Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02974608 |
| Other study ID # |
999917018 |
| Secondary ID |
17-I-N018 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2017 |
| Est. completion date |
April 21, 2022 |
Study information
| Verified date |
March 21, 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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...
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.
