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Randomized Control Trial of the Use of Supplementary Food and Measures to Control Inflammation in Malnourished Pregnant Women to Improve Birth Outcomes
Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development. Poor women in the developing world are at heightened risk of malnutrition due to inadequate dietary intake and are subject to transmission of a number of infections including malaria, intestinal helminths, and genitourinary infections. Food interventions for malnutrition may be less effective under conditions with excessive inflammation and infection, and especially so during pregnancy. Without specifically addressing treatment for infections, undernourished mothers may be less responsive to nutritional interventions. The benefits of treating both malnutrition and common infections simultaneously remain largely unstudied. This study tests the hypothesis that malnourished pregnant women receiving 100 grams per day of a specially formulated ready-to-use supplementary food in addition to a combination of 5 anti-infective interventions will have greater weight gain in pregnancy and deliver larger, longer infants than women receiving the standard of care. The outcome of the pregnancy and maternal nutritional status will be followed until 6 months after delivery.
Age
14 - No limit years
Sex
FEMALE
Healthy Volunteers
No
1 Moriba Street
Pujehun, Pujehun District, Sierra Leone
Start Date
February 27, 2017
Primary Completion Date
September 24, 2019
Completion Date
February 24, 2020
Last Updated
January 7, 2021
1,489
ACTUAL participants
Ready-to-use-supplementary food
DIETARY_SUPPLEMENT
Corn-soy-blend
DIETARY_SUPPLEMENT
Monthly intermittent preventive treatment of malaria during pregnancy (IPTp)
DRUG
Standard intermittent preventive treatment of malaria during pregnancy (IPTp)
DRUG
Insecticide-treated mosquito net
OTHER
Azithromycin
DRUG
Albendazole
DRUG
Bacterial vaginosis testing and treatment
COMBINATION_PRODUCT
Lead Sponsor
Washington University School of Medicine
Collaborators
NCT06768060
NCT07462065
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06273683