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

Autor: Patrick Lasowski, Meghan Callaghan-Gillespie, Peggy Papathakis, Jacklyn Weber, Mark J. Manary, Kristie Smith, Aminata Shamit Koroma, David Taylor Hendrixson, Per Ole Iversen
Rok vydání: 2021
Předmět:
Pediatrics
Physiology
Maternal Health
Vaginal Diseases
Psychological intervention
Azithromycin
Weight Gain
Families
Labor and Delivery
Pregnancy
Medicine and Health Sciences
Medicine
Prospective Studies
Children
Pregnancy Outcome
Gestational age
Obstetrics and Gynecology
Prenatal Care
General Medicine
Anti-Bacterial Agents
Physiological Parameters
Female
Food Assistance
Infants
Research Article
Adult
medicine.medical_specialty
Adolescent
Birth weight
Antiprotozoal Agents
Context (language use)
Albendazole
Sierra leone
Sierra Leone
Young Adult
Humans
Nutrition
Infection Control
Intention-to-treat analysis
business.industry
Malnutrition
Body Weight
Biology and Life Sciences
Neonates
medicine.disease
Infant mortality
Diet
Malaria
Pregnancy Complications
Age Groups
Food
People and Places
Birth
Women's Health
Dysbiosis
Population Groupings
business
Developmental Biology
Zdroj: PLoS Medicine
PLoS Medicine, Vol 18, Iss 9, p e1003618 (2021)
ISSN: 1549-1277
Popis: Background Innovations for undernourished pregnant women that improve newborn survival and anthropometry are needed to achieve the Sustainable Development Goals 1 and 3. This study tested the hypothesis that a combination of a nutritious supplementary food and several proven chemotherapeutic interventions to control common infections would increase newborn weight and length in undernourished pregnant women. Methods and findings This was a prospective, randomized, controlled clinical effectiveness trial of a ready-to-use supplementary food (RUSF) plus anti-infective therapies compared to standard therapy in undernourished pregnant women in rural Sierra Leone. Women with a mid-upper arm circumference (MUAC) ≤23.0 cm presenting for antenatal care at one of 43 government health clinics in Western Rural Area and Pujehun districts were eligible for participation. Standard of care included a blended corn/soy flour and intermittent preventive treatment for malaria in pregnancy (IPTp). The intervention replaced the blended flour with RUSF and added azithromycin and testing and treatment for vaginal dysbiosis. Since the study involved different foods and testing procedures for the intervention and control groups, no one except the authors conducting the data analyses were blinded. The primary outcome was birth length. Secondary outcomes included maternal weight gain, birth weight, and neonatal survival. Follow-up continued until 6 months postpartum. Modified intention to treat analyses was undertaken. Participants were enrolled and followed up from February 2017 until February 2020. Of the 1,489 women enrolled, 752 were allocated to the intervention and 737 to the standard of care. The median age of these women was 19.5 years, of which 42% were primigravid. Twenty-nine women receiving the intervention and 42 women receiving the standard of care were lost to follow-up before pregnancy outcomes were obtained. There were 687 singleton live births in the intervention group and 657 in the standard of care group. Newborns receiving the intervention were 0.3 cm longer (95% confidence interval (CI) 0.09 to 0.6; p = 0.007) and weighed 70 g more (95% CI 20 to 120; p = 0.005) than those receiving the standard of care. Those women receiving the intervention had greater weekly weight gain (mean difference 40 g; 95% CI 9.70 to 71.0, p = 0.010) than those receiving the standard of care. There were fewer neonatal deaths in the intervention (n = 13; 1.9%) than in the standard of care (n = 28; 4.3%) group (difference 2.4%; 95% CI 0.3 to 4.4), (HR 0.62 95% CI 0.41 to 0.94, p = 0.026). No differences in adverse events or symptoms between the groups was found, and no serious adverse events occurred. Key limitations of the study are lack of gestational age estimates and unblinded administration of the intervention. Conclusions In this study, we observed that the addition of RUSF, azithromycin, more frequent IPTp, and testing/treatment for vaginal dysbiosis in undernourished pregnant women resulted in modest improvements in anthropometric status of mother and child at birth, and a reduction in neonatal death. Implementation of this combined intervention in rural, equatorial Africa may well be an important, practical measure to reduce infant mortality in this context. Trial registration ClinicalTrials.gov NCT03079388.
In a randomized trial, D. Taylor Hendrixson and colleagues investigate the effect of an intervention combining supplementary food and anti-infection medications on birth outcomes.
Author summary Why was this study done? Undernutrition in pregnancy increases the risk of adverse pregnancy outcomes. Interventions for undernutrition in pregnancy have been traditionally based on nutritional supplementation with modest improvement. Pregnant women with undernutrition are at increased risk of infection and inflammation. The effect of bundling nutritional and anti-infective interventions for undernutrition in pregnancy has not been implemented in a clinical trial. What did the researchers do and find? We performed a randomized, controlled clinical trial of a ready-to-use supplementary food (RUSF) plus anti-infective therapies compared to standard therapy for undernourished pregnant women in rural Sierra Leone. Infants born to women receiving the intervention had longer birth lengths, larger weights, and larger mid-upper arm circumferences (MUACs) when compared to infants born to mothers receiving the standard of care. Mortality was decreased among infants born to mothers receiving the intervention through 6 months of life. Women receiving the intervention had increased weight gain and greater recovery from undernutrition when compared to women receiving the standard of care. What do these findings mean? Bundling nutritional and anti-infective interventions for the treatment of undernourished pregnant women improved infant birth size, growth, and survival through 6 months of life. Futher studies are required to determine the effect of the intervention on preterm birth.
Databáze: OpenAIRE
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