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

Pregnancy Complications Clinical Trial

— CoPPer  

Official title:

Complications of PCOS Pregnancy: Evaluating Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821379
• Other study ID #: CoPPer study - 07/331
• Secondary ID: NL 20244.041.07
• Status: Completed
• Phase: N/A
• First received: January 12, 2009
• Last updated: December 19, 2012
• Start date: April 2008
• Est. completion date: September 2012

Study information

• Verified date: January 2009
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delivery Complications
• Neonatal Complications
• Polycystic Ovary Syndrome
• Pregnancy Complications

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
UMC Utrecht	Erasmus Medical Center, The Queen Elizabeth Hospital, VU University Medical Center

Country where clinical trial is conducted

Netherlands,