Clinical trial NCT06162078: Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maternal Malaria During Pregnancy - Baby Not Yet Delivered
Lead sponsor: Groupe de Recherche Action en Sante
Sponsor class: OTHER
Collaborators: name: European Vaccine Initiative
First posted: 2023-12-08
Enrollment: 2390
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For subgroup 1:

Fieldworkers will visit the households in the study area to identify and enroll women meeting the eligibility criteria.

For subgroup 2:

Paticipants 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 enrolled.

For Subgroup 3:

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.

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 the course of the pregnancy till delivery.

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 involve in a nulligravida cohort aged ≥ 15 years. After consenting a fingerprick blood sample will be obtained for pregnancy testing, 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.

Participants to subgroup 2 will be enrolled primigravidae aged ≥ 15 years 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. This will be a single timepoint evaluation.

Subgroup 3 participants will be recruited primigravidae aged ≥ 15 years 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.

Eligibility 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.

Primary outcomes:
measure: Proportion of nulliparous with positive urine test
timeFrame: 9 months
measure: P. falciparum infection in nulliparous attending the antenatal care visit
timeFrame: 9 months
measure: Moderate and severe anemia during the last antenatal care visit
timeFrame: 9 months
measure: P. falciparum infection at delivery
timeFrame: 9 months
measure: Placental infection
timeFrame: 9 months
Secondary outcomes:
measure: Adverse birth outcomes
timeFrame: 9 months
measure: Uptake IPTp-SP (Intermittent preventive treatment of malaria in pregnancy using sulfadoxine-pyrimethamine) during the pregnancy
timeFrame: 9 months
Other outcomes:
measure: Titers of VAR2CSA (a large 350-kDa protein comprising six Duffy-binding-like (DBL) domains and three larger interdomain regions) antibodies in nulliparous
timeFrame: 3 months
measure: Gametocytes presence in placental tissue
timeFrame: 9 months
measure: Prevalence of mutations among pregnancy
timeFrame: 9 months
Locations:
city: Banfora
country: Burkina Faso
facility: GRAS-Banfora
Study officials:
affiliation: Groupe de Recherche Action en Sante (GRAS)
name: Alphonse OUEDRAOGO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: