Fetal Growth and Pregnancy Complications Among Women With Heart Disease

NCT ID: NCT03657823

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2020-05-31

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.

Conditions

Congenital Heart Disease; Pregnancy Complications; Arrhythmias, Cardiac; Hypertension in Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fetal growth cohort

Longitudinal measurements of fetal growth, fetal circulation and maternal circulation

No interventions assigned to this group

Hypertensive cohort

Retrospective cohort of women with heart disease that underwent oregnancy and childbirth

No interventions assigned to this group

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ingvil Krarup Sørbye

Consultant OBGYN, MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mette E Estensen, PhD, MD

Role: STUDY_DIRECTOR

Oslo University Hospital, Dep. of Cardiology

Locations

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Ingvil K Sørbye, PhD, MD

Role: CONTACT

isorbye@ous-hf.no

+4723070000 ext. 70228

Ingrid Langen, MD

Role: CONTACT

ingrid.langen@ous-hf.no

+4723070000

Facility Contacts

Ingvil K Sørbye, PhD, MD

Role: primary

isorbye@ous-hf.no

+4723070000 ext. 70228

Ingrid Langen, MD

Role: backup

ingrid.langen@ous-hf.no

+4723070000

Other Identifiers

2018/414

Identifier Type: -

Identifier Source: org_study_id