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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079388
• Other study ID #: 201611119
• Status: Completed
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: February 24, 2020

Study information

• Verified date: January 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1489
• Est. completion date: February 24, 2020
• Est. primary completion date: September 24, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Malnutrition in Pregnancy
• Nutrition Disorders
• Pregnancy
• Stunting

Intervention

Dietary Supplement:
• Ready-to-use-supplementary food
Specially formulated supplementary food for pregnancy
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Sierra Leone	1 Moriba Street	Pujehun	Pujehun District

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	The Children's Investment Fund Foundation

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant birth length	mean birth length of infants born to mothers in the study	up to 40 weeks
Secondary	Maternal weight gain	Average weekly weight gain of women in the study	up to 40 weeks
Secondary	Proportion recovered from maternal malnutrition	proportion of women who reach mid-upper-arm circumference (MUAC) > 23 cm	up to 40 weeks
Secondary	Premature delivery	proportion of infants born prematurely	up to 36 weeks
Secondary	Newborn head circumference	mean head circumference of infants born to women in the study	up to 40 weeks
Secondary	Infant birth weight	mean birth weights of infants born to mothers in the study	up to 40 weeks
Secondary	Infant weight at 6 weeks, 3 and 6 months	infant ponderal growth	up to 6 months
Secondary	Infant length at 6 weeks, 3 and 6 months	infant linear growth	up to 6 months
Secondary	Infant survival at 3 and 6 months	survival of infants in the study	up to 6 months