Clinical trial NCT03079388: Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)
Official title: Randomized Control Trial of the Use of Supplementary Food and Measures to Control Inflammation in Malnourished Pregnant Women to Improve Birth Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Malnutrition in Pregnancy
Nutrition Disorders
Stunting
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Children's Investment Fund Foundation
First posted: 2017-03-14
Enrollment: 1489
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Infant birth length
timeFrame: up to 40 weeks
Secondary outcomes:
measure: Maternal weight gain
timeFrame: up to 40 weeks
measure: Proportion recovered from maternal malnutrition
timeFrame: up to 40 weeks
measure: Premature delivery
timeFrame: up to 36 weeks
measure: Newborn head circumference
timeFrame: up to 40 weeks
measure: Infant birth weight
timeFrame: up to 40 weeks
measure: Infant weight at 6 weeks, 3 and 6 months
timeFrame: up to 6 months
measure: Infant length at 6 weeks, 3 and 6 months
timeFrame: up to 6 months
measure: Infant survival at 3 and 6 months
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Pujehun
country: Sierra Leone
facility: 1 Moriba Street
state: Pujehun District
Study officials:
affiliation: Washington University School of Medicine
name: Mark J Manary, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.