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Impact of Malaria on Pregnant Women in Ouelessebougou, Mali

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ClinicalTrials.gov Identifier: NCT02974608
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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...


Condition or disease
Malaria

Detailed Description:

Placental malaria (PM) leads to poor outcomes for pregnant women and their babies, and is caused by Plasmodium falciparum sequestration in the intervillous spaces of the placenta and ensuing inflammation. Severe maternal anemia, low birth weight (LBW) delivery and fetal loss are common sequelae. Malaria-related LBW alone is estimated to cause 62,000-363,000 infant deaths in Africa each year. To reduce poor pregnancy outcomes associated with malaria infection, WHO recommends monthly anti-malarial treatment with sulfadoxine pyrimethamine (SP) during the second and third trimester and the use of insecticide-treated bed nets. However, in East and Southern Africa, SP has lost its efficacy due to the spread of drug-resistant parasites. Therefore, an effective vaccine for PM is needed. Although the ideal vaccine will be given to adolescent girls prior to becoming pregnant, at this early stage of pregnancy malaria vaccine development, it is unknown if a boosting dose may be needed during pregnancy.

Before testing new interventions to improve pregnancy outcomes, it is important to obtain baseline information on pregnancy outcomes in the target population. In our recent longitudinal study of 1,885 pregnant women in Mali, in which women were closely followed during pregnancy (including malaria prevention and treatment), 2.9%, 2.4% and 6% of pregnancies ended in miscarriage, stillbirth, and preterm delivery, respectively.

The primary goal of the study is to assess pregnancy outcomes in women in the community with access to the WHO recommended standard of care. In the first part of the study, all women presenting for an antenatal visit at Ouelessebougou health centers will be recruited into the study. In the second part of the study, non-pregnant women will be enrolled and followed to capture data on pregnancy outcomes including early pregnancy losses. Pregnancy outcome information will be collected after the birth of the child or after pregnancy termination (i.e. miscarriage/stillbirth). Primary and secondary endpoints will be analyzed using appropriate statistical methods, including possible confounders, to determine the prevalence and factors associated with poor pregnancy outcomes.

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Study Type : Observational
Estimated Enrollment : 11000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Demographic Surveillance to Monitor Impact of Malaria on Pregnant Women in Ouelessebougou, Mali
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort
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



Primary Outcome Measures :
  1. Assess the rate of fetal loss during the 2nd and 3rd trimesters [ Time Frame: Annual ]
    Rate of fetal losses

  2. Prevalence of malaria infection [ Time Frame: Semi-annual ]
    Rates of malaria infections


Secondary Outcome Measures :
  1. Assess the prevalence rate of SP resistant parasites [ Time Frame: Annual ]
    Rate of SP resistant parasites (in vivo and molecular markers)

  2. Assess the rate of pre-term and low birth weight deliveries [ Time Frame: Annual ]
    Number of pre-term deliveries, low birthweight deliveries, neonatal mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria
  • INCLUSION CRITERIA:

A study participant must satisfy the following criteria to be enrolled in this study:

  1. Pregnant women and their newborn cohort: Pregnant women of any age and pregnancy stage and their newborns residing in the study area
  2. 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
  3. Children between the ages of 0-10 years residing in the study area
  4. The study participant or parent/guardian understands the study and is able to provide informed consent for themselves and/or their child.

EXCLUSION CRITERIA:

  1. Temporary residence in the study area
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974608


Contacts
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Contact: Michal Fried, Ph.D. (301) 402-0763 michal.fried@nih.gov

Locations
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Mali
Ouelessebougou Clinical Research Center (Malaria Research and Training Center) Recruiting
Bamako, Mali
Contact: Almahamadou Mahamar    (223) 762-3250 ext 2    almahamar@icermali.org   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Michal Fried, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)

Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02974608    
Other Study ID Numbers: 999917018
17-I-N018
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 17, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Placental
Fetal Loss
Observational
Antenatal
Infection
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases