Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida (NCT06162078) | Clinical Trial Compass
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Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida
Burkina Faso2,390 participantsStarted 2023-08-25
Plain-language summary
The overarching aims of this study are to longitudinally determine the occurrence of pregnancy in a cohort of nulligravida at the community level and to estimate the burden of malaria infection during the course of the pregnancy till delivery.
Who can participate
Age range
15 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:
* For subgroup 1
* Nulligravidae aged ≥ 15 years
* Residing within the study area and planning to stay for the study duration
* Signed or thumb-printed informed consent obtained from participant/participant legally acceptable representatives. An assent will be obtained from minors.
* For subgroups 2 and 3
* Primigravidae aged ≥ 15 years at the time of enrolment
* Residing within the study area for the last three months
* Signed or thumb-printed informed consent obtained from participant/participant legally acceptable representatives. An assent will be obtained from minors.
* Additional criteria for subgroup 3 • Third trimester of gestational age
Exclusion Criteria:
* For subgroup 1 only
* Women of non-childbearing potential. Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
* Women reporting established use of oral, injected or implanted hormonal contraceptives; intrauterine device or intrauterine system
* For all the subgroups
* Chronic use of i) immunosuppressive drugs, ii) or other immune modifying drugs within three months prior to enrolment in the study
* Known history of Human Immunodeficiency Virus (HIV) (No test will be done by the study)
* Use of any other investigational or non-registered product (drug or vaccine) during the study period.
* Any previous participation in any malaria (vaccine) study.
* Any other condition or…
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
Proportion of nulliparous with positive urine test
Timeframe: 9 months
2
P. falciparum infection in nulliparous attending the antenatal care visit
Timeframe: 9 months
3
Moderate and severe anemia during the last antenatal care visit