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Echocardiographic Screening of Pregnant Women During Antenatal Care

NCT ID: NCT04936815

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

9000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Valvular Heart Disease Rheumatic Heart Disease Pregnancy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Echocardiographic screening

Echocardiographic screening for the detection of latent structural heart disease

Group Type EXPERIMENTAL

Transthoracic echocardiography

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiography for the detection of congenital or acquired structural heart disease.

Control arm

Routine antenatal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transthoracic echocardiography

Transthoracic echocardiography for the detection of congenital or acquired structural heart disease.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Pregnant women ≥18 years presenting for routine antenatal care.
* Written informed consent.

Exclusion Criteria

* Women presenting to the hospital after delivery.
* Women presenting directly for delivery without previous antenatal care.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role collaborator

Thomas Pilgrim

OTHER

Sponsor Role lead

Responsible Party

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Thomas Pilgrim

Deputy Physician-in-Chief

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thomas Pilgrim, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Bern University Hospital, Switzerland

Locations

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B.P. Koirala Institute of Health Sciences

Dharān, , Nepal

Site Status RECRUITING

Department of Cardiology, Bern University Hospital

Bern, , Switzerland

Site Status NOT_YET_RECRUITING

Countries

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Nepal Switzerland

Central Contacts

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Surendra Uranw, MPH

Role: CONTACT

Phone: 00977 9842042705

Email: [email protected]

Facility Contacts

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Surendra Uranw, Dr.

Role: primary

Other Identifiers

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IRC/2121/021

Identifier Type: -

Identifier Source: org_study_id