Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT01983202
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2013-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstetric Outcomes in Women With PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1248}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-06', 'studyFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2013-11-06', 'lastUpdatePostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Neonatal complications', 'timeFrame': 'Date of birth (1 day)', 'description': 'Registration of Apgar score 5 minutes after birth and admission to neonatal intensive care unit.'}], 'primaryOutcomes': [{'measure': 'Anthropometric measures', 'timeFrame': 'Date of birth (1 day)', 'description': 'Abdominal circumference, birth weight, birth length, and head circumference.'}], 'secondaryOutcomes': [{'measure': 'Adverse obstetric outcomes', 'timeFrame': 'From beginning of pregnancy until the date of delivery (approximately 9 months)', 'description': 'Presence of gestational diabetes mellitus, pregnancy induced hypertension, or pre-eclampsia during pregnancy. Registration of gestational age at childbirth, medical induction of birth, caesarean section,instrumental delivery, anal sphincter rupture, and shoulder dystocia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCOS', 'Pregnancy', 'Obstetric'], 'conditions': ['Polycystic Ovary Syndrome, PCOS']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate body composition in newborn children of women with PCOS and controls and to investigate adverse obstetric outcomes in pregnant women with PCOS.', 'detailedDescription': 'A prospective cohort study investigating 208 women with PCOS giving birth after singleton pregnancies at Odense Univesity Hospital during 2003-2011 and a date-of-childbirth matched control group of 1040 women. Anthropometric data from children is recorded as well as data on maternal parity, age, pre-gestational BMI, and adverse obstetric outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '208 women diagnosed with PCOS at Department of Endocrinology and Metabolism and giving birth at Odense University Hospital during 2003-2011. Women with PCOS are matched 1:5 to a date-of-childbirth matched control group of 1040 pregnant women giving birth at Odense UNivesity Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with PCOS and giving birth during 2003-2011\n\nExclusion Criteria:\n\n* Multiple pregnancy'}, 'identificationModule': {'nctId': 'NCT01983202', 'briefTitle': 'Obstetric Outcomes in Women With PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Size at Birth in Newborn Children and Obstetric Outcomes in Women With PCOS', 'orgStudyIdInfo': {'id': '25624548'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with PCOS', 'description': '208 women diagnosed with PCOS and giving birth after singleton pregnancies at Odense University Hospital during 2003-2011.'}, {'label': 'Controls', 'description': '1040 women giving birth after singleton pregnancies at Odense University Hospital during 2003-2011, matched 1:5 to women with PCOS according to date-of-childbirth.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Department of Endocrinology, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Marianne Andersen, DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Marianne Andersen', 'investigatorAffiliation': 'Odense University Hospital'}}}}