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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03079388
Other study ID # 201611119
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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