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

Maternal Malaria During Pregnancy - Baby Not Yet Delivered Clinical Trial

— EPI-PAM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162078
• Other study ID #: GRAS
• Status: Recruiting
• Start date: August 25, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Groupe de Recherche Action en Sante
• Contact: Alphonse OUEDRAOGO, MD, PhD
• Phone: +22670140811
• Email: a.ouedraogo[@]gras.bf
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2390
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malaria
• Maternal Malaria During Pregnancy - Baby Not Yet Delivered

Locations

Country	Name	City	State
Burkina Faso	GRAS-Banfora	Banfora

Sponsors (2)

Lead Sponsor	Collaborator
Groupe de Recherche Action en Sante	European Vaccine Initiative

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Gametocytes presence in placental tissue	Gametocytes prevalence in placental tissue	9 months
Other	Prevalence of mutations among pregnancy	Prevalence of dhps K540E, dhps A581G and dhfr I164L mutations (Markers of sulfadoxine-pyrimethamine resistance)	9 months
Primary	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
Primary	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
Primary	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
Primary	P. falciparum infection at delivery	Prevalence of parasitemia at delivery (maternal and cord blood) by microscopy	9 months
Primary	Placental infection	Proportion of women at delivery with histopathologically confirmed placental infection	9 months
Secondary	Adverse birth outcomes	Prevalence of adverse birth outcomes (spontaneous abortion, stillbirth, low birth weight (<2,500 g), preterm delivery (<37 weeks))	9 months
Secondary	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