Understanding malaria in pregnant women and its impact on pregnancy outcomes
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
This study looks at how malaria affects pregnancy in women who are pregnant for the first time to see how common the infection is and how it impacts their health and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2390 (estimated) |
| Ages | 15 Years and up |
| Sex | Female |
| Sponsor | Groupe de Recherche Action en Sante Academic / other |
| Locations | 1 site (Banfora) |
| Trial ID | NCT06162078 on ClinicalTrials.gov |
What this trial studies
This observational study aims to longitudinally assess the occurrence of pregnancy among nulligravida women and estimate the burden of malaria infection during pregnancy. It involves three subgroups: the first will track nulligravida women through household visits, collecting blood samples for pregnancy testing and malaria assessment. The second subgroup will enroll primigravidae women at antenatal care clinics for a one-time evaluation of malaria infection and hemoglobin levels. The third subgroup will identify primigravidae women during delivery to collect samples from various sources.
Who should consider this trial
Good fit: Ideal candidates include nulligravida women aged 15 years and older residing in the study area, as well as primigravidae women at various stages of pregnancy.
Not a fit: Patients who are not of childbearing potential or those who have undergone sterilization procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the relationship between malaria and pregnancy, potentially leading to improved maternal and fetal health outcomes.
How similar studies have performed: While the approach of assessing malaria burden in pregnant women is established, the specific longitudinal methodology in this context may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Banfora
- GRAS-Banfora — Banfora, Burkina Faso (Recruiting)
Study contacts
- Principal investigator: Alphonse OUEDRAOGO, MD, PhD — Groupe de Recherche Action en Sante (GRAS)
- Study coordinator: Alphonse OUEDRAOGO, MD, PhD
- Email: a.ouedraogo@gras.bf
- Phone: +22670140811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.