Pregnancy Registry in Mali (NCT06468319) | Clinical Trial Compass
RecruitingNot Applicable
Pregnancy Registry in Mali
Mali9,500 participantsStarted 2024-08-05
Plain-language summary
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.
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
. Females of childbearing potential or pregnant females.
. Aged 15 to 49 years.
. Able to provide verbal individual informed consent.
. Pregnant females 15 to 49 years and their subsequent offspring.
. Resides in or in the health catchment area of Kalifabougou and willing to return to the health center for Antenatal Care (ANC) visits.
. Able to provide written individual informed consent for herself and her future offspring(s).
Exclusion criteria
. Temporary residence in the study area.
. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.
. Temporary residence in the study area.
. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.
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
1
Number of pregnancies
Timeframe: Through study completion, an average of 1 year
2
Number of malaria cases
Timeframe: Through study completion, an average of 1 year
3
Incidence of placental malaria
Timeframe: Through study completion, an average of 1 year
4
Use of other malaria prevention tools
Timeframe: Through study completion, an average of 1 year
5
Number of Participants with anemia during pregnancy and post-partum
Timeframe: Through study completion, an average of 1 year
6
Dating of pregnancies
Timeframe: Through study completion, an average of 1 year
7
Number of Maternal Deaths
Timeframe: Through study completion, an average of 1 year
8
Trial details
NCT IDNCT06468319
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)