1 Moriba Street
Pujehun, Pujehun District, Sierra Leone
NCT Number: NCT03079388
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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Notify Me14 year and older
Female
Interventional
Not applicable
Pujehun, Pujehun District, Sierra Leone
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specially formulated supplementary food for pregnancy
Standard of care for malnutrition in pregnancy in Sierra Leone
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 of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).
Other names: Sulfadoxine-pyrimethamine
An insecticide-treated mosquito net at the time of enrollment into the study.
Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.
Single dose albendazole 400mg given in the second trimester.
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.
Time frame: up to 40 weeks
mean birth length of infants born to mothers in the study
Time frame: up to 40 weeks
Average weekly weight gain of women in the study
Time frame: up to 40 weeks
proportion of women who reach mid-upper-arm circumference (MUAC) > 23 cm
Time frame: up to 36 weeks
proportion of infants born prematurely
Time frame: up to 40 weeks
mean head circumference of infants born to women in the study
Time frame: up to 40 weeks
mean birth weights of infants born to mothers in the study
Time frame: up to 6 months
infant ponderal growth
Time frame: up to 6 months
infant linear growth
Time frame: up to 6 months
survival of infants in the study
Washington University School of Medicine
Other
Randomized Control Trial of the Use of Supplementary Food and Measures to Control Inflammation in Malnourished Pregnant Women to Improve Birth Outcomes
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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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