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

The Washington University

Status: Completed

Conditions: Nutrition Disorders; Stunting; Malnutrition in Pregnancy; Pregnancy

Treatments: Drug: Azithromycin; Drug: Standard intermittent preventive treatment of malaria during pregnancy (IPTp); Dietary Supplement: Ready-to-use-supplementary food; Drug: Monthly intermittent preventive treatment of malaria during pregnancy (IPTp); Dietary Supplement: Corn-soy-blend; Drug: Albendazole; Other: Insecticide-treated mosquito net; Combination Product: Bacterial vaginosis testing and treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03079388

201611119

Details and patient eligibility

About

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.

Enrollment: 1,489 patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,489 participants in 2 patient groups

Ready-to-use supplementary food + anti-infective bundle

Experimental group

Description:

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

Treatment:

Other: Insecticide-treated mosquito net

Drug: Monthly intermittent preventive treatment of malaria during pregnancy (IPTp)

Combination Product: Bacterial vaginosis testing and treatment

Dietary Supplement: Ready-to-use-supplementary food

Drug: Albendazole

Drug: Azithromycin

Corn-soy-blend

Active Comparator group

Description:

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.

Treatment:

Other: Insecticide-treated mosquito net

Dietary Supplement: Corn-soy-blend

Drug: Standard intermittent preventive treatment of malaria during pregnancy (IPTp)

Drug: Albendazole