Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)
NCT ID: NCT03079388
Last Updated: 2021-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1489 participants
INTERVENTIONAL
2017-02-27
2020-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ready-to-use supplementary food + anti-infective bundle
The women randomized to this arm will receive a ready-to-use-supplementary food (RUSF) designed specifically for pregnancy. The RUSF will provide a total of 520 kcal, 18 g protein, and 200% of recommended daily allowance (RDA) for most micronutrients during pregnancy. The supplement is also optimized to provide excellent protein quality and optimal polyunsaturated fatty acid composition. These women will receive 5 anti-infective interventions: 1) insecticide-treated mosquito net, 2) monthly intermittent preventive treatment of malaria during pregnancy (IPTp) 3) azithromycin at the second and third trimester 4) albendazole given in second trimester, and 5) bacterial vaginosis testing and treatment at enrollment and again at weeks 28-34
Ready-to-use-supplementary food
Specially formulated supplementary food for pregnancy
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.
Insecticide-treated mosquito net
An insecticide-treated mosquito net at the time of enrollment into the study.
Azithromycin
Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.
Albendazole
Single dose albendazole 400mg given in the second trimester.
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.
Corn-soy-blend
The women randomized to this arm will receive the standard of care for Sierra Leone. The treatment provided to women in this group includes 3.5 kg super cereal with 350 g vegetable oil every two weeks. This provides 250 mg portion/day of the super cereal and 25g oil/day for the mother. Women will receive the food for the duration of their pregnancy. These women will receive the current recommendations of the government of Sierra Leone, which includes standard intermittent preventive treatment of malaria during pregnancy (IPTp) of 2 doses of sulfadoxine/ pyrimethamine, iron and folic acid supplement with a goal of 90 pills/pregnancy, an insecticide-treated mosquito net, and albendazole for deworming in the second trimester.
Corn-soy-blend
Standard of care for malnutrition in pregnancy in Sierra Leone
Standard intermittent preventive treatment of malaria during pregnancy (IPTp)
Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).
Insecticide-treated mosquito net
An insecticide-treated mosquito net at the time of enrollment into the study.
Albendazole
Single dose albendazole 400mg given in the second trimester.
Interventions
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Ready-to-use-supplementary food
Specially formulated supplementary food for pregnancy
Corn-soy-blend
Standard of care for malnutrition in pregnancy in Sierra Leone
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.
Standard intermittent preventive treatment of malaria during pregnancy (IPTp)
Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).
Insecticide-treated mosquito net
An insecticide-treated mosquito net at the time of enrollment into the study.
Azithromycin
Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.
Albendazole
Single dose albendazole 400mg given in the second trimester.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Known pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
14 Years
FEMALE
No
Sponsors
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The Children's Investment Fund Foundation
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Mark J Manary, MD
Role: STUDY_CHAIR
Washington University School of Medicine
Locations
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1 Moriba Street
Pujehun, Pujehun District, Sierra Leone
Countries
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References
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Hendrixson DT, Lasowski PN, Koroma AS, Manary MJ. Newborn Mid-Upper Arm Circumference Identifies Low-Birth Weight and Vulnerable Infants: A Secondary Analysis. Curr Dev Nutr. 2022 Sep 12;6(10):nzac138. doi: 10.1093/cdn/nzac138. eCollection 2022 Oct.
Hendrixson DT, Smith K, Lasowski P, Callaghan-Gillespie M, Weber J, Papathakis P, Iversen PO, Koroma AS, Manary MJ. A novel intervention combining supplementary food and infection control measures to improve birth outcomes in undernourished pregnant women in Sierra Leone: A randomized, controlled clinical effectiveness trial. PLoS Med. 2021 Sep 28;18(9):e1003618. doi: 10.1371/journal.pmed.1003618. eCollection 2021 Sep.
Hendrixson DT, Koroma AS, Callaghan-Gillespie M, Weber J, Papathakis P, Manary MJ. Use of a novel supplementary food and measures to control inflammation in malnourished pregnant women in Sierra Leone to improve birth outcomes: study protocol for a prospective, randomized, controlled clinical effectiveness trial. BMC Nutr. 2018 Apr 2;4:15. doi: 10.1186/s40795-018-0218-y. eCollection 2018.
Other Identifiers
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201611119
Identifier Type: -
Identifier Source: org_study_id
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