Obstetric Outcomes in Women With PCOS
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.
Polycystic Ovary Syndrome, PCOS
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Size at Birth in Newborn Children and Obstetric Outcomes in Women With PCOS|
- Anthropometric measures [ Time Frame: Date of birth (1 day) ] [ Designated as safety issue: No ]Abdominal circumference, birth weight, birth length, and head circumference.
- Adverse obstetric outcomes [ Time Frame: From beginning of pregnancy until the date of delivery (approximately 9 months) ] [ Designated as safety issue: No ]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.
- Neonatal complications [ Time Frame: Date of birth (1 day) ] [ Designated as safety issue: No ]Registration of Apgar score 5 minutes after birth and admission to neonatal intensive care unit.
|Study Start Date:||January 2003|
|Study Completion Date:||September 2013|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Women with PCOS
208 women diagnosed with PCOS and giving birth after singleton pregnancies at Odense University Hospital during 2003-2011.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01983202
|Department of Endocrinology, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Marianne Andersen, DMSci||Odense University Hospital|