACT)', 'orgStudyIdInfo': {'id': '2009-107'}, 'secondaryIdInfos': [{'id': 'ISRCTN23781770', 'type': 'OTHER', 'domain': 'controlled-trials.com'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Folic Acid 4 mg', 'description': 'Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid', 'interventionNames': ['Drug: Folic Acid 4 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Folic Acid 4 mg', 'type': 'DRUG', 'otherNames': ['Folate'], 'description': 'Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid', 'armGroupLabels': ['Folic Acid 4 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo x 4 tablets will be taken daily by oral administration.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S2000DKR', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Hospital Escuela Eva Perón', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Hospital Provincial', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Hospital Roque Saenz Penia', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Maternidad Martin', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Sanatorio de la Mujer', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Cemic', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Santa Fe', 'country': 'Argentina', 'facility': 'Hospital Cullen', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'city': 'Santa Fe', 'country': 'Argentina', 'facility': 'Hosptial Iturraspe', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': '2750', 'city': 'Penrith', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Nepean', 'geoPoint': {'lat': -33.75, 'lon': 150.7}}, {'zip': '4814', 'city': 'Douglas', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Townsville', 'geoPoint': {'lat': -19.32394, 'lon': 146.75234}}, {'zip': '4305', 'city': 'Ipswich', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Ipswich', 'geoPoint': {'lat': -27.62343, 'lon': 152.76067}}, {'zip': 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