Congenital Heart DiseasePreCorNCT03657823
Fetal Growth and Pregnancy Complications Among Women With Heart Disease
An observational study of Congenital Heart Disease and Pregnancy Complications, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Congenital Heart Disease, Pregnancy Complications, Arrhythmias, Cardiac
- How many people
- 800 participants
- Where
- 1 siteNorway
- Study dates
- 15 May 2018to 31 May 2020
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Pregnant women diagnosed with heart disease before or during pregnancy classified as maternal WHO risk class 2-4
Who cannot join
- Non-consent
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0424
Ingvil K Sørbye, PhD, MD, +4723070000 ext. 70228, isorbye@ous-hf.no
Ingrid Langen, MD, +4723070000, ingrid.langen@ous-hf.no
About this study
Official title: 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;
Read more
- 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.
Read the 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
- Medical subject headings
- Heart Defects, Congenital, Pregnancy Complications, Arrhythmias, Cardiac, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Fetal growth
Serial measurements of fetal biometry
Measured: From gestational week 12 until time of birth of baby
Occurrence of hypertension/preeclampsia in pregnancy or postpartum
Diagnosis in index pregnancy or postpartum until discharge from maternity unit
Measured: From time of study inclusion until time of discharge from maternity unit after birth of baby
Fetoplacental circulation
Serial measurements of fetoplacental circulation
Measured: From gestational week 12 until time of birth of baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start15 May 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingvil Krarup Sørbye, Oslo University Hospital
- Investigators
- Mette E Estensen, PhD, MD, Study director, Oslo University Hospital, Dep. of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657823
- Sponsor's protocol ID
- 2018/414
- Acronym
- PreCor
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Individual data sharing
- Yes: Upon individual application
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Growth and Pregnancy Complications Among Women With Heart Disease in Norway: a Cohort Study
- ClinicalTrials.gov ID
- NCT03657823
- Acronym / sponsor ID
- PreCor / 2018/414
- Conditions
- Congenital Heart Disease, Pregnancy Complications, Arrhythmias, Cardiac, Hypertension in Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Pregnant women diagnosed with heart disease before or during pregnancy classified as maternal WHO risk class 2-4
Key exclusion criteria (1 listed)
- Non-consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: Yes. Upon individual application
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette E Estensen, PhD, MD study director
Oslo University Hospital, Dep. of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Pregnancy Complications, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingvil K Sørbye, PhD, MD (+4723070000 ext. 70228, isorbye@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal growth (time frame: From gestational week 12 until time of birth of baby). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.