Impact of Malaria on Pregnant Women in Ouelessebougou, Mali

NCT02974608 | Completed

• 2 other identifiers: 99991701817-I-N018
• Study Type: observational
• Target: 7,691
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa, malaria continues to be the main cause of death in young children and pregnant women. Researchers want to find out more about how malaria affects pregnant women and their babies. Objectives: To study the rate of miscarriage and stillbirth during the second and third trimesters among women in a certain district in Mali. To study rates of malaria infection over time among pregnant women and children in this area. Eligibility: Pregnant women of any age and pregnancy stage and their newborns. They must live in Ouelessebougou, Mali. Children up to 10 years old who live there. Design: Information about the study will be shared at community meetings, during visits to the health centers, and during census updates. Participants will read and sign a consent form. Pregnant women will be screened to see if they are eligible. They may have a urine test. They may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take pictures of the body. Women will be enrolled in the study after they have their babies. Participants may have a physical exam. Some participants will provide a finger/heel prick blood sample. Participants will complete a questionnaire. They will be asked about: Medical history Antimalarial and other interventions Socioeconomic status Their pregnancy Previous pregnancies Health of their newborn...

Conditions

Malaria

Keywords

Placental; Fetal Loss; Observational; Antenatal; Infection; Natural History

Outcome Measures

Primary Outcomes (2)

• Prevalence of malaria infection

  Rates of malaria infections

  Semi-annual

• Assess the rate of fetal loss during the 2nd and 3rd trimesters

  Rates of fetal losses

  Annual

Secondary Outcomes (2)

• Assess the prevalence rate of SP resistant parasites

  Annual

• Assess the rate of pre-term and low birth weight deliveries

  Annual

Study Arms (3)

Children 0-10 years

Children living in selected villages surrounding the district of Ouelessebougou

Pregnant Women + Newborns

Pregnant women of any age and their newborn children

Women of Child Bearing Age Potential

Non-pregnant women of child-bearing age

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population from which the cohorts will be selected live in selected villages surrounding the districts of Ouelessebougou, Mali

You may qualify if:

• A study participant must satisfy the following criteria to be enrolled in this study:
• Pregnant women and their newborn cohort: Pregnant women of any age and pregnancy stage and their newborns residing in the study area
• women of child-bearing age cohort: women who are not under contraception or breastfeeding for less than 12 months and planning to become pregnant, and their newborn once they become pregnant
• Children between the ages of 0-10 years residing in the study area
• The study participant or parent/guardian understands the study and is able to provide informed consent for themselves and/or their child.

You may not qualify if:

• Temporary residence in the study area
• Conditions that in the judgment of the investigator could impair the ability of the participants to understand the study or comply with the study procedures.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Ouelessebougou Clinical Research Center (Malaria Research and Training Center)

Bamako, Mali

Location

MeSH Terms

Conditions

Malaria; Infections

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Michal Fried, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 28, 2016
• Study Start: February 15, 2017
• Primary Completion: October 20, 2021
• Study Completion: April 21, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03-21

Locations

MA (1)