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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Complications of PCOS Pregnancy: Evaluating Risk|
Whole blood, serum and lithium heparine, urine and placenta tissue
|Study Start Date:||April 2008|
|Study Completion Date:||September 2012|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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.
Prospective multi-centre follow-up cohort study.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821379
|Utrecht, Netherlands, 3508 GA|
|Study Director:||Bart CJ Fauser, MD PhD||UMC Utrecht|