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Can antimalarials be safely used in early pregnancy? a massive registry seeks answers

NCT ID NCT04825782

Knowledge-focused Sponsor: Liverpool School of Tropical Medicine 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This large observational study across multiple African sites tracks pregnant women who use antimalarial drugs, especially in the first trimester. The goal is to assess whether these medications are linked to miscarriage, stillbirth, or major birth defects. By following thousands of pregnancies, researchers hope to generate robust evidence on the safety of these common treatments.

What this could mean

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

Active substance
Antimalarial medications
What this could lead to
If successful, this registry could provide clearer safety data on antimalarials in early pregnancy, helping guide safer treatment choices for pregnant women.
What could go wrong
As an observational registry, it cannot prove cause and effect, and results may be affected by underlying health conditions or incomplete follow-up.

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

15,391 people

The number who actually took part.

Started

Feb 2021

Finished

Dec 2025

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

Women of childbearing age (40,000 to 60,000) and Pregnant Women - approximately 3000 to 5500 per year

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 or women of childbearing age (15-49 years) * Resident within the defined catchment area. Residency status will be defined as having resided in the area for at least four months. * Willingness to attend antenatal care and deliver in the study area. * Willingness to give informed consent (and assent for non-pregnant WOCBAs under 18 years of age). Exclusion Criteria: * Refusal to participate or be followed up to the end of pregnancy. • Any medical, psychiatric, or social condition that would interfere with the ability to provide an accurate medical or drug history or the volunteer's ability to give informed consent (e.g. mentally disabled patients).

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities malaria pregnancy disorder

As listed by the trial registrant

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

Congenital anomaly Malaria in pregnancy Pregnancy related

Contacts and locations

Locations

  • Irss/Crun

    Nanoro, Burkina Faso

  • Kenya Medical Research Institute

    Kisumu, 40100, Kenya

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