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 range15 Years
SexFEMALE
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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…
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