Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida

NCT06162078 | Unknown

• 1 other identifier: GRAS
• Study Type: observational
• Target: 2,390
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Malaria During Pregnancy - Baby Not Yet Delivered

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Adverse birth outcomes

  9 months

• Uptake IPTp-SP (Intermittent preventive treatment of malaria in pregnancy using sulfadoxine-pyrimethamine) during the pregnancy

  9 months

Other Outcomes (3)

• Titers of VAR2CSA (a large 350-kDa protein comprising six Duffy-binding-like (DBL) domains and three larger interdomain regions) antibodies in nulliparous

  3 months

• Gametocytes presence in placental tissue

  9 months

• Prevalence of mutations among pregnancy

  9 months

Study Arms (3)

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 .

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: female nulligravida able to become pregnant for sub-group 1 and primigravidae attending to ANC or deliver
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe de Recherche Action en Sante: lead
• European Vaccine Initiative: collaborator

Study Sites (1)

GRAS-Banfora

Banfora, 10248, Burkina Faso

RECRUITING

Study Officials

• Alphonse OUEDRAOGO, MD, PhD

  Groupe de Recherche Action en Sante (GRAS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alphonse OUEDRAOGO, MD, PhD

CONTACT

+22670140811; a.ouedraogo@gras.bf

Sodiomon B SIRIMA, MD, PhD, Pr

CONTACT

+22670200444; s.sirima@gras.bf

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: December 8, 2023
• Study Start: August 25, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 19, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: data available
• Access Criteria: publication

Locations

BU (1)