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9,000 pregnant women join study to unlock preterm birth secrets

NCT ID NCT02738892

Knowledge-focused Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 9,000 pregnant women in Zambia from early pregnancy through one year after birth. Researchers collect medical details and biological samples to learn why preterm births happen, with the goal of finding new ways to prevent them. No treatment is given—this is an observation-only study.

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 research could uncover biological causes of preterm birth in Zambian women, pointing toward new prevention methods.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly prevent preterm birth. Findings may not apply to other populations.

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 9,000 people

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

Started

Aug 2015

Expected to finish

Oct 2026

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 study will be conducted at Kamwala Health Centre and the University Teaching Hospital, both in Lusaka, Zambia.

Ages

15 to 49 years

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.

Inclusion Criteria: Pregnant women ≥15 years will be eligible to participate. Additionally, participants will: 1. Have a completed screening ultrasound with gestational age \< 20 weeks 2. Be HIV-uninfected at enrollment (NB: prior to Protocol Version 4.0 \[3 Nov 2017\] enrolled both HIV-infected and uninfected women) 3. Have a singleton or twin pregnancy with fetal heart tones confirmed by ultrasound 4. Reside within Lusaka with no plans to relocate during the study follow-up period 5. Be willing to provide written, informed consent 6. Be willing to allow their infants to participate in the study Exclusion criteria: 1. Pregnant women \> 24 weeks' gestation or with screening ultrasound ≥ 16 weeks 2. Infants born to women not enrolled in the study

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Conditions

The condition(s) this trial relates to.

pregnancy disorder with abortive outcome Premature Birth Stillbirth

As listed by the trial registrant

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

Pregnancy Preterm birth Stillbirth

Contacts and locations

Locations

  • Kamwala Health Centre

    Lusaka, Zambia

  • University Teaching Hospital

    Lusaka, Zambia

More trials for these conditions

Other studies related to the condition(s) this trial covers.