Fetal Growth and Pregnancy Complications Among Women With Heart Disease (PreCor)

August 30, 2018 updated by: Ingvil Krarup Sørbye, Oslo University Hospital

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway, 0424
    - Recruiting
    - Oslo University Hospital
    - Contact:
      
      Ingvil K Sørbye, PhD, MD
      
      Phone Number: 70228 +4723070000
      
      Email: isorbye@ous-hf.no
    - Contact:
      
      Ingrid Langen, MD
      
      Phone Number: +4723070000
      
      Email: ingrid.langen@ous-hf.no

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Non-consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Fetal growth cohort Longitudinal measurements of fetal growth, fetal circulation and maternal circulation
Hypertensive cohort Retrospective cohort of women with heart disease that underwent oregnancy and childbirth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal growth Time Frame: From gestational week 12 until time of birth of baby	Serial measurements of fetal biometry	From gestational week 12 until time of birth of baby
Occurrence of hypertension/preeclampsia in pregnancy or postpartum Time Frame: From time of study inclusion until time of discharge from maternity unit after birth of baby	Diagnosis in index pregnancy or postpartum until discharge from maternity unit	From time of study inclusion until time of discharge from maternity unit after birth of baby
Fetoplacental circulation Time Frame: From gestational week 12 until time of birth of baby	Serial measurements of fetoplacental circulation	From gestational week 12 until time of birth of baby

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

Study Director: Mette E Estensen, PhD, MD, Oslo University Hospital, Dep. of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

May 31, 2020

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)