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

December 19, 2012 updated by: UMC Utrecht

Complications of 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508 GA
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with PCOS and a wish to conceive who attend to the University Hospital in Utrecht.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

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

Investigators

  • Study Director: Bart CJ Fauser, MD PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 12, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Estimate)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoPPer study - 07/331
  • NL 20244.041.07 (ABR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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