Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-23 @ 9:21 PM
Study NCT ID:
NCT03944512
Status:
TERMINATED
Last Update Posted:
2025-12-23
First Post:
2019-05-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pravastatin to Prevent Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017035', 'term': 'Pravastatin'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maged.costantine@osumc.edu', 'phone': '614-293-9036', 'title': 'Maged M. Costantine, MD', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates.', 'description': 'Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.', 'eventGroups': [{'id': 'EG000', 'title': '20mg Pravastatin - Mother', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 12, 'seriousNumAtRisk': 25, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo - Mother', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 25, 'otherNumAffected': 11, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 2, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety/nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza-like Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fetal Demise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Termination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankyloglossia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suspected fetal abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypospadias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor glycemic control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor glycemic control and hyperemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor glycemic control and severe hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeding difficulty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bowel enterotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoxic ischemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchopulmonary dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension / preeclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Maternal Death (Breast Cancer)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With Composite of Preeclampsia, Fetal Loss and Maternal Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.19', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours postpartum', 'description': 'Proportion of participants demonstrating a composite of preeclampsia, fetal loss, or maternal death.\n\n1. Baseline Normotensive: a) Severe hypertension (HTN) or b) Mild HTN w/ any of the following: i.) New-onset proteinuria or doubling in protein w/ baseline proteinuria ii.) Thrombocytopenia iii.) Progressive renal insufficiency iv). Impaired liver function v.) Pulmonary edema vi.) New-onset \\& persistent cerebral or visual symptoms\n2. Baseline chronic HTN: any of the following a)Severe HTN b) New onset proteinuria or doubling in protein from baseline proteinuria c)Thrombocytopenia d) Progressive renal insufficiency e) Impaired liver function f) Pulmonary edema g) New-onset \\& persistent cerebral or visual symptoms.\n3. HELLP a) Hemolysis AND b)Thrombocytopenia AND c) AST/ALT ≥ 70 IU/L\n4. Atypical HELLP an occurrence of 2 of the 3: a) Hemolysis, b)Thrombocytopenia, OR c) AST/ALT ≥ 70 IU/L\n5. Eclampsia\n6. Competing outcomes: maternal death before delivery or fetal loss \\< 20wks, 0 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Preeclampsia With Severe Features', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.07', 'ciUpperLimit': '2.67', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours postpartum', 'description': 'Preeclampsia with severe features as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnostic criteria (i.e., severe hypertension, thrombocytopenia, impaired liver function, progressive renal insufficiency, pulmonary edema, new-onset and persistent cerebral or visual symptoms)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Gestational Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.00', 'ciLowerLimit': '0.32', 'ciUpperLimit': '77.16', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours postpartum', 'description': 'Defined as new onset hypertension in the absence of accompanying proteinuria or other features of preeclampsia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Pregnancy Associated Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.22', 'ciUpperLimit': '1.43', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours postpartum', 'description': 'Defined as gestational hypertension or preeclampsia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Postpartum Preeclampsia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in the placebo group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours postpartum through 6 weeks post partum', 'description': 'Preeclampsia that occurs more than 48 hours after birth', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Gestational Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '0.58', 'ciUpperLimit': '5.24', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At any time during pregnancy through delivery (up to approximately 30 weeks)', 'description': 'Gestational diabetes mellitus', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Adherence to Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}], 'classes': [{'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to delivery (up to approximately 30 weeks)', 'description': 'Adherence to the medication regimen for the study (daily pill) defined as the time from randomization to delivery. The earliest gestational age at randomization is 12 weeks and most women deliver by 42 weeks gestation which is why the time frame is up to a maximum of approximately 30 weeks. Given the earlier gestational age of delivery in this cohort, the time period is shorter than 30 weeks.', 'unitOfMeasure': 'percentage of compliance', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Severe Maternal Morbidity Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in the pravastatin and placebo groups'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization through 6 weeks postpartum', 'description': 'A composite of severe maternal morbidity of either maternal death, eclampsia, HELLP syndrome, cerebral vascular accident, heart failure, myocardial infarction, acute respiratory distress syndrome requiring mechanical ventilation, disseminated intravascular coagulopathy, pulmonary edema, renal failure, liver rupture, or placental abruption', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Maternal Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '44'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Delivery admission through discharge from the hospital (a median of 3 days)', 'description': 'Length of maternal hospital stay for the delivery admission (admission to discharge)', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Adverse Events of Special Interest (AESI) or Serious AESI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in the placebo group'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization through 48 hours postpartum', 'description': 'Adverse events of Special Interest (AESI) including myalgia and muscle weakness, and serious AESI include maternal myositis, myopathy, rhabdomyolysis, or serious liver injury', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gestational Age at Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '39.9'}, {'value': '37.0', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '39.4'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Delivery', 'description': 'Gestational age at the time of delivery', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For twin gestation, the worst outcome for the twin pair is analyzed/reported.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Preterm Birth < 37 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.23', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Delivery before 37 weeks', 'description': 'Preterm birth before 37 weeks gestation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For twin gestation, the worst outcome for the twin pair is analyzed/reported.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Indicated Preterm Birth < 37 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.57', 'ciUpperLimit': '2.91', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Delivery before 37 weeks', 'description': 'Indicated preterm birth less than 37 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For twin gestation, the worst outcome for the twin pair is analyzed/reported.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Preterm Birth < 34 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.19', 'ciUpperLimit': '1.71', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Delivery before 34 weeks', 'description': 'Preterm birth before 34 weeks gestation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For twin gestation, the worst outcome for the twin pair is analyzed/reported.'}, {'type': 'SECONDARY', 'title': 'Proportion of Fetal or Neonatal Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.02', 'ciUpperLimit': '5.35', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'randomization (mother) through 28 days of life (neonate)', 'description': 'Death of the fetus or neonate', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For twin gestation, the worst outcome for the twin pair is analyzed/reported.'}, {'type': 'SECONDARY', 'title': 'Birth Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '2626', 'spread': '668', 'groupId': 'OG000'}, {'value': '2543', 'spread': '884', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Birth', 'description': 'Birth weight', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported.'}, {'type': 'SECONDARY', 'title': 'Proportion of Small for Gestational Age < 5th Percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.24', 'ciUpperLimit': '13.59', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth', 'description': 'Birthweight \\< 5th percentile', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported.'}, {'type': 'SECONDARY', 'title': 'Proportion of Small for Gestational Age < 10th Percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.42', 'ciUpperLimit': '2.73', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth', 'description': 'Birthweight \\< 10th percentile', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported.'}, {'type': 'SECONDARY', 'title': 'Proportion of NICU/Intermediate Nursery Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.58', 'ciUpperLimit': '2.18', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Admission to the neonatal intensive care unit (NICU) or intermediate nursery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'NICU/Intermediate Nursery Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '83'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '220'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Length of stay in the neonatal intensive care unit (NICU) and/or intermediate nursery.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Neonates admitted to the NICU. For twin gestation, the worst outcome for the twin pair is analyzed/reported.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates Needing Mechanical Ventilation or Continuous Positive Airway Pressure (CPAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '0.52', 'ciUpperLimit': '4.51', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Mechanical ventilation or CPAP support', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 2 placebo participants.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates Needing Oxygen Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.42', 'ciUpperLimit': '5.00', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Provision of oxygen support for the neonate', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 2 placebo participants.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates With Respiratory Distress Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.11', 'ciUpperLimit': '2.95', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Respiratory distress syndrome (RDS), defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis), with an oxygen requirement and confirmed by a chest x-ray', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates With Bronchopulmonary Dysplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in both groups.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days of life and 36 weeks corrected gestational age', 'description': 'Bronchopulmonary dysplasia (BPD), defined as oxygen requirement at 28 days of life and at 36 weeks corrected gestational age', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates With Necrotizing Enterocolitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in the pravastatin group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Necrotizing enterocolitis (NEC), defined as modified Bell Stage 2 (clinical signs and symptoms with pneumatosis intestinalis on radiographs) or Stage 3 (advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates With Intraventricular Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in both groups.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Intraventricular hemorrhage (IVH) grade III-IV', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates With Periventricular Leukomalacia (PVL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in both groups.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Periventricular leukomalacia (PVL), diagnosed by neuroimaging', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates Experiencing Early Onset Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in both groups.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to 72 hours from birth', 'description': 'Neonatal sepsis (within first 72 hours after birth). The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebral spinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal radiograph confirming infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates Experiencing Late Onset Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in pravastatin group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Neonatal sepsis (\\>72 hours after birth). The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebral spinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal radiograph confirming infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates With Retinopathy of Prematurity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in both groups.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Retinopathy of prematurity (ROP) stage III or higher', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates With Composite Neonatal Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.17', 'ciUpperLimit': '2.04', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Fetal or neonatal death, RDS, Grade III-IV IVH, PVL, Stage 2 or 3 NEC, BPD, Stage III or higher ROP, or early onset sepsis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates Experiencing Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in both groups.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Neonatal seizure activity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Proportion of Neonates With a Congenital Anomaly / Birth Defect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.03', 'ciUpperLimit': '31.79', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization through delivery (up to approximately 30 weeks)', 'description': 'Congenital anomaly or birth defect excluding any conditions that must have been present before randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'Neonatal Auditory Brain Stem Response (ABR)/Otoacoustic Emissions (OAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in both groups.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Neonatal auditory brain stem response (ABR)/Otoacoustic Emissions (OAE) test results of fail/refer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liveborn neonates only. For twin gestation, the worst outcome for the twin pair is analyzed/reported. Data missing for 1 pravastatin and 1 placebo participant.'}, {'type': 'SECONDARY', 'title': 'BMI for Age at 24 Corrected Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '98.7'}, {'value': '50.6', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '96.8'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '24 months of age', 'description': 'Body mass index for age percentile at 24 corrected months using Centers for Disease Control (CDC) pediatric growth charts', 'unitOfMeasure': 'percentile', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cognitive Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '93.8', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '87.9', 'spread': '14.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 months of age', 'description': 'Bayley Certified Scales of Infant Development III Edition standard score for cognitive abilities at 24 months of age.\n\nComposite standard scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160.\n\nHigher scores mean better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Motor Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '90.5', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '88.2', 'spread': '11.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 months of age', 'description': 'Bayley Certified Scales of Infant Development III Edition standard score for motor abilities at 24 months of age.\n\nComposite standard scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160.\n\nHigher scores mean better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Language Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '87.8', 'spread': '20.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 months of age', 'description': 'Bayley Certified Scales of Infant Development III Edition standard score for language abilities at 24 months of age.\n\nComposite standard scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160.\n\nHigher scores mean better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gross Motor Function Classification System at 24 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'title': 'Level I', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Level II', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months of age', 'description': 'Level from the Gross Motor Function Classification System at 24 months of age\n\nLevel I (Handles objects easily and successfully) Level II (Handles most objects, but with somewhat reduced quality and/or speed of achievement) Level III (Handles objects with difficulty) Level IV (Handles a limited selection of easily managed objects in simple actions) Level V (Does not handle objects and has severely limited ability to perform even simple actions)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Children With Hearing Loss at 24 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in the pravastatin group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months of age', 'description': 'Hearing loss at 24 months of age', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Child Behavior Checklist Total Problems T-Score at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '53'}, {'value': '44.5', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '84'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '24 months of age', 'description': 'Total problems T score from the Child Behavior Checklist (CBCL) at 24 months.\n\nThe Child Behavior Checklist (CBCL) is a survey used to detect behavioral and emotional problems in children. The CBCL is filled out by the caregiver. Each of the 100 questions indicates a behavior for which the caregiver scores as Not True (0), Sometimes True (1), or Often True (2). The scores for all the questions are then summed and evaluated against the normative data/T-scores. The raw total scores are converted to norm-referenced T-scores (mean 50, standard deviation of 10). Lower scores represent better outcomes. A T-score of 64 or higher indicates a clinically significant elevation. Lower scores represent better outcomes.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Children With Vision Problems at 24 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20mg Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'OG001', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'RR not reported given zero events in the pravastatin group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months of age', 'description': 'Vision problems (severe nearsightedness or farsightedness, and eye movement problems) at 24 months of age', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}, {'id': 'FG002', 'title': 'Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'FG003', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'comment': 'For the twin gestation in the placebo group, both twins were followed (n=18), however in the analyses, the worst outcome for the twin pair was reported (n=17).', 'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'refused follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This trial began under an FDA clinical hold that limited recruitment to 50 participants of the planned 1,550. The hold was not lifted and the trial was terminated after enrollment of the first 50 participants. We conducted the trial at 13 hospitals. Mothers were enrolled in pregnancy and their offspring followed for 2 years. Recruitment period was Jul 2019 to Dec 2020. Infants were enrolled but were not consented. Two mothers delivered twins resulting in 52 fetus/neonates (26 in each arm).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Pravastatin', 'description': '20 mg pravastatin daily\n\nPravastatin: 20 mg Pravastatin taken daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Identical appearing daily placebo\n\nPlacebo: Identical appearing placebo pill'}, {'id': 'BG002', 'title': 'Pravastatin - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group'}, {'id': 'BG003', 'title': 'Placebo - Fetus/ Neonates /Infants', 'description': 'Fetus/Neonates /Infants of participants in the placebo group'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '31.6', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '5.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian/Alaskan Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian / Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'More than 1 self-reported race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.'}, {'title': 'Chronic Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.'}, {'title': 'Twin pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.'}, {'title': 'Gestational age at randomization', 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'groupId': 'BG000', 'lowerLimit': '12.0', 'upperLimit': '16.9'}, {'value': '15.4', 'groupId': 'BG001', 'lowerLimit': '12.0', 'upperLimit': '16.9'}, {'value': '14.9', 'groupId': 'BG004', 'lowerLimit': '12.0', 'upperLimit': '16.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'Observed gestational age at randomization', 'unitOfMeasure': 'weeks', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.'}], 'populationDescription': 'Baseline characteristics are for the pregnant mothers only as the offspring were not born at the time of randomization.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-08', 'size': 792046, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-13T13:56', 'hasProtocol': True}, {'date': '2022-05-03', 'size': 348970, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-13T14:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Consenting women will be assigned to pravastatin or placebo in a 1:1 ratio according to a randomization sequence prepared and maintained centrally by the Data Coordinating Center (DCC). The two study medication arms of the study (pravastatin or placebo) are double masked; neither the patient nor the clinical staff will be aware of the treatment assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a randomized controlled multi-center clinical trial of 1,550 women with a prior history of preeclampsia that required delivery at less than or equal to 34 weeks 0 days gestation, randomized to one of two arms at participating Maternal Fetal Medicine Units Network clinical centers.\n\n* 20 mg pravastatin daily\n* Identical appearing daily placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'whyStopped': 'participants are no longer being examined or receiving intervention', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2019-05-07', 'resultsFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2019-05-08', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-09', 'studyFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Composite of Preeclampsia, Fetal Loss and Maternal Death', 'timeFrame': '48 hours postpartum', 'description': 'Proportion of participants demonstrating a composite of preeclampsia, fetal loss, or maternal death.\n\n1. Baseline Normotensive: a) Severe hypertension (HTN) or b) Mild HTN w/ any of the following: i.) New-onset proteinuria or doubling in protein w/ baseline proteinuria ii.) Thrombocytopenia iii.) Progressive renal insufficiency iv). Impaired liver function v.) Pulmonary edema vi.) New-onset \\& persistent cerebral or visual symptoms\n2. Baseline chronic HTN: any of the following a)Severe HTN b) New onset proteinuria or doubling in protein from baseline proteinuria c)Thrombocytopenia d) Progressive renal insufficiency e) Impaired liver function f) Pulmonary edema g) New-onset \\& persistent cerebral or visual symptoms.\n3. HELLP a) Hemolysis AND b)Thrombocytopenia AND c) AST/ALT ≥ 70 IU/L\n4. Atypical HELLP an occurrence of 2 of the 3: a) Hemolysis, b)Thrombocytopenia, OR c) AST/ALT ≥ 70 IU/L\n5. Eclampsia\n6. Competing outcomes: maternal death before delivery or fetal loss \\< 20wks, 0 days'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Preeclampsia With Severe Features', 'timeFrame': '48 hours postpartum', 'description': 'Preeclampsia with severe features as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnostic criteria (i.e., severe hypertension, thrombocytopenia, impaired liver function, progressive renal insufficiency, pulmonary edema, new-onset and persistent cerebral or visual symptoms)'}, {'measure': 'Proportion of Participants With Gestational Hypertension', 'timeFrame': '48 hours postpartum', 'description': 'Defined as new onset hypertension in the absence of accompanying proteinuria or other features of preeclampsia'}, {'measure': 'Proportion of Participants With Pregnancy Associated Hypertension', 'timeFrame': '48 hours postpartum', 'description': 'Defined as gestational hypertension or preeclampsia'}, {'measure': 'Proportion of Participants With Postpartum Preeclampsia', 'timeFrame': '48 hours postpartum through 6 weeks post partum', 'description': 'Preeclampsia that occurs more than 48 hours after birth'}, {'measure': 'Proportion of Participants With Gestational Diabetes', 'timeFrame': 'At any time during pregnancy through delivery (up to approximately 30 weeks)', 'description': 'Gestational diabetes mellitus'}, {'measure': 'Rate of Adherence to Study Medication', 'timeFrame': 'Randomization to delivery (up to approximately 30 weeks)', 'description': 'Adherence to the medication regimen for the study (daily pill) defined as the time from randomization to delivery. The earliest gestational age at randomization is 12 weeks and most women deliver by 42 weeks gestation which is why the time frame is up to a maximum of approximately 30 weeks. Given the earlier gestational age of delivery in this cohort, the time period is shorter than 30 weeks.'}, {'measure': 'Proportion of Participants With Severe Maternal Morbidity Composite', 'timeFrame': 'Randomization through 6 weeks postpartum', 'description': 'A composite of severe maternal morbidity of either maternal death, eclampsia, HELLP syndrome, cerebral vascular accident, heart failure, myocardial infarction, acute respiratory distress syndrome requiring mechanical ventilation, disseminated intravascular coagulopathy, pulmonary edema, renal failure, liver rupture, or placental abruption'}, {'measure': 'Length of Maternal Hospital Stay', 'timeFrame': 'Delivery admission through discharge from the hospital (a median of 3 days)', 'description': 'Length of maternal hospital stay for the delivery admission (admission to discharge)'}, {'measure': 'Rate of Adverse Events of Special Interest (AESI) or Serious AESI', 'timeFrame': 'Randomization through 48 hours postpartum', 'description': 'Adverse events of Special Interest (AESI) including myalgia and muscle weakness, and serious AESI include maternal myositis, myopathy, rhabdomyolysis, or serious liver injury'}, {'measure': 'Gestational Age at Delivery', 'timeFrame': 'Delivery', 'description': 'Gestational age at the time of delivery'}, {'measure': 'Proportion of Participants With Preterm Birth < 37 Weeks', 'timeFrame': 'Delivery before 37 weeks', 'description': 'Preterm birth before 37 weeks gestation'}, {'measure': 'Proportion of Participants With Indicated Preterm Birth < 37 Weeks', 'timeFrame': 'Delivery before 37 weeks', 'description': 'Indicated preterm birth less than 37 weeks'}, {'measure': 'Proportion of Participants With Preterm Birth < 34 Weeks', 'timeFrame': 'Delivery before 34 weeks', 'description': 'Preterm birth before 34 weeks gestation'}, {'measure': 'Proportion of Fetal or Neonatal Deaths', 'timeFrame': 'randomization (mother) through 28 days of life (neonate)', 'description': 'Death of the fetus or neonate'}, {'measure': 'Birth Weight', 'timeFrame': 'Birth', 'description': 'Birth weight'}, {'measure': 'Proportion of Small for Gestational Age < 5th Percentile', 'timeFrame': 'Birth', 'description': 'Birthweight \\< 5th percentile'}, {'measure': 'Proportion of Small for Gestational Age < 10th Percentile', 'timeFrame': 'Birth', 'description': 'Birthweight \\< 10th percentile'}, {'measure': 'Proportion of NICU/Intermediate Nursery Admission', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Admission to the neonatal intensive care unit (NICU) or intermediate nursery'}, {'measure': 'NICU/Intermediate Nursery Length of Stay', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Length of stay in the neonatal intensive care unit (NICU) and/or intermediate nursery.'}, {'measure': 'Proportion of Neonates Needing Mechanical Ventilation or Continuous Positive Airway Pressure (CPAP)', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Mechanical ventilation or CPAP support'}, {'measure': 'Proportion of Neonates Needing Oxygen Support', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Provision of oxygen support for the neonate'}, {'measure': 'Proportion of Neonates With Respiratory Distress Syndrome', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Respiratory distress syndrome (RDS), defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis), with an oxygen requirement and confirmed by a chest x-ray'}, {'measure': 'Proportion of Neonates With Bronchopulmonary Dysplasia', 'timeFrame': '28 days of life and 36 weeks corrected gestational age', 'description': 'Bronchopulmonary dysplasia (BPD), defined as oxygen requirement at 28 days of life and at 36 weeks corrected gestational age'}, {'measure': 'Proportion of Neonates With Necrotizing Enterocolitis', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Necrotizing enterocolitis (NEC), defined as modified Bell Stage 2 (clinical signs and symptoms with pneumatosis intestinalis on radiographs) or Stage 3 (advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation)'}, {'measure': 'Proportion of Neonates With Intraventricular Hemorrhage', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Intraventricular hemorrhage (IVH) grade III-IV'}, {'measure': 'Proportion of Neonates With Periventricular Leukomalacia (PVL)', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Periventricular leukomalacia (PVL), diagnosed by neuroimaging'}, {'measure': 'Proportion of Neonates Experiencing Early Onset Sepsis', 'timeFrame': 'Birth to 72 hours from birth', 'description': 'Neonatal sepsis (within first 72 hours after birth). The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebral spinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal radiograph confirming infection.'}, {'measure': 'Proportion of Neonates Experiencing Late Onset Sepsis', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Neonatal sepsis (\\>72 hours after birth). The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebral spinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal radiograph confirming infection.'}, {'measure': 'Proportion of Neonates With Retinopathy of Prematurity', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Retinopathy of prematurity (ROP) stage III or higher'}, {'measure': 'Proportion of Neonates With Composite Neonatal Outcome', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Fetal or neonatal death, RDS, Grade III-IV IVH, PVL, Stage 2 or 3 NEC, BPD, Stage III or higher ROP, or early onset sepsis'}, {'measure': 'Proportion of Neonates Experiencing Seizures', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Neonatal seizure activity'}, {'measure': 'Proportion of Neonates With a Congenital Anomaly / Birth Defect', 'timeFrame': 'Randomization through delivery (up to approximately 30 weeks)', 'description': 'Congenital anomaly or birth defect excluding any conditions that must have been present before randomization'}, {'measure': 'Neonatal Auditory Brain Stem Response (ABR)/Otoacoustic Emissions (OAE)', 'timeFrame': 'Birth through hospital discharge (an average of 4 days)', 'description': 'Neonatal auditory brain stem response (ABR)/Otoacoustic Emissions (OAE) test results of fail/refer.'}, {'measure': 'BMI for Age at 24 Corrected Months', 'timeFrame': '24 months of age', 'description': 'Body mass index for age percentile at 24 corrected months using Centers for Disease Control (CDC) pediatric growth charts'}, {'measure': 'Cognitive Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age', 'timeFrame': '24 months of age', 'description': 'Bayley Certified Scales of Infant Development III Edition standard score for cognitive abilities at 24 months of age.\n\nComposite standard scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160.\n\nHigher scores mean better outcome.'}, {'measure': 'Motor Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age', 'timeFrame': '24 months of age', 'description': 'Bayley Certified Scales of Infant Development III Edition standard score for motor abilities at 24 months of age.\n\nComposite standard scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160.\n\nHigher scores mean better outcome.'}, {'measure': 'Language Standard Score From the Bayley Certified Scales of Infant Development III Edition at 24 Months of Age', 'timeFrame': '24 months of age', 'description': 'Bayley Certified Scales of Infant Development III Edition standard score for language abilities at 24 months of age.\n\nComposite standard scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160.\n\nHigher scores mean better outcome.'}, {'measure': 'Gross Motor Function Classification System at 24 Months of Age', 'timeFrame': '24 months of age', 'description': 'Level from the Gross Motor Function Classification System at 24 months of age\n\nLevel I (Handles objects easily and successfully) Level II (Handles most objects, but with somewhat reduced quality and/or speed of achievement) Level III (Handles objects with difficulty) Level IV (Handles a limited selection of easily managed objects in simple actions) Level V (Does not handle objects and has severely limited ability to perform even simple actions)'}, {'measure': 'Proportion of Children With Hearing Loss at 24 Months of Age', 'timeFrame': '24 months of age', 'description': 'Hearing loss at 24 months of age'}, {'measure': 'Child Behavior Checklist Total Problems T-Score at 24 Months', 'timeFrame': '24 months of age', 'description': 'Total problems T score from the Child Behavior Checklist (CBCL) at 24 months.\n\nThe Child Behavior Checklist (CBCL) is a survey used to detect behavioral and emotional problems in children. The CBCL is filled out by the caregiver. Each of the 100 questions indicates a behavior for which the caregiver scores as Not True (0), Sometimes True (1), or Often True (2). The scores for all the questions are then summed and evaluated against the normative data/T-scores. The raw total scores are converted to norm-referenced T-scores (mean 50, standard deviation of 10). Lower scores represent better outcomes. A T-score of 64 or higher indicates a clinically significant elevation. Lower scores represent better outcomes.'}, {'measure': 'Proportion of Children With Vision Problems at 24 Months of Age', 'timeFrame': '24 months of age', 'description': 'Vision problems (severe nearsightedness or farsightedness, and eye movement problems) at 24 months of age'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Preeclampsia'], 'conditions': ['Preeclampsia', 'Obstetric Labor Complications', 'Hypertension in Pregnancy']}, 'referencesModule': {'references': [{'pmid': '26723196', 'type': 'BACKGROUND', 'citation': "Costantine MM, Cleary K, Hebert MF, Ahmed MS, Brown LM, Ren Z, Easterling TR, Haas DM, Haneline LS, Caritis SN, Venkataramanan R, West H, D'Alton M, Hankins G; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric-Fetal Pharmacology Research Units Network. Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial. Am J Obstet Gynecol. 2016 Jun;214(6):720.e1-720.e17. doi: 10.1016/j.ajog.2015.12.038. Epub 2015 Dec 23."}]}, 'descriptionModule': {'briefSummary': 'This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered early in pregnancy reduces the rate of a composite outcome of preeclampsia, fetal loss and maternal death. Women with a prior history of preeclampsia with preterm delivery less than 34 weeks will be randomized to pravastatin or placebo daily until delivery. Women will have monthly study visits during pregnancy, a follow-up visit at 6 weeks postpartum and children will have follow-up visits at 2 and 5 years of age.', 'detailedDescription': 'Preeclampsia complicates approximately 3% to 5% of pregnancies and remains a major cause of maternal and neonatal morbidities and mortality. Women who experience preeclampsia in one pregnancy are at higher risk of developing preeclampsia in a subsequent pregnancy than those who have never experienced the condition. There is evidence from laboratory studies and clinical trials, as well as biological plausibility, to suggest that statins may prevent the development of preeclampsia by reversing various pathways associated with preeclampsia. Pravastatin has a favorable safety profile and pharmacokinetic properties.\n\nThe study is a randomized placebo-controlled multi-center clinical trial of 1,550 women with a prior history of preeclampsia that required delivery at less than 34 weeks, randomized to either 20mg pravastatin or an identical appearing placebo daily until delivery. Women with a singleton or twin gestation will be randomized between 12 weeks 0 days and 16 weeks 6 days will be followed monthly during pregnancy and then at 6 weeks postpartum. Children will have follow-up visits at 2 and 5 years of age to assess growth, cognition, behavior, motor skills, vision and hearing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 16 years or older at time of consent with ability to give informed consent\n2. Single or twin gestation with cardiac activity in one or both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age.\n3. Gestational age at randomization between 12 weeks 0 days and 16 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.\n4. Documented history (by chart or delivery/operative note review) of prior preeclampsia with delivery less than or equal to 34 weeks 0 days gestation in any previous pregnancy. If in the index pregnancy, the woman was induced by 34 weeks 0 days gestation and delivered within 48 hours in the same hospitalization, that woman would be eligible.\n5. Normal serum transaminase (AST/ALT) concentrations documented in the last 6 months.\n\nExclusion Criteria:\n\n1. Monoamniotic gestation because of the risk of fetal demise\n2. Known chromosomal, genetic or major malformations\n3. Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from triplets to twins or twins to singleton is not an exclusion.\n4. Contraindications for statin therapy:\n\n 1. Hypersensitivity to pravastatin or any component of the product\n 2. Active liver disease: acute hepatitis or chronic active hepatitis\n5. Statin use in current pregnancy\n6. Patients with any of the following medical conditions:\n\n 1. Uncontrolled hypothyroidism with a TSH level above 10 mIU/L, because of increased risk of myopathy\n 2. HIV positive, because of increased risk of myopathy with use of protease inhibitors\n 3. Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL, because of association with adverse pregnancy outcomes\n7. Current use of concomitant medication with potential for drug interaction with statins (i.e.,, cyclosporine, fibrates, niacin, erythromycin). Patients will not be excluded if the drug is discontinued (at least one week) prior to randomization.\n8. Participating in another intervention study that influences the primary outcome in this study\n9. Plan to deliver in a non-network site\n10. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.'}, 'identificationModule': {'nctId': 'NCT03944512', 'acronym': 'Pravastatin', 'briefTitle': 'Pravastatin to Prevent Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'The George Washington University Biostatistics Center'}, 'officialTitle': 'A Randomized Controlled Trial of Pravastatin to Prevent Preeclampsia in High Risk Women', 'orgStudyIdInfo': {'id': 'HD036801-Pravastatin'}, 'secondaryIdInfos': [{'id': '5U10HD036801-20', 'link': 'https://reporter.nih.gov/quickSearch/5U10HD036801-20', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pravastatin', 'description': '20 mg pravastatin daily', 'interventionNames': ['Drug: Pravastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identical appearing daily placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Pravastatin', 'type': 'DRUG', 'description': '20 mg Pravastatin taken daily', 'armGroupLabels': ['Pravastatin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Identical appearing placebo pill', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama - Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve-Metro Health', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Magee Women's Hospital of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Maged Costantine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'Monica Longo, MD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, {'name': 'Rebecca Clifton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The George Washington University Biostatistics Center'}, {'name': 'Victoria Pemberton, RNC, MS, CCRC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Given enrollment was limited to 50 participants, the dataset will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The George Washington University Biostatistics Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}