UnknownNot Applicable

Fetal Growth and Pregnancy Complications Among Women With Heart Disease

Norway800 participantsStarted 2018-05-15

Plain-language 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.

Who can participate

Age range

16 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnant women diagnosed with heart disease before or during pregnancy classified as maternal WHO risk class 2-4 Exclusion Criteria: * Non-consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fetal growth

Timeframe: From gestational week 12 until time of birth of baby

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

Fetoplacental circulation

Timeframe: From gestational week 12 until time of birth of baby

Trial details

NCT IDNCT03657823

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-04-30

Contact for this trial

Ingvil K Sørbye, PhD, MD

+4723070000 isorbye@ous-hf.no

View on ClinicalTrials.gov More Congenital Heart Disease trials

Plain-language summary

Who can participate

Age range

16 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnant women diagnosed with heart disease before or during pregnancy classified as maternal WHO risk class 2-4 Exclusion Criteria: * Non-consent

What they're measuring

Fetal growth

Timeframe: From gestational week 12 until time of birth of baby

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

Fetoplacental circulation

Timeframe: From gestational week 12 until time of birth of baby