Obstetric Outcomes in Women With PCOS

Polycystic Ovary Syndrome, PCOS Clinical Trial

Official title:

Size at Birth in Newborn Children and Obstetric Outcomes in Women With PCOS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983202
• Other study ID #: 25624548
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: November 6, 2013
• Start date: January 2003
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1248
• Est. completion date: September 2013
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed with PCOS and giving birth during 2003-2011

Exclusion Criteria:

• Multiple pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome, PCOS

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonatal complications	Registration of Apgar score 5 minutes after birth and admission to neonatal intensive care unit.	Date of birth (1 day)	No
Primary	Anthropometric measures	Abdominal circumference, birth weight, birth length, and head circumference.	Date of birth (1 day)	No
Secondary	Adverse obstetric outcomes	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.	From beginning of pregnancy until the date of delivery (approximately 9 months)	No