A Baseline Epidemiological Study to Document the Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida to Targeted Futur Malaria Vaccine Candidate Efficacy in Pregnancy in Burkina Faso
Status: Recruiting
Location: See location...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Burkina Faso
GRAS-Banfora
RECRUITING
Banfora
Contact Information
Primary
Alphonse OUEDRAOGO, MD, PhD
a.ouedraogo@gras.bf
+22670140811
Backup
Sodiomon B SIRIMA, MD, PhD, Pr
s.sirima@gras.bf
+22670200444
Time Frame
Start Date:2023-08-25
Estimated Completion Date:2024-12
Participants
Target number of participants:2390
Treatments
Subgroup 1, Household longitudinal survey of nulligravida cohort
fieldworkers will visit the households in the study area to identify and enroll women meeting the eligibility criteria. After consenting a fingerprick blood sample will be obtained for pregnancy testing and malaria blood smear, and VAR2CSA antibodies measurement. Enrolled women will be visited every trimester to check for pregnancy and malaria infection. The follow up of each participant will end upon a pregnancy test is positive or at month 9 after the enrolment.
Subgroup 2, Single timepoint evaluation for primigravidae 1rst, 2nd and 3 rd trimester
Participants will be enrolled by study staff stationed at the antenatal care clinic. Women attending the ANC visit at any gestational age will be screened and those meeting the eligibility criteria will undergo the study procedures which includes collecting demographic data, medical and pregnancy history. They will then be requested to donate a fingerprick blood sample for malaria infection and hemoglobin measurement.
Subgroup 3, Single timepoint evaluation at primigravidae delivery
participants will be recruited during any of the ANC visit as consenting process will not be feasible during the labour at delivery. They will be issued a sticker that will be affixed to the health card so that they could easily be recognized when they come for delivery.~At delivery, samples will be collected from fingerprick, cord blood and placenta for detecting malaria infection by microscopy and histopathology. Additional data will be collected on the neonate for secondary outcomes assessment, adverse birth outcomes .