CoPPer Study - Complications of Polycystic Ovary Syndrome (PCOS) Pregnancy: Evaluating Risk

Completed

• Conditions: Delivery Complications; Neonatal Complications; Pregnancy Complications

• Registration Number: NCT00821379
• Lead Sponsor: UMC Utrecht

Brief Summary

The CoPPer study is a follow-up study of women diagnosed with Polycystic Ovary Syndrome (PCOS). Women will be included pre-conceptional and followed-up until after delivery. The investigators will design a multivariate prediction model of pregnancy outcome in women with PCOS with the intention to define intervention strategies for the future.

Detailed Description

Background of the study:

PCOS is a heterogeneous condition in which metabolic disturbances such as insulin resistance are common. Pregnancies in women with PCOS are reported to have an increased chance of being complicated by gestational diabetes, pregnancy induced hypertension and pre-eclampsia. Subsequently their offspring are reported to have a lower birth weight and higher risk of admission to a neonatal intensive care unit. However, the cause of increased complication rate is not yet identified.

There is evidence that intra-uterine conditions as well as pre- and periconception factors influence not only neonatal outcome, but also long-term health of the child. Therefore early detection and treatment of pregnancy complications is important for both mother and child.

In order to identify high risk PCOS pregnancies, the specific effects of PCOS on pregnancy in comparison to the background effects need further investigation.

Preconceptional risk assessment of PCOS women is needed to improve antenatal health care and pregnancy outcome of PCOS pregnancies in the future.

Objective of the study:

To design a multivariate prediction model of pregnancy outcome in women with PCOS with the intention to define intervention strategies for the future.

Study design:

Prospective multi-centre follow-up cohort study.

Method:

Women with PCOS will be screened and included in the study pre-conceptionally. Endocrinological values, glucose tolerance and ultrasound scan etc will be recorded. During pregnancy, blood samples will be stored regularly and glucose measurement will be done. Post-partum the pregnancy outcome will be recorded.

Study Timeline

• Study Start: 2008-04
• Status Verified: 2009-01
• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Primary Completion: 2011-01
• Study Completion: 2012-09
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Women with PCOS
• 18 to 40 years old, who wish to conceive.

Exclusion Criteria

• Women with anovulation that is not caused by PCOS
• Women with a language barrier
• Women under 18 or over 40 years of age will be excluded from participation.

Other exclusion criteria are:

• Unresolved medical conditions
• Established type 1 diabetes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands