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

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.

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Key information

Conditions

Pregnancy Complications Adnexal Diseases Cysts Delivery Complications Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hypertension, Pregnancy-Induced Metabolic Diseases Neonatal Complications Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Pre-Eclampsia Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

UMC Utrecht

Utrecht, 3508 GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

Amsterdam UMC, location VUmc
Erasmus Medical Center
The Queen Elizabeth Hospital

Registry information

Official study title

Complications of PCOS Pregnancy: Evaluating Risk

Acronym: CoPPer

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2012
First posted: Jan 13, 2009
Registry last updated: Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed