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Completed

NCT Number: NCT03079388

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

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.

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Key information

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

1 Moriba Street

Pujehun, Pujehun District, Sierra Leone

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ready-to-use-supplementary food

Dietary Supplement

Specially formulated supplementary food for pregnancy

Corn-soy-blend

Dietary Supplement

Standard of care for malnutrition in pregnancy in Sierra Leone

Monthly intermittent preventive treatment of malaria during pregnancy (IPTp)

Drug

Sulfadoxine-pyrimethamine (500 mg / 25 mg) given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later.

Other names: Sulfadoxine-pyrimethamine

Standard intermittent preventive treatment of malaria during pregnancy (IPTp)

Drug

Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).

Other names: Sulfadoxine-pyrimethamine

Insecticide-treated mosquito net

Other

An insecticide-treated mosquito net at the time of enrollment into the study.

Azithromycin

Drug

Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.

Albendazole

Drug

Single dose albendazole 400mg given in the second trimester.

Bacterial vaginosis testing and treatment

Combination Product

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.

Primary outcomes

  1. Infant birth length

    Time frame: up to 40 weeks

    mean birth length of infants born to mothers in the study

Secondary outcomes

  1. Maternal weight gain

    Time frame: up to 40 weeks

    Average weekly weight gain of women in the study

  2. Proportion recovered from maternal malnutrition

    Time frame: up to 40 weeks

    proportion of women who reach mid-upper-arm circumference (MUAC) > 23 cm

  3. Premature delivery

    Time frame: up to 36 weeks

    proportion of infants born prematurely

  4. Newborn head circumference

    Time frame: up to 40 weeks

    mean head circumference of infants born to women in the study

  5. Infant birth weight

    Time frame: up to 40 weeks

    mean birth weights of infants born to mothers in the study

  6. Infant weight at 6 weeks, 3 and 6 months

    Time frame: up to 6 months

    infant ponderal growth

  7. Infant length at 6 weeks, 3 and 6 months

    Time frame: up to 6 months

    infant linear growth

  8. Infant survival at 3 and 6 months

    Time frame: up to 6 months

    survival of infants in the study

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Children's Investment Fund Foundation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 14, 2017
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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