Valvular Heart DiseaseNCT04936815
Echocardiographic Screening of Pregnant Women During Antenatal Care
A study testing Transthoracic echocardiography in people with Valvular Heart Disease and Rheumatic Heart Disease, run by Thomas Pilgrim at 2 sites in 2 countries.
Trial summary
Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings. Pregnant women presenting to B.P. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Valvular Heart Disease, Rheumatic Heart Disease, Pregnancy Complications
- What is being tested?
- Transthoracic echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2021to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women ≥18 years presenting for routine antenatal care.
- Written informed consent.
Who cannot join
- Women presenting to the hospital after delivery.
- Women presenting directly for delivery without previous antenatal care.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
Department of Cardiology, Bern University Hospital
Bern, 3010
About this study
Official title: Effectiveness of Echocardiographic Screening of Pregnant Women During Antenatal Care
Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings.
Pregnant women presenting to B.P. Koirala Institute of Health Sciences will be prospectively included into a registry upon their visit for antenatal care. Women will be followed until 6 weeks after the time of delivery. Nested within this registry, the investigators will perform a registry-based adaptive cluster randomized crossover trial. The trial compares an experimental condition (echocardiographic screening) and a control condition (routine antenatal care).
Read the detailed description
Latent structural heart disease may result in complications during pregnancy and delivery. Echocardiographic screening of pregnant women allows for timely detection of structural heart disease in women that may complicate delivery and jeopardize the health and well-being of both the mother and the newborn. In a setting of high rates of latent rheumatic heart disease, with particular high prevalence among women, systematic echocardiographic screening may be a pragmatic approach to prevent adverse clinical outcome related to valvular heart failure. Systematic echocardiographic screening proved to be effective among children in endemic regions.
The present study is a registry-based, adaptive cluster randomized crossover trial. The trial will be nested into a registry of pregnant women presenting for routine antenatal care. The experimental condition will be echocardiographic screening. The control condition will be no echocardiographic screening.
In the experimental condition, all pregnant women presenting for routine antenatal care will be offered transthoracic echocardiographic screening for the detection of latent structural heart disease. In the control condition, pregnant women will undergo routine antenatal care with echocardiography only when clinically indicated. Ascertainment of the primary endpoint will be performed at hospital discharge after delivery and will rely on routinely collected data. All events will be independently adjudicated by an expert panel of pediatricians, cardiologists and gynecologists.
The randomization relates solely to the detection of rheumatic heart disease, while treatment follows guideline recommendations. It is important to note, that all women both in the experimental arm and the control arm detected to have heart disease will undergo optimal medical management during pregnancy and delivery according to the most recent guidelines.
- Being tested
- Transthoracic echocardiography
- Medical subject headings
- Heart Valve Diseases, Rheumatic Heart Disease, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDiagnostic test
Transthoracic echocardiography for the detection of congenital or acquired structural heart disease.
| Study group | Role | What they receive |
|---|---|---|
| Echocardiographic screening | Experimental | Echocardiographic screening for the detection of latent structural heart disease Receives: Diagnostic Test: Transthoracic echocardiography |
| Control arm | No intervention | Routine antenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint
Incidence rate of the composite of maternal death, fetal/neonatal death, maternal heart failure, maternal hospitalization for cardiovascular reasons or an APGAR Score <7.
Measured: For APGAR Score: 10 minutes after birth. For all other components of the composite endpoint: Hospital discharge after delivery (on an average of 4 days after delivery) or 7 days after delivery (whatever takes first).
Secondary outcomes (2)
Incidence of maternal adverse events
Death; Cerebrovascular Events; Heart failure; Cardiac interventions; Supraventricular tachycardia, Atrial fibrillation, Ventricular tachycardia; Thrombotic and thromboembolic events; Postpartum haemorrhage.
Measured: 6 weeks after delivery
Incidence of fetal/neonatal adverse events
Death; Preterm birth (<37 weeks); Birthweight <2500g
Measured: 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Dec 2021
- Primary completion30 Nov 2024
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three clusters representing the three administrative units of the Ob/Gyn department will be randomly allocated to an experimental or a control condition. During 18 months, each of the three clusters will undergo a randomly allocated experimental period of 6 months and two control periods of 6 months. Women seen at least once during the experimental period will be offered to undergo systematic echocardiographic screening for structural heart disease followed by guideline-directed peripartum management. Women only seen during the control periods will undergo routine antenatal care and receive echocardiography only if clinically indicated. After 15 months recruitment, the investigators will perform a conditional power analysis. If the conditional power is below 80% but above 50%, and an extension is considered feasible, the investigators will extend the recruitment duration to 36 months and allocate each administrative unit to another experimental recruitment period of 6 months duration.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Pilgrim
- Sponsor type
- University, hospital or other
- Collaborators
- B.P. Koirala Institute of Health Sciences
- Responsible party
- Sponsor-investigator, Thomas Pilgrim, Insel Gruppe AG, University Hospital Bern
- Investigators
- Thomas Pilgrim, MD, MSc, Principal investigator, Department of Cardiology, Bern University Hospital, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936815
- Sponsor's protocol ID
- IRC/2121/021
- Status last verified
- Jan 2026
- First submitted
- 15 Jun 2021
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Echocardiographic Screening of Pregnant Women During Antenatal Care
- ClinicalTrials.gov ID
- NCT04936815
- Acronym / sponsor ID
- IRC/2121/021
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Thomas PilgrimUniversity, hospital or other
- Collaborators
- B.P. Koirala Institute of Health Sciences
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 23 Jun 2021 (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.
Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings.
Pregnant women presenting to B.P. Koirala Institute of Health Sciences will be prospectively included into a registry upon their visit for antenatal care. Women will be followed until 6 weeks after the time of delivery. Nested within this registry, the investigators will perform a registry-based adaptive cluster randomized crossover trial. The trial compares an experimental condition (echocardiographic screening) and a control condition (routine antenatal care).
Detailed description
Latent structural heart disease may result in complications during pregnancy and delivery. Echocardiographic screening of pregnant women allows for timely detection of structural heart disease in women that may complicate delivery and jeopardize the health and well-being of both the mother and the newborn. In a setting of high rates of latent rheumatic heart disease, with particular high prevalence among women, systematic echocardiographic screening may be a pragmatic approach to prevent adverse clinical outcome related to valvular heart failure. Systematic echocardiographic screening proved to be effective among children in endemic regions.
The present study is a registry-based, adaptive cluster randomized crossover trial. The trial will be nested into a registry of pregnant women presenting for routine antenatal care. The experimental condition will be echocardiographic screening. The control condition will be no echocardiographic screening.
In the experimental condition, all pregnant women presenting for routine antenatal care will be offered transthoracic echocardiographic screening for the detection of latent structural heart disease. In the control condition, pregnant women will undergo routine antenatal care with echocardiography only when clinically indicated. Ascertainment of the primary endpoint will be performed at hospital discharge after delivery and will rely on routinely collected data. All events will be independently adjudicated by an expert panel of pediatricians, cardiologists and gynecologists.
The randomization relates solely to the detection of rheumatic heart disease, while treatment follows guideline recommendations. It is important to note, that all women both in the experimental arm and the control arm detected to have heart disease will undergo optimal medical management during pregnancy and delivery according to the most recent guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Three clusters representing the three administrative units of the Ob/Gyn department will be randomly allocated to an experimental or a control condition. During 18 months, each of the three clusters will undergo a randomly allocated experimental period of 6 months and two control periods of 6 months. Women seen at least once during the experimental period will be offered to undergo systematic echocardiographic screening for structural heart disease followed by guideline-directed peripartum management. Women only seen during the control periods will undergo routine antenatal care and receive echocardiography only if clinically indicated. After 15 months recruitment, the investigators will perform a conditional power analysis. If the conditional power is below 80% but above 50%, and an extension is considered feasible, the investigators will extend the recruitment duration to 36 months and allocate each administrative unit to another experimental recruitment period of 6 months duration.
| Arm | Type | Receives |
|---|---|---|
| Echocardiographic screening | Experimental | Diagnostic Test: Transthoracic echocardiographyEchocardiographic screening for the detection of latent structural heart disease |
| Control arm | No intervention | –Routine antenatal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women ≥18 years presenting for routine antenatal care.
- Written informed consent.
Key exclusion criteria (2 listed)
- Women presenting to the hospital after delivery.
- Women presenting directly for delivery without previous antenatal care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiographyTransthoracic echocardiography for the detection of congenital or acquired structural heart disease. | Diagnostic test | Echocardiographic screening |
Primary outcome
Composite endpoint
Time frame: For APGAR Score: 10 minutes after birth. For all other components of the composite endpoint: Hospital discharge after delivery (on an average of 4 days after delivery) or 7 days after delivery (whatever takes first).
Incidence rate of the composite of maternal death, fetal/neonatal death, maternal heart failure, maternal hospitalization for cardiovascular reasons or an APGAR Score <7.
2 secondary outcomes
Incidence of maternal adverse events
Time frame: 6 weeks after delivery
Incidence of fetal/neonatal adverse events
Time frame: 6 weeks after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Thomas Pilgrim, MD, MSc principal investigator
Department of Cardiology, Bern University Hospital, Switzerland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic echocardiography in people with Valvular Heart Disease and Rheumatic Heart Disease, run by Thomas Pilgrim at 2 sites in 2 countries.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint (time frame: For APGAR Score: 10 minutes after birth. For all other components of the composite endpoint: Hospital discharge after delivery (on an average of 4 days after delivery) or 7 days after delivery (whatever takes first).). 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 20 Jan 2026.