CompletedNot Applicable

MiMBa Pregnancy Registry

Burkina Faso, Kenya15,391 participantsStarted 2021-02-22

Plain-language summary

The MiMBa (Malaria in Mothers and Babies) Pregnancy Registry aims to generate robust evidence on the safety of a range of antimalarials when used in pregnancy, particularly in the first trimester. This will be a multi-country observational study and will be deployed in several field sites in Africa.

Who can participate

Age range

15 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Miscarriage

Timeframe: Between pregnancy identification and 28 weeks gestation

Stillbirth

Timeframe: Between pregnancy identification and delivery

Major congenital anomalies

Timeframe: Up to 12 months after birth

Trial details

NCT IDNCT04825782

SponsorLiverpool School of Tropical Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Malaria in Pregnancy trials