Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)

• Status: Completed
• Trial end date: 2020-02-24
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Pregnant women and consenting to study participation

• Fundal height not greater than 32 cm

• Mid-upper arm circumference ≤23 cm

• Planning to reside in the study area during pregnancy and 6 months post partum

• Attending 1 of the 40 antenatal clinic sites

Exclusion Criteria:

• < 16 years of age without adult willing to consent

• Known pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension