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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

Tracking Information
First Submitted Date August 29, 2018
First Posted Date September 5, 2018
Last Update Posted Date September 5, 2018
Actual Study Start Date May 15, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 30, 2018)
  • Fetal growth [ Time Frame: From gestational week 12 until time of birth of baby ]
    Serial measurements of fetal biometry
  • 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
  • Fetoplacental circulation [ Time Frame: From gestational week 12 until time of birth of baby ]
    Serial measurements of fetoplacental circulation
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 9 Months
Biospecimen Retention:   Samples Without DNA
Description:
Biomarkers in maternal serum iin subgroups
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.
Condition
  • Congenital Heart Disease
  • Pregnancy Complications
  • Arrhythmias, Cardiac
  • Hypertension in Pregnancy
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 30, 2018)
800
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ingvil K Sørbye, PhD, MD +4723070000 ext 70228 isorbye@ous-hf.no
Contact: Ingrid Langen, MD +4723070000 ingrid.langen@ous-hf.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03657823
Other Study ID Numbers 2018/414
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Upon individual application
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: After June 2021
Access Criteria: Upon individual application
Responsible Party Ingvil Krarup Sørbye, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators Not Provided
Investigators
Study Director: Mette E Estensen, PhD, MD Oslo University Hospital, Dep. of Cardiology
PRS Account Oslo University Hospital
Verification Date August 2018