Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study: protocol of a pragmatic clinical effectiveness study to improve birth outcomes in Ethiopia

Abstract

IntroductionThe WHO Nutrition Target aims to reduce the global prevalence of low birth weight by 30% by the year 2025. The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study will test the impact of packages of pregnancy interventions to enhance maternal nutrition and infection management on birth outcomes in rural Ethiopia.Methods and analysisENAT is a pragmatic, open-label, 2×2 factorial, randomised clinical effectiveness study implemented in 12 rural health centres in Amhara, Ethiopia. Eligible pregnant women presenting at antenatal care (ANC) visits at <24 weeks gestation are enrolled (n=2400). ANC quality is strengthened across all centres. Health centres are randomised to receive an enhanced nutrition package (ENP) or standard nutrition care, and within each health centre, individual women are randomised to receive an enhanced infection management package (EIMP) or standard infection care. At ENP centres, women receive a regular supply of adequately iodised salt and iron–folate (IFA), enhanced nutrition counselling and those with mid-upper arm circumference of <23 cm receive a micronutrient fortified balanced energy protein supplement (corn soya blend) until delivery. In standard nutrition centres, women receive routine counselling and IFA. EIMP women have additional screening/treatment for urinary and sexual/reproductive tract infections and intensive deworming. Non-EIMP women are managed syndromically per Ministry of Health Guidelines. Participants are followed until 1-month post partum, and a subset until 6 months. The primary study outcomes are newborn weight and length measured at <72 hours of age. Secondary outcomes include preterm birth, low birth weight and stillbirth rates; newborn head circumference; infant weight and length for age z-scores at birth; maternal anaemia; and weight gain during pregnancy.Ethics and disseminationENAT is approved by the Institutional Review Boards of Addis Continental Institute of Public Health (001-A1-2019) and Mass General Brigham (2018P002479). Results will be disseminated to local and international stakeholders.Registration numberISRCTN15116516.

Nutritious Supplemental Foods for Pregnant Women from Food Insecure Settings: Types, Nutritional Composition, and Relationships to Health Outcomes

“…The MISAME-III and MINT trials use a factorial design to assess the impact of a fortified BEP (produced by the Nutriset company) in pregnancy alone, in lactation alone, and in pregnancy and lactation together [ [48] , [49] , [50] ]. The ENAT trial is testing the effect of IFA, iodized salt, enriched Corn Soya Blend type of fortified BEP (a World Food Program product called Super Cereal given only to women with MUAC of <23 cm), and infection management to pregnant women only [ 51 ]. The MumtaPW trial investigates the effect of fortified BEP (a World Food Program product called Mumta that provides high-energy biscuits) in combination with infection prophylaxis (2000 mg of Azithromycin in infants) or a choline and nicotinamide (i.e., niacin) supplement given to pregnant women only [ 52 ].…”

Dietary Perspectives and Practices during Pregnancy in Rural Amhara Region of Ethiopia: An Exploratory Qualitative Study

“…This study was conducted to inform the design of a maternal nutrition program for an intervention study [ 17 ]. Several key considerations for intervention designed emerged from these data.…”

“…This formative qualitative study was conducted from October to November 2018 to inform the design of interventions for the “Enhancing Antenatal Nutrition and Infection Treatment for Maternal and Child Health” study ( https://www.isrctn.com/ISRCTN15116516 ) [ 17 ]. The overall aim of the main study was to determine the impact of a combined package of antenatal care (ANC) interventions to enhance maternal nutritional status and manage maternal pregnancy infections on newborn size at birth [ 17 ]. This qualitative research was performed before the intervention study to inform the design of the nutrition intervention package and the nutrition counseling.…”

Targeting strategies of antenatal balanced energy and protein supplementation in Addis Ababa, Ethiopia: study protocol for a randomized effectiveness study

“…The GWG Pooling Project has accumulated a wealth of data on longitudinal gestational weights, including pre-pregnancy weights from some studies and early-pregnancy weights from many studies [ 28 , 29 ]. We conducted external validation of the tool using internal data from Ethiopia [ 30 ].…”