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

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

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.

Sponsors & Collaborators

• The Children's Investment Fund Foundation

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Mark J Manary, MD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-27

Primary Completion

2019-09-24

Completion

2020-02-24

Countries

• Sierra Leone

Study Locations