Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida (EPI-PAM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Maternal Malaria During Pregnancy - Baby Not Yet Delivered

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.

• Study Type: Observational
• Enrollment (Estimated): 2390

Contacts and Locations

• Study Contact: Name: Alphonse OUEDRAOGO, MD, PhD; Phone Number: +22670140811; Email: a.ouedraogo@gras.bf
• Study Contact Backup: Name: Sodiomon B SIRIMA, MD, PhD, Pr; Phone Number: +22670200444; Email: s.sirima@gras.bf

Study Locations

• Burkina Faso
  • Banfora, Burkina Faso, 10248
    • Recruiting
    • GRAS-Banfora
    • Contact: Alphonse Ouedraogo, PhD; Phone Number: +22670140811; Email: a.ouedraogo@gras.bf
    • Contact: Jean Baptiste Yaro, PhD; Phone Number: +22670718842; Email: j.yaro@gras.bf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of nulliparous with positive urine test	Proportion of nulliparous with positive urine pregnancy test at 3 months, 6 months and 9 months post enrolment	9 months
P. falciparum infection in nulliparous attending the antenatal care visit	Prevalence of P. falciparum infection by microscopy and PCR (polymerase chain reaction) in nulliparous attending the antenatal care visit at the local health care facility	9 months
Moderate and severe anemia during the last antenatal care visit	Proportion of pregnant women with moderate and severe anemia during the last antenatal care visit at the local health care facility	9 months
P. falciparum infection at delivery	Prevalence of parasitemia at delivery (maternal and cord blood) by microscopy	9 months
Placental infection	Proportion of women at delivery with histopathologically confirmed placental infection	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse birth outcomes	Prevalence of adverse birth outcomes (spontaneous abortion, stillbirth, low birth weight (<2,500 g), preterm delivery (<37 weeks))	9 months
Uptake IPTp-SP (Intermittent preventive treatment of malaria in pregnancy using sulfadoxine-pyrimethamine) during the pregnancy	Proportion of pregnant women receiving one, two, three and ≥ 3 doses of IPT-SP during the pregnancy	9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Titers of VAR2CSA (a large 350-kDa protein comprising six Duffy-binding-like (DBL) domains and three larger interdomain regions) antibodies in nulliparous	Geometric mean titers of VAR2CSA antibodies at enrolment of nulliparous	3 months
Gametocytes presence in placental tissue	Gametocytes prevalence in placental tissue	9 months
Prevalence of mutations among pregnancy	Prevalence of dhps K540E, dhps A581G and dhfr I164L mutations (Markers of sulfadoxine-pyrimethamine resistance)	9 months

Collaborators and Investigators

• Sponsor: Groupe de Recherche Action en Sante
• Collaborators: European Vaccine Initiative
• Investigators: Principal Investigator: Alphonse OUEDRAOGO, MD, PhD, Groupe de Recherche Action en Sante (GRAS)

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Mosquito-Borne Diseases; Malaria
• Other Study ID Numbers: GRAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: data available
• IPD Sharing Access Criteria: publication
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No