Status:
UNKNOWN
MiMBa Pregnancy Registry
Lead Sponsor:
Liverpool School of Tropical Medicine
Collaborating Sponsors:
Medicines for Malaria Venture
Worldwide Antimalarial Resistance Network
Conditions:
Malaria in Pregnancy
Pregnancy Related
Eligibility:
FEMALE
15-49 years
Brief 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. Thi...
Detailed Description
Background:There is often no, or limited, safety data on drug use in early pregnancy and particularly for drugs targeting tropical diseases because these are not widely used in resource-rich countries...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT04825782
Start Date
February 22 2021
End Date
December 1 2024
Last Update
April 1 2021
Active Locations (1)
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1
Kenya Medical Research Institute
Kisumu, Kenya, 40100