Clinical trial NCT03657823: Fetal Growth and Pregnancy Complications Among Women With Heart Disease
Official title: Fetal Growth and Pregnancy Complications Among Women With Heart Disease in Norway: a Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Pregnancy Complications
Arrhythmias, Cardiac
Hypertension in Pregnancy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 800
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with congenital or aquired heart disease that are enrolled or referred to Oslo University Hospital for follow-up in pregnancy and childbirth according to criteria set by the Norwegian National Treatment Unit for Heart Disease and Pregnancy.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women diagnosed with heart disease before or during pregnancy classified as maternal WHO risk class 2-4

Exclusion Criteria:

* Non-consent

Primary outcomes:
measure: Fetal growth
timeFrame: From gestational week 12 until time of birth of baby
measure: Occurrence of hypertension/preeclampsia in pregnancy or postpartum
timeFrame: From time of study inclusion until time of discharge from maternity unit after birth of baby
measure: Fetoplacental circulation
timeFrame: From gestational week 12 until time of birth of baby
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Dep. of Cardiology
name: Mette E Estensen, PhD, MD
role: STUDY_DIRECTOR
References: