Obstetric Outcomes in Women With PCOS

Completed

• Conditions: Polycystic Ovary Syndrome, PCOS

• Registration Number: NCT01983202
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2011-01
• Study Completion: 2013-09
• Study First Submitted: 2013-10-24
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-06
• Last Update Submitted: 2013-11-06
• Study First Posted: 2013-11-13
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1248

Inclusion Criteria

• Diagnosed with PCOS and giving birth during 2003-2011

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Exclusion Criteria

• Multiple pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anthropometric measures	Date of birth (1 day)	Abdominal circumference, birth weight, birth length, and head circumference.

Secondary Outcome Measures

Name	Time	Method
Adverse obstetric outcomes	From beginning of pregnancy until the date of delivery (approximately 9 months)	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.

Trial Locations

Locations (1)

Department of Endocrinology, Odense University Hospital; 🇩🇰 Odense, Denmark