Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-31 @ 1:01 AM
Study NCT ID:
NCT05262634
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2022-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D007753', 'term': 'Laboratories'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D000072182', 'term': 'Non-Medical Public and Private Facilities'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 713}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of anemia', 'timeFrame': 'one time assessment at baseline', 'description': 'Proportion of anemia in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester'}, {'measure': 'Proportion of hemorrhage', 'timeFrame': 'one time assessment at baseline', 'description': 'Proportion of hemorrhage in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester'}, {'measure': 'Proportion of growth retardation', 'timeFrame': 'one time assessment at baseline', 'description': 'Proportion of growth retardation in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iron deficiency anemia of pregnancy', 'pregnancy outcome', 'perinatal risk', 'maternal risk'], 'conditions': ['Iron Deficiency']}, 'descriptionModule': {'briefSummary': "The primary aim of this retrospective, monocentric study with two parallel groups is to investigate pregnancy outcome in women with iron deficiency in the first trimester. It compares the pregnancy outcome between pregnant women with an iron deficiency and those without an iron deficiency in the first trimester. The study group are pregnant women with a diagnosed iron deficiency in the first trimester, a total of 227 pregnant women. The control group consists of 486 pregnant women without first-trimester iron deficiency. Matching criteria include parity and maternal age. Data from patient files of pregnant women who were treated in the Women's Clinic, University Hospital Basel between 2017 and 2019 are analyzed."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The data comes from the patient files of pregnant women who were treated in the Polyclinic Women's Clinic University Hospital Basel between 2017 and 2019.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women with a documented iron deficiency in the first trimester\n* Pregnant women with normal hematological parameters and iron status in the first trimester\n* Treated at the Women's Clinic, University Hospital in Basel\n\nExclusion Criteria:\n\n* Pregnant women with a documented rejection"}, 'identificationModule': {'nctId': 'NCT05262634', 'briefTitle': 'Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester', 'orgStudyIdInfo': {'id': '2020-02033; bb22Hoesli2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group: iron deficiency', 'description': 'Pregnant women with a documented iron deficiency in the first trimester', 'interventionNames': ['Other: Data collection (laboratory and obstetric results)']}, {'label': 'control group: normal iron status', 'description': 'Pregnant women with normal hematological parameters and iron status in the first trimester', 'interventionNames': ['Other: Data collection (laboratory and obstetric results)']}], 'interventions': [{'name': 'Data collection (laboratory and obstetric results)', 'type': 'OTHER', 'description': 'Maternal data: age, pregnancy, parity, singleton or multiple pregnancy, BMI, obstetric history data, and ethnicity.\n\nLaboratory chemical results: hemoglobin (Hb), number of erythrocytes, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), number of hypochromic erythrocytes (HRC), erythrocyte distribution width (EBW), ferritin, C reactive protein (CRP).\n\nMaternal pregnancy outcomes and complications: Hb before and after delivery, mode of delivery, placenta abruption, preeclampsia/eclampsia, gestational diabetes, gestational cholestasis, pregnancy-induced hypertension, bacteriuria or urinary tract infections, peripartum and postpartum hemorrhage, puerperal infections, uterine subinvolution.\n\nPerinatal outcomes: gestational age, birth weight, intrauterine growth retardation, preterm birth, macrosomia, premature rupture of membranes, Apgar score, intrauterine fetal death, pH values, admission to neonatology', 'armGroupLabels': ['control group: normal iron status', 'study group: iron deficiency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': "Women's Clinic, University Hospital Basel", 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Irene Hoesli, Prof. Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Women's Clinic, University Hospital Basel"}, {'name': 'Gabriela Amstad Bencaiova, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Women's Clinic, University Hospital Basel"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}