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

NACompletedINTERVENTIONAL
Enrollment

1,489

Participants

Timeline

Start Date

February 27, 2017

Primary Completion Date

September 24, 2019

Study Completion Date

February 24, 2020

Conditions
PregnancyMalnutrition in PregnancyNutrition DisordersStunting
Interventions
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.

Trial Locations (1)

Unknown

1 Moriba Street, Pujehun

All Listed Sponsors
collaborator

The Children's Investment Fund Foundation

OTHER

lead

Washington University School of Medicine

OTHER

NCT03079388 - Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi) | Biotech Hunter | Biotech Hunter