Status:
UNKNOWN
Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida
Lead Sponsor:
Groupe de Recherche Action en Sante
Collaborating Sponsors:
European Vaccine Initiative
Conditions:
Maternal Malaria During Pregnancy - Baby Not Yet Delivered
Eligibility:
FEMALE
15+ years
Brief 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...
Detailed Description
Three subgroups will involve in the design of this study: for subgroup 1, fieldworkers will visit the households in the study area to identify and enroll women meeting the eligibility criteria to inv...
Eligibility Criteria
Inclusion
- 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
- 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 situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Key Trial Info
Start Date :
August 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
2390 Patients enrolled
Trial Details
Trial ID
NCT06162078
Start Date
August 25 2023
End Date
December 1 2024
Last Update
April 19 2024
Active Locations (1)
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1
GRAS-Banfora
Banfora, Burkina Faso, 10248