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Massive pregnancy study aims to save lives in Low-Income countries

NCT ID NCT05904145

Knowledge-focused Sponsor: George Washington University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is following over 267,000 pregnant women in low- and middle-income countries to understand what factors lead to complications like stillbirth, maternal death, and preterm birth. Researchers will collect data on health risks and outcomes to create a large, harmonized dataset. The goal is to use this information to design better care strategies and policies for mothers and newborns worldwide.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide the data needed to develop better strategies for reducing pregnancy complications and deaths in low-resource settings.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve health. Results depend on accurate data collection across many sites, which can be challenging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 267,897 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The investigators will identify, screen, and enroll pregnant participants through pregnancy surveillance systems, with a goal of identifying pregnancies prior to 20 weeks of pregnancy. Pregnant women will be assessed at \<20, 20, 28, 32, and 36 weeks gestation, at labor and delivery, and at 3 days and 1, 4, 6, 26, and 52 weeks postpartum. Infants will similarly be assessed at 3 days and 1, 4, 6, 26, and 52 weeks of age.

Ages

15 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

A woman who meets the following inclusion criteria during screening may be enrolled: * Lives within the study catchment area; * Meets minimum age requirement in study site country: * Ghana: 15 years of age; * Kenya: 18 years of age or those who meet the criteria of emancipated minors; * Pakistan: 15 years of age or those who meet the criteria of emancipated minors; * Zambia: 15 years of age; * India: 18 years of age * Intrauterine pregnancy \<20 weeks gestation verified via ultrasound; * Provides informed consent. A woman who meets the following exclusion criteria during screening may NOT be enrolled: * Nonviable (e.g. ectopic or molar) pregnancy; * Plans to relocate outside of the study catchment area during pregnancy and/or postpartum.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pregnancy, high risk

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aga Khan University

    RECRUITING

    Karachi, Pakistan

  • Christian Medical College (CMC) Vellore

    RECRUITING

    Vellore, India

  • Kenya Medical Research Institute-Center for Global Health Research

    ACTIVE_NOT_RECRUITING

    Kisumu, Kenya

  • Kintampo Health Research Centre

    COMPLETED

    Kintampo, Ghana

  • University of North Carolina-Global Projects Zambia

    COMPLETED

    Lusaka, Zambia

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