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

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ClinicalTrials.gov Identifier: NCT03657823
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ingvil Krarup Sørbye, Oslo University Hospital

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.


Condition or disease
Congenital Heart Disease Pregnancy Complications Arrhythmias, Cardiac Hypertension in Pregnancy

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Fetal Growth and Pregnancy Complications Among Women With Heart Disease in Norway: a Cohort Study
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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



Primary Outcome Measures :
  1. Fetal growth [ Time Frame: From gestational week 12 until time of birth of baby ]
    Serial measurements of fetal biometry

  2. 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

  3. Fetoplacental circulation [ Time Frame: From gestational week 12 until time of birth of baby ]
    Serial measurements of fetoplacental circulation


Biospecimen Retention:   Samples Without DNA
Biomarkers in maternal serum iin subgroups


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657823


Contacts
Contact: Ingvil K Sørbye, PhD, MD +4723070000 ext 70228 isorbye@ous-hf.no
Contact: Ingrid Langen, MD +4723070000 ingrid.langen@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Ingvil K Sørbye, PhD, MD    +4723070000 ext 70228    isorbye@ous-hf.no   
Contact: Ingrid Langen, MD    +4723070000    ingrid.langen@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Mette E Estensen, PhD, MD Oslo University Hospital, Dep. of Cardiology

Responsible Party: Ingvil Krarup Sørbye, Consultant OBGYN, MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03657823     History of Changes
Other Study ID Numbers: 2018/414
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon individual application
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After June 2021
Access Criteria: Upon individual application

Additional relevant MeSH terms:
Heart Diseases
Pregnancy Complications
Arrhythmias, Cardiac
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Cardiovascular Diseases
Pathologic Processes
Hypertension
Vascular Diseases