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Complications of PCOS Pregnancy: Evaluating Risk

18 Years
40 Years
Not Enrolling
Pregnancy Complications, Delivery Complications, Neonatal Complications

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Trial Information

Complications of PCOS Pregnancy: Evaluating Risk

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.


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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Bart CJ Fauser, MD PhD

Investigator Role:

Study Director

Investigator Affiliation:

UMC Utrecht


Netherlands: Medical Ethics Review Committee (METC)

Study ID:

CoPPer study - 07/331



Start Date:

April 2008

Completion Date:

September 2012

Related Keywords:

  • Pregnancy Complications
  • Delivery Complications
  • Neonatal Complications
  • PCOS
  • Polycystic Ovary Syndrome
  • Pregnancy Complications
  • Gestational Diabetes
  • Pre eclampsia
  • Prediction Model
  • Pre conceptional
  • Polycystic Ovary Syndrome
  • Pregnancy Complications