Congenital Heart Disease Clinical Trial
Official title:
Fetal Growth and Pregnancy Complications Among Women With Heart Disease in Norway: a Cohort Study
An increasing proportion of women with heart disease now go through pregnancy and childbirth.
More knowledge about the risk of complications and adverse outcomes for the mother and the
baby is needed to guide clinical care in this diverse patient group.
The purpose of this study is to, in a cohort of pregnant women with heart disease;
- determine fetal growth, and risk of fetal growth restriction and preterm birth
- determine whether maternal blood biomarkers are associated with development of
preeclampsia, the time of delivery and maternal and perinatal adverse outcomes
- determine the risk of hypertensive pregnancy complications
The expected outcome of the project is to increase the knowledge of optimal diagnosis and
treatment of women with heart disease that go through pregnancy to be able to improve
clinical care and the outcomes for mother and baby.
Heart disease is about to become the most important cause of maternal deaths in
industrialized countries. In addition, heart disease in pregnancy is associated to an
increased rate of fetal growth restriction, premature birth, preeclampsia and other pregnancy
complications for the mother and the baby. As many women with congenital or acquired heart
disease now go through pregnancy and childbirth, more knowledge about the risk of
complications and adverse outcomes for the mother and the baby is needed to guide clinical
care in this diverse patient group.
The National Unit for Pregnancy and Heart Disease is located at Oslo University Hospital,
Rikshospitalet, and receive moderate and high risk pregnant women as referrals from hospitals
nationwide for follow-up and treatment. The unit has established Oslo University Hospital
Register for Pregnancy and Heart disease; a quality register for maternal and fetal outcome
in women with heart disease.
The purpose of this study was therefore to, in a cohort of pregnant women with heart disease;
- determine fetal growth, and risk of fetal growth restriction and preterm birth
- determine whether maternal blood biomarkers are associated with development of
preeclampsia, the time of delivery and maternal and perinatal adverse outcomes
- determine the risk of hypertensive pregnancy complications
By the next two years, 150 patients will be included in two prospective longitudinal studies.
In the first study fetal growth and utero-placental-fetal blood flow will be assessed by
serial measurements at specific gestational ages. The mother`s cardiac function will also be
measured. Primary outcome is fetal growth curve and wellbeing at birth.
In the second study, biomarkers in maternal serum will be measured during the last half of
pregnancy to assess if angiogenetic factors are prognostic for the risk of hypertensive
complications.
In the last study the researchers will use retrospective data from the Oslo University
Hospital Register for Pregnancy and Heart disease to determine the association between heart
disease and hypertensive complications in a retrospective cohort of approximately 800
patients.
The expected outcome of the project is to increase the knowledge of optimal diagnosis and
treatment of women with heart disease that go through pregnancy to be able to improve
clinical care and the outcomes for mother and baby.
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