To collect maternal blood during the 2nd half of pregnany, in combination with clinical data and data on pregnancy outcome.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The initial validation of factors with putative prognostic value for pregnancy
complications that threaten health of mother and/or child.
Secondary outcome
none
Background summary
About 25% of all pregnancies is complicated by gestational diseases that
threaten well-being of mother and/or child. Severe preeclampsia (de novo
hypetension and proteinuria after 20 weeks of gestation) and HELLP (acronym for
Hemolysis, Elevated Liver enzymes and Low Platelets) syndrome are the main
causes for pregancy-related maternal mortality and morbidity. Intra-uterine
growth retardation and premature delivery are the most prevalent additional
causes of neonatal mortality and morbidity.
Recent investigations have identified a number of factors, mainly of placental
origin, with a putative prognostic potential for pregnancy complications. The
recently terminated PANDA study on placental profiles for gestational
hypertensive disease has identified transcripts with increased expression in
the placenta of women with pregnancy complications. These factors, that are
present in the maternal circulation early in pregnancy, have a putative
prognostic potential. Prognostic factors for obstetrical complications are
important because this allows for more intensive monitoring of high risk
patients and possibly also timely treatment in future. Before prospective
studies on the prognostic value of these factors can be initiated, it first has
to be established that they are able to differentiate between pregnant women
with and without gestational disease.
Study objective
To collect maternal blood during the 2nd half of pregnany, in combination with
clinical data and data on pregnancy outcome.
Study design
This is an observational study. Pregnant women admitted to the AMC obstetrical
ward will be asked to participate. The collected EDTA blood will be used to
determine the levels of placenta specific RNA moleculaes and proteins.
Study burden and risks
By means of a venipuncture 1 sample of 10 ml EDTA blood will be collected. This
will be done maximally 3 times with a maximum frequency of 1 puncture per 7
days. Sampling will be combined with the taking of blood samples because of
regular clinical care, as much as possible. The burden of a venipuncture is
minimal. The risks are those associated with a venipuncture; a mild sore spot
or a hematoma.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
pregnant and admitted to the Obstetrics department during the 2nd half of pregnancy
Exclusion criteria
HIV positive
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 | NL31931.018.10 |