To design a multivariate prediction model of pregnancy outcome in women with PCOS with the intention to define intervention strategies for the future.
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
- Pregnancy, labour, delivery and postpartum conditions
- Gonadotrophin and sex hormone changes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maternal and perinatal complications in women with PCOS.
Secondary outcome
Several secondary outcomes will be studied as well. For example:
Miscarriage rate.
Maternal complications such as; Gestational diabetes, pregnancy induced
hypertension, pre-eclampsia.
Perinatal complications such as; Pre-term birth, abnormal birth weight,
admission to a neonatal ward.
Background summary
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.
Study objective
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.
Study burden and risks
The burden associated with participating in the study will be mostly
originating from repetitive blood sampling. Participation in the study may be
of some benefit to the women since they will be monitored more closely than in
normal antenatal care.
Heidelberglaan 100 Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100 Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Women diagnosed with PCOS (according to Rotterdam criteria) who wish to conceive
- Age 18-40yr
Exclusion criteria
Age <18 or >40yr, unresolved other medical conditions, Diabetes type 1
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL20244.041.07 |