Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)
Status:
Completed
Trial end date:
2020-02-24
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Washington University School of Medicine
Collaborator:
The Children's Investment Fund Foundation
Treatments:
Albendazole Anti-Infective Agents Azithromycin Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine