NCT03079388

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

Randomized Control Trial of the Use of Supplementary Food and Measures to Control Inflammation in Malnourished Pregnant Women to Improve Birth Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,489 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy
• Malnutrition in Pregnancy
• Nutrition Disorders
• Stunting

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ready-to-use-supplementary food	Specially formulated supplementary food for pregnancy
DIETARY_SUPPLEMENT	Corn-soy-blend	Standard of care for malnutrition in pregnancy in Sierra Leone
DRUG	Monthly intermittent preventive treatment of malaria during pregnancy (IPTp)	Sulfadoxine-pyrimethamine (500 mg / 25 mg) given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later.
DRUG	Standard intermittent preventive treatment of malaria during pregnancy (IPTp)	Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).
OTHER	Insecticide-treated mosquito net	An insecticide-treated mosquito net at the time of enrollment into the study.
DRUG	Azithromycin	Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.
DRUG	Albendazole	Single dose albendazole 400mg given in the second trimester.
COMBINATION_PRODUCT	Bacterial vaginosis testing and treatment	Testing for bacterial vaginosis at enrollment and again at weeks 28-34 using a rapid diagnostic test for sialidase. Those with positive tests will receive extended release metronidazole 750mg daily for 7 days.

Timeline

• Start date: 2017-02-27
• Primary completion: 2019-09-24
• Completion: 2020-02-24
• First posted: 2017-03-14
• Last updated: 2021-01-07

Locations

1 site across 1 country: Sierra Leone