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New drug combo could cut malaria risks in pregnancy

NCT ID NCT04336189

Prevention Sponsor: Grant Dorsey, M.D, Ph.D. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large phase 3 trial tested whether combining two malaria drugs (SP and DP) works better than either alone to prevent malaria and improve birth outcomes in pregnant women. Over 2,700 HIV-negative women in Uganda received monthly doses of SP, DP, or both. The study tracked complications like low birth weight, preterm birth, and stillbirth to find the safest and most effective regimen.

What this could mean

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

Active substance
Sulfadoxine-pyrimethamine (SP) and dihydroartemisinin-piperaquine (DP)
What this could lead to
If successful, this could lead to a more effective preventive treatment for malaria during pregnancy, reducing risks like low birth weight and preterm birth.
What could go wrong
The trial is completed but results are not yet widely confirmed. The combination may cause more side effects or not work better than existing treatments.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,757 people

The number who actually took part.

Started

Dec 2020

Finished

Jul 2024

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.

Ages

16 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.

Inclusion Criteria: 1. Viable singleton pregnancy confirmed by ultrasound 2. Estimated gestational age between 12-20 weeks 3. Confirmed to be HIV- uninfected by rapid test 4. 16 years of age or older 5. Residency within Busia District of Uganda 6. Provision of informed consent 7. Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol 8. Willing to deliver in the hospital Exclusion Criteria: 1. History of serious adverse event to SP or DP 2. Active medical problem requiring inpatient evaluation at the time of screening 3. Intention of moving outside of Busia District Uganda 4. Chronic medical condition requiring frequent medical attention 5. Prior chemopreventive therapy or any other antimalarial therapy during this pregnancy 6. Early or active labor (documented by cervical change with uterine contractions) 7. Multiple pregnancies (i.e. twins/triplets)

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Conditions

The condition(s) this trial relates to.

Reproductive Tract Infections malaria prevention target

As listed by the trial registrant

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

Malaria

Contacts and locations

Locations

  • Infectious Diseases Research Collaboration Clinic - Masafu Hospital

    Masafu, Busia, Uganda

More trials for these conditions

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