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

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ClinicalTrials.gov Identifier: NCT00821379
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : December 20, 2012
Sponsor:
Collaborators:
The Queen Elizabeth Hospital
Erasmus Medical Center
VU University Medical Center
Information provided by:
UMC Utrecht

Tracking Information
First Submitted Date January 12, 2009
First Posted Date January 13, 2009
Last Update Posted Date December 20, 2012
Study Start Date April 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CoPPer Study - Complications of Polycystic Ovary Syndrome (PCOS) Pregnancy: Evaluating Risk
Official Title Complications of PCOS Pregnancy: Evaluating Risk
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum and lithium heparine, urine and placenta tissue
Sampling Method Non-Probability Sample
Study Population Women with PCOS and a wish to conceive who attend to the University Hospital in Utrecht.
Condition
  • Pregnancy Complications
  • Delivery Complications
  • Neonatal Complications
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January¬†12,¬†2009)
300
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00821379
Other Study ID Numbers CoPPer study - 07/331
NL 20244.041.07 (ABR)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party UMC Utrecht, Department of Obstetrics and Gynaecology
Study Sponsor UMC Utrecht
Collaborators
  • The Queen Elizabeth Hospital
  • Erasmus Medical Center
  • VU University Medical Center
Investigators
Study Director: Bart CJ Fauser, MD PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date January 2009