Screening for Pregnancy Related Heart Failure in Nigeria

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2024-05-15

Brief Summary

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This study will evaluate the effectiveness of an artificial intelligence-enabled ECG (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria.

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Detailed Description

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Conditions

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Cardiomyopathy Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Intervention

Participants will have ECGs analyzed with artificial intelligence for cardiomyopathy detection.

Group Type EXPERIMENTAL

Digital stethoscope electrocardiogram

Intervention Type OTHER

Digital stethoscope artificial intelligence enabled electrocardiogram (AI-ECG). An artificial intelligence algorithm which analyses ECG data and generates prediction probabilities for a diagnosis of cardiomyopathy.

Control

Participants will have standard clinical ECGs acquired.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital stethoscope electrocardiogram

Digital stethoscope artificial intelligence enabled electrocardiogram (AI-ECG). An artificial intelligence algorithm which analyses ECG data and generates prediction probabilities for a diagnosis of cardiomyopathy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Currently pregnant or within 12 months postpartum
* Willing and able to provide informed consent

Exclusion Criteria

* Complex congenital heart disease (single ventricle physiology or significant shunts with cardiac structural changes)
* Significant conduction abnormalities (ventricular pacing on recorded ECG, pacemaker dependence, or severely abnormal/bizarre QRS morphology on ECG tracings)
* Unable or unwilling to provide consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes