Pregnancy, Malnutrition in Pregnancy, Nutrition Disorders, Stunting
Conditions
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.
Interventions
DIETARY_SUPPLEMENTReady-to-use-supplementary food
Specially formulated supplementary food for pregnancy
DIETARY_SUPPLEMENTCorn-soy-blend
Standard of care for malnutrition in pregnancy in Sierra Leone
DRUGMonthly 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.
DRUGStandard intermittent preventive treatment of malaria during pregnancy (IPTp)
Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).
An insecticide-treated mosquito net at the time of enrollment into the study.
DRUGAzithromycin
Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.
DRUGAlbendazole
Single dose albendazole 400mg given in the second trimester.
COMBINATION_PRODUCTBacterial 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.
Sponsors
The Children's Investment Fund Foundation
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant birth length | up to 40 weeks | mean birth length of infants born to mothers in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion recovered from maternal malnutrition | up to 40 weeks | proportion of women who reach mid-upper-arm circumference (MUAC) \> 23 cm |
| Premature delivery | up to 36 weeks | proportion of infants born prematurely |
| Newborn head circumference | up to 40 weeks | mean head circumference of infants born to women in the study |
| Maternal weight gain | up to 40 weeks | Average weekly weight gain of women in the study |
| Infant weight at 6 weeks, 3 and 6 months | up to 6 months | infant ponderal growth |
| Infant length at 6 weeks, 3 and 6 months | up to 6 months | infant linear growth |
| Infant survival at 3 and 6 months | up to 6 months | survival of infants in the study |
| Infant birth weight | up to 40 weeks | mean birth weights of infants born to mothers in the study |
Countries
Sierra Leone
Outcome results
None listed