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

This study has been completed.
Sponsor:
Collaborators:
The Queen Elizabeth Hospital
Erasmus Medical Center
VU University Medical Center
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00821379
First received: January 12, 2009
Last updated: December 19, 2012
Last verified: January 2009
  Purpose

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.


Condition
Pregnancy Complications
Delivery Complications
Neonatal Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Complications of PCOS Pregnancy: Evaluating Risk

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Biospecimen Retention:   Samples With DNA

Whole blood, serum and lithium heparine, urine and placenta tissue


Enrollment: 300
Study Start Date: April 2008
Study Completion Date: September 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821379

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
The Queen Elizabeth Hospital
Erasmus Medical Center
VU University Medical Center
Investigators
Study Director: Bart CJ Fauser, MD PhD UMC Utrecht
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UMC Utrecht, Department of Obstetrics and Gynaecology
ClinicalTrials.gov Identifier: NCT00821379     History of Changes
Other Study ID Numbers: CoPPer study - 07/331, NL 20244.041.07 (ABR)
Study First Received: January 12, 2009
Last Updated: December 19, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
PCOS
Polycystic Ovary Syndrome
Pregnancy Complications
Gestational Diabetes
Pre eclampsia
Prediction Model
Pre conceptional

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pregnancy Complications
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 10, 2014