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

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Study Justification:
The ENAT study aims to address the global target set by the World Health Organization (WHO) to reduce the prevalence of low birth weight by 30% by 2025. This study specifically focuses on improving birth outcomes in rural Ethiopia, where there are high rates of neonatal mortality, low birth weight, and maternal mortality. By testing the impact of enhanced nutrition and infection management interventions during pregnancy, the study aims to provide evidence-based strategies to improve birth outcomes and reduce the burden of maternal and neonatal health issues.
Highlights:
1. Pragmatic clinical effectiveness study: The ENAT study is a pragmatic, open-label, randomized clinical effectiveness study conducted in 12 rural health centers in Amhara, Ethiopia. This design allows for the evaluation of interventions in real-world settings and provides valuable insights into their effectiveness in improving birth outcomes.
2. Enhanced nutrition package (ENP): Women in the ENP group receive a regular supply of adequately iodized salt and iron-folate supplements, enhanced nutrition counseling, and a micronutrient fortified balanced energy protein supplement. This comprehensive approach aims to address nutritional deficiencies and promote healthy weight gain during pregnancy.
3. Enhanced infection management package (EIMP): Women in the EIMP group receive additional screening and treatment for urinary and sexual/reproductive tract infections, as well as intensive deworming. This intervention targets common infections that can negatively impact maternal and fetal health.
4. Health systems strengthening: Prior to the study, health centers involved in the ENAT study received training in antenatal care standards, guidelines, and measurements. Facilities were equipped with basic equipment, medications, and diagnostic testing. This strengthening of the health system benefits all women receiving care in these facilities.
Recommendations:
1. Implementation of enhanced nutrition packages: Based on the findings of the ENAT study, it is recommended to implement enhanced nutrition packages in antenatal care settings. This includes providing adequate iodized salt, iron-folate supplements, and nutrition counseling to pregnant women. Additionally, offering a micronutrient fortified balanced energy protein supplement to women with low mid-upper arm circumference can further improve nutritional status.
2. Integration of infection management interventions: The study highlights the importance of screening and treating urinary and sexual/reproductive tract infections during pregnancy. Integrating these interventions into routine antenatal care can help reduce the burden of infections and improve birth outcomes.
3. Health education and community sensitization: Community engagement and sensitization efforts should be strengthened to encourage early presentation at antenatal care clinics. This can help ensure that pregnant women receive timely and appropriate interventions to improve their health and the health of their babies.
Key Role Players:
1. Researchers and study staff: Responsible for implementing the study, collecting data, and analyzing the results.
2. Health center staff: Involved in delivering the interventions and providing antenatal care services to pregnant women.
3. Community leaders and volunteers: Play a crucial role in community sensitization and promoting the importance of antenatal care and the study interventions.
4. Ministry of Health: Provides guidance and support for the implementation of the study interventions and the integration of findings into existing healthcare systems.
Cost Items for Planning Recommendations:
1. Training and capacity building: Budget should include costs for training health center staff in antenatal care standards, guidelines, and measurements. This may involve hiring trainers, organizing workshops, and providing necessary resources.
2. Equipment and supplies: Budget should include costs for procuring basic equipment, medications, diagnostic testing tools, and ultrasound machines for health centers involved in the study.
3. Intervention materials: Budget should include costs for providing iodized salt, iron-folate supplements, and micronutrient fortified balanced energy protein supplements to pregnant women. This includes procurement, packaging, and distribution of these materials.
4. Monitoring and evaluation: Budget should include costs for data collection tools, electronic tablets, data management systems, and personnel involved in monitoring and evaluating the study progress.
5. Community engagement and sensitization: Budget should include costs for community outreach activities, including meetings, conferences, and educational materials to raise awareness about the importance of antenatal care and the study interventions.
Please note that the above cost items are estimates and may vary depending on the specific context and implementation strategies. It is important to conduct a detailed budget analysis and consult with relevant stakeholders to determine the actual cost of implementing the recommendations.

The strength of evidence for this abstract is 8 out of 10.
The evidence in the abstract is strong because it describes a well-designed study with a large sample size and clear objectives. The study is a pragmatic, open-label, randomized clinical effectiveness study implemented in 12 rural health centers in Ethiopia. It includes a comprehensive set of primary and secondary outcomes to measure the impact of the interventions. The study has been approved by the Institutional Review Boards and will be disseminated to local and international stakeholders. To improve the evidence, it would be helpful to provide more information on the statistical analysis plan and the expected effect sizes for the primary outcomes.

Introduction The 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 analysis ENAT 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 dissemination ENAT 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 number ISRCTN15116516.

The ENAT study is a 2×2 factorial pragmatic, open label, randomised clinical effectiveness study with cluster randomisation of the enhanced nutrition package (ENP) versus standard care (non-ENP) and individual level randomisation of an enhanced infection management package (EIMP) versus standard care (non-EIMP) (figure 2). Enhancing Nutrition and Antenatal Infection Treatment study consort diagram. BEP, balanced protein-energy; EIMP, enhanced infection management package; ENP, enhanced nutrition package; GA, gestational age; IFA, iron–folate; MUAC, mid-upper arm circumferences; RTI, reproductive tract infection; STI, sexually transmitted infection; UTI, urinary tract infection. The ENAT study site was established in 2018 as a partnership with the Addis Continental Institute of Public Health (ACIPH), Amhara Regional Health Bureau (ARHB), Amhara Public Health Institute (APHI) and Brigham and Women’s Hospital. The Amhara region has low-resourced health systems and poor health indicators. As per the 2016 Ethiopian Demographic Health Services data, Amhara had the country’s highest rates of neonatal mortality (47 per 1000 live births) and LBW (22.2%), and high maternal mortality rate (412 per 100 000 live births).28 Rates of any prenatal care and institutional delivery were 82.6% and 54.2%, respectively.29 One in four women of reproductive age are underweight (body mass index (BMI) <18.5 kg/m2)28 and geohelminth infections are prevalent, ranging from 21.1% to 43.5%.30 31 The ENAT study is conducted in 12 rural health centres (each serving~25 000 population) in West Gojjam (South and North Achefer districts (woredas)) and South Gondar (Dera and Libokemem districts) zones, Amhara (figure 3, Site Map). The districts were chosen in collaboration with the ARHB based on the high rates of undernutrition, risk of LBW, need for nutritional programmes and proximity to the regional laboratory. The study health centres were chosen based on accessibility, total ANC volume (minimum 250 women presenting to ANC/year) and infrastructure (functional laboratory). Enhancing Nutrition and Antenatal Infection Treatment study site map, Amhara region, Ethiopia. ENP, enhanced nutrition package. Prior to the study, formative work was conducted with a range of community members (mothers, families, community and religious leaders, health providers).32 This feedback directly informed the design of the study interventions, packages and their implementation. Community sensitisation was performed prior to initiating the study. Pregnant women are recruited from ANC visits in designated ENAT study health centres. A study nurse explains study procedures and obtains written informed consent. For illiterate women, an impartial witness attests to consent and the woman provides a thumbprint. To encourage early presentation at ANC clinics, community sensitisation was conducted prior to study initiation. Study field data collectors and community cadres disseminated information about the ENAT study at monthly community-based pregnant women’s conferences, and community and religious gatherings and encouraged presentation to the health centres if/as soon as pregnancy was suspected. Study enrolment began in August 2020 and will continue until the sample size has been met. As of 1 September 2021 ENAT has enrolled 2148 women. Health systems strengthening of ANC services was performed in ENAT health centres prior to the study to benefit all women receiving care in these facilities. Health systems strengthening was conducted in partnership with ARHB and Jhpiego. Health center staff were trained in ANC standards, guidelines and measurements (blood pressure, gestational age, birth weight33). Facilities were stocked with basic equipment, medications and diagnostic testing. Laboratory capacity was augmented, and all health centres were equipped with ultrasound machines (GE Vscan Access, General Electric, Boston, MA). ENAT study interventions are delivered within the health system at routine ANC visits by health center staff, with supervision provided by research staff. Routine ANC nutrition counselling includes increasing intake and dietary diversity, however, can vary depending on patient load. For ENP centres, supplementary, locally contextualised, counselling material was developed based on our formative work,32 and is delivered by midwives. Content includes BMI-based recommended weight gain, dietary diversity and educational messages developed to address local cultural beliefs related to dietary intake during pregnancy as well as side effects of IFA. Nutrition education materials, including posters and videos, are shown in ENP health centres to promote women’s behaviour change and maximise their exposure to various but consistent nutrition messages (table 1). Enhanced nutrition package (ENP) components ANC, antenatal care; ENP, enhanced nutrition package; IFA, iron–folate; MUAC, mid-upper arm circumferences. The Ethiopian Federal Ministry of Health (FMOH) recommends 60 mg iron plus 400 µg folic acid supplements, orally once daily in pregnancy. In August–September 2019, coverage of IFA was 46.3% in the ENAT health centres, and our formative work indicated that barriers included local beliefs about delivering ‘big babies’ and side effects such as constipation. In the ENP health centres, additional counselling is conducted, using video/media to address common cultural beliefs and side effects. Women are reminded at each ANC visit about IFA consumption, management of side effects and provided refills when their home IFA supply is low. In ENP centres, we provide a monthly household supply of high-quality adequately iodised salt at every ANC visit. The iodised salt (Waff Manufacturing, 30–40 ppm potassium iodate, 600 g bottle) is packaged in airtight, resealable, polyethylene containers, to allow resealing after use and to reduce risk of evaporative losses at the household level. Quality control procedures are in place to ensure that iodisation is in the proper range at production and maintained at distribution sites. Women are counselled that salt should be used to replace their household salt, on the approximate daily use (~10 g (three pinches)/day), the proper storage of salt (away from light, heat, humidity, recapping container after use) and use of salt only after cooking/heating of food. In the ENP health centres, women who have mid-upper arm circumferences (MUAC) 12 weeks (table 2). ENAT Enhanced infection management package (EIMP) components ENAT, Enhancing Nutrition and Antenatal Infection Treatment; FMOH, Ethiopian Federal Ministry of Health. A clean catch midstream urine specimen is collected using a vacutainer with boric acid preservative (Beckton Dickinson). Urine culture and antibiotic susceptibility testing are performed at APHI, the regional laboratory certified by the ENAO (Ethiopian National Accreditation Office)—ISO (International Organization for Standardization) 15189. Antibiotic susceptibility is determined including the Vitek method (bioMerieux, Marcy l’Etoile, France), or Kirby Bauer Disk Diffusion. Urinary tract infections are classified in online supplemental web table 3 and treated with an oral antibiotic-based on antibiotic sensitivity patterns (online supplemental web table 4). Antibiotics are provided to pregnant women at no cost and the first dose is directly observed. Women with severe illness or difficult to treat infections are referred to the Obstetrics Department at Felege Hiwot Hospital. Women provide a test of cure specimens at the following ANC visit. Women self-collect vaginal specimens (mid-vaginal swab) that are tested for gonorrhoea and chlamydia with the Xpert CT/NG assay (Cepheid, Sunnyvale, California)using the GeneXpert nucleic acid amplification testing platform at APHI. Chlamydia is treated with azithromycin 1 g orally once and gonorrhoea is treated with ceftriaxone 250 mg intramuscular +azithromycin 1 g orally once. Partner treatment is on a voluntary basis with a regimen as recommended by the Ethiopian sexually transmitted infections management guidelines.36 A test of cure is obtained at the next ANC visit. For women who report symptoms of abnormal vaginal discharge, vulvar symptoms or lower abdominal tenderness, additional vaginal swabs are collected for trichomonas and bacterial vaginosis by point of care diagnostics. Trichomonas is tested using the OSOM trichomonas rapid test (Sekisui Diagnostics, Massachusetts). Bacterial vaginosis is tested using Diagnosit BVBLUE test (Gryphus Diagnostics, Knoxville, Tennessee). Trichomonas is treated with metronidazole 2 g orally once, and partners are treated. Bacterial vaginosis is treated with metronidazole 500 mg two times per day for 7 days. In settings of high geohelminth burden, WHO recommends prophylactic deworming in second and third trimester of pregnancy.37 At study initiation, mebendazole (500 mg) was provided two times in pregnancy consistent with WHO guidelines. Due to health provider concerns regarding medication package insert information contraindicating use in early pregnancy, in September 2020, the protocol was modified to a single presumptive deworming in the third trimester. In May 2021, with the adoption of new Ethiopian FMOH ANC guidelines allowing earlier provision of antihelminthics in pregnancy, the ENAT protocol was modified to provide presumptive deworming in the second trimester followed by a stool screening and treatment at least 4 weeks later. In the first post-deworming visit, stool is screened for intestinal parasites in the health centre laboratory using wet mount microscopy available at the health centre. Women identified with parasitic infections are treated as per FMOH recommendations (online supplemental web table 4). At the first level of randomisation, clusters (ie, health centres) are randomised into one of two nutrition interventions: (a) ENP or (b) standard nutrition care. We performed a constrained randomisation to ensure balance across the two arms of the study for key indicators including: population size, pre-study ANC coverage rates, number of births and travel time to the regional centre of Bahir Dar. We: (1) set reasonable tolerance levels for the restriction variables, (2) created all possible random sequences, where each sequence allocated six health centres to the ENAT Nutrition Package and six health centres to routine care, (3) assessed each sequence as to whether or not it met these restriction criteria and (4) chose randomly from the subset of all such allocation sequences that met the criteria. At the second level of randomisation, we randomised individual pregnant women presenting for ANC at each health centre to receive (a) ENAT EIMP, or (b) standard infection care (figure 2). Each health centre received a pre-generated randomisation list of sequential individual assignments to EIMP or standard care, where assignments were equally allocated to each arm within randomly permuted blocks of size 4, 8 or 12. The randomisation lists were generated separately, by health centre, using a script written by one of the authors (LCM) in R.38 The primary outcomes are P1. Newborn weight measured within 72 hours of birth. P2. Newborn length measured within 72 hours of birth. The secondary outcomes include: S1. Length of gestation, with gestational age determined by <=24-week pregnancy ultrasonography. S2a. Proportion of pregnancies resulting in spontaneous delivery at <37 weeks gestation. S2b. Proportion of livebirths born <37 weeks gestation S3. Proportion of newborns born small-for-gestational age, as defined by the INTERGROWTH 21st neonatal birth weight standard. S4. Proportion of newborns born of LBW (<2500 g), as measured within 72 hours of life. S5. Stillbirth rate. S6. Newborn head circumference within 72 hours of birth. S7. Infant Z-scores for weight-for-age, length-for-age, head circumference-for-age within 72 hours of birth. S8. Maternal gestational weight gain. S9. Maternal anaemia (third trimester). The definitions used for each outcome measure is shown in table 3. Enhancing Nutrition and Antenatal Infection Treatment study outcomes BPD, biparietal diameter; CRL, crown rump length; FL, femur length; GA, gestational age. The timeline of individual participant study visits, measurements and data collection are shown in table 4. All data collection and study measurements are performed by research staff (study nurses or data collectors) after routine ANC visits. Study visits are conducted at the health centre, with the exception of the birth visit that may be conducted at home within 72 hours of delivery, for births occurring at home or outside of the study area. Adherence monitoring visits also occur at the home for those participants who do not return to the health centre for follow-up. Participant timeline schedule of enrolment, interventions, assessment and visits ANC, antenatal care; EIMP, enhanced infection management package; ENP, enhanced nutrition package; GA, gestational age. The core of the data collection system is the Survey Solutions platform (World Bank, V.20.08, 2021). Study nurses enter data directly into electronic tablets with programmed validity checks during study visits. Paper forms are used if tablets are temporarily unavailable. The tablets are regularly synchronised to the server on the ACIPH campus. A web-based dashboard supports data collectors, supervisors and investigators in real time management and monitoring of study activities. At the enrolment visit at the health centre, data are collected on the participant’s socioeconomic status, basic medical and obstetrical history, pregnancy history, maternal morbidity including COVID-19, food security and dietary intake. A dietary quality questionnaire is administered, which has been used in the Ethiopian context.39 A basic abdominal obstetric ultrasound (GE VScan Access) is performed by a trained research nurse at the enrolment visit for pregnancy dating. An intensive ultrasonography training and standardisation was performed by General Electric, Ethiopian Radiography Association and sonographers from Beth Israel Deaconess Hospital (Boston, Massachusetts). Sonographers measure crown-rump length, biparietal diameter (outer to inner), head circumference, femoral length, abdominal circumference in duplicate. Approximately 10% of images are externally reviewed (MS, BJW) for quality control. Maternal and infant anthropometrics are measured by research staff (nurses, data collectors) at baseline and follow-up visits (table 3). Maternal weight is measured with a digital scale (ADE M317600, Germany; precision 100 g) and height is measured using an adult stadiometer (Shorr Productions HeightLite). All measurements are performed two times, with a third measurement done if the difference is greater than the minimal acceptable difference defined by INTERGROWTH 21st.40 Study nurses and data collectors are trained and standardised in anthropometric measurements at the start of the study and every 6 months. During the follow-up ANC visits at the health centre, research staff interview women about their health status, morbidity, pregnancy history/complications, counselling/services received, maternal mental health screen and dietary intake. Data are abstracted from routine ANC records, including blood pressure, laboratory testing results and management. Maternal weight and MUAC are measured. In a subset of women, a semi-quantitative food frequency questionnaire for ~70 food items is administered at ANC visits. Haemoglobin is measured at enrolment and third trimester ANC visits (HemoCue 301 c). Venous haemoglobin is measured if blood is already being drawn for other purposes, and otherwise capillary haemoglobin is measured. Adherence to each nutritional supplement is assessed at ANC visits. The participant is asked to bring the used IFA bottle, salt container and BEP sachets back to the health centre at each ANC visit. Pill or empty sachet count is done, and the salt container weighed. The participant is also asked to recall the number of sachets and/or pills that were taken in the last 7 days, and since the last visit. For mothers who do not attend scheduled ANC visits, a home visit is made by a data collector to assess adherence and conduct pill/sachet counts and remind the mother to return for ANC and study visits. A repeat ultrasound is performed in the third trimester to monitor fetal growth and assess the position of the baby. If the fetus is determined to be in non-vertex positioning at the third trimester scan, the nurse recommends that the women deliver in the nearest hospital with caesarean section capacity. Participants who deliver in health facilities are assessed by research staff based in health centres or hospitals as soon as possible after birth, but within 72 hours of life. Data are gathered from women and from chart review about the delivery and immediate postpartum period. Medical records are reviewed for intrapartum course (eg, vital signs, duration of labour), delivery complications and maternal/neonatal morbidity. For deliveries that occur at home, a home visit is made by research staff as soon as possible on birth notification (within 72 hours). Maternal history is obtained per self-report regarding delivery history/complications, and postpartum maternal/neonatal morbidity. Infant weight is measured using a high quality, precise digital infant scale (ADE M112600, Germany; precision 5 g). Infant length is measured using a portable infantometer (Perspective Enterprises PE-RILB-LTWT, Michigan USA, precision 1 mm). Recumbent length is recorded to the last completed (not the nearest) millimetre (mm). Head, chest and MUAC is measured to the nearest mm using insertion tapes (Shorr productions, Maryland USA). Daily calibration checks are made before each use of infant weighing scales, and length boards to ensure accuracy of measurement.41 42 Postnatal visits are made at 4–6 weeks for all participants to collect data on maternal and infant vital status, health, morbidity and anthropometrics. Visits are conducted primarily at the health centre, and home visits are made for those who do not return for follow-up. For infants who follow-up at the health centre for routine postnatal care or immunisations, study visits are additionally conducted at 3 and 6 months. Data regarding the costs of delivery of the ENAT study interventions is collected in all study arms. Costs of interventions include three components: system-level costs, costs incurred by health workers for participating in the interventions and costs incurred by individual patients and families. At the system level, costs are captured using the WHO framework 43 using modified survey tools based on our published survey instruments, cost estimation protocols and procedures that have been validated and used in other LMICs (eg, Rwanda, India);44–46 Costs incurred by health workers for receiving training include time or money spent for participating in training sessions. For all time spent, monetary value is assigned based on their average hourly wage. Costs incurred by patients include costs or time spent for received care or home visits. For visits in health facilities, we collect self-reported cost data from patients. In a subset of consenting women, additional biospecimens will be collected for future analysis. These specimens are shown in online supplemental web table 5. Data collected in this study will enable us to conduct a comprehensive analysis of the impact of interventions randomised at the health centre and individual level. The detailed Statistical Analysis Plan of the ENAT study is published separately at: https://addiscontinentaleduet/. In brief, our statistical approach will have multiple steps. We will describe the health centres and pregnant women enrolled in the study and conduct a descriptive quantitative analysis of variables at multiple levels to assess the degree to which our randomisation scheme resulted in similar subpopulations of pregnant women. We will assess the receipt of and adherence to interventions offered, conduct descriptive analyses of the primary and secondary outcomes, compare the outcomes between intervention groups, assess potential effect modifiers and conduct prespecified subgroup and sensitivity analyses. We have estimated the effect size detectable with 80% power under a cluster-randomised design, with six health centres per study arm. Fixing recruitment of pregnant women to 18 months, we estimated that within this time period the average health centre in the proposed study site would enrol around 200 women into ANC at ≤24 weeks gestation and would yield 112 live born infants weighed within 72 hours of life (assuming~70% of enrolled pregnancies result in a live birth and ~80% are followed-up and weighed within 72 hours). Beyond the above determination of average cluster size, we have additionally made the following assumptions in order to estimate effect sizes detectable with 80% power: (1) mean birth weight and SD as per prior studies in Gondor (mean birth weight of 2900 g, SD 450 g) and (2) variation in distribution of weight between clusters as reflected through an coefficient of variation (k=0.01).47 In total this includes 2400 pregnant mothers enrolled in 12 health centres, resulting in 1440 live births with a birth weight within 72 hours. This sample size provides 80% power to detect a 66 g difference in birth weight between the ENAT EIMP or routine care group in a marginal analysis (ie, irrespective of whether mothers did or did not receive the ENP), and a 90 g difference between ENP versus routine care (marginal analysis). With the assumptions of clusters and enrolment above, we assumed mean infant length of 49.5 cm (SD 2.4) (based on data from Malawi 48 49 and coefficient of variation k=0.008 (sector level variation in JiVitA study).47 For the EIMP versus routine care comparison, we would have 80% power to detect a 3.0 mm difference in mean infant length. For the ENP versus non-ENP comparison (marginal analysis) we would have 80% power to detect a 7.8 mm difference in infant length between the women receiving the package of enhanced nutrition-infection compared with standard nutrition care. An external Study Monitoring Committee (SMC) is established to monitor the progress of the study, including enrolment, progress indicators and adverse events. The SMC includes an independent Ethiopian obstetrician (Dr Delayehu Bekele) and an epidemiologist (Professor Simon Cousens). The committee met before study initiation, at mid-enrolment and every 6 months to review study progress. Interim analysis will not be performed.

The ENAT study aims to improve birth outcomes in rural Ethiopia by testing the impact of packages of pregnancy interventions to enhance maternal nutrition and infection management. The study includes several innovations to improve access to maternal health:

1. Enhanced Nutrition Package (ENP): Women in ENP centers receive a regular supply of adequately iodized salt and iron-folate (IFA), enhanced nutrition counseling, and a micronutrient fortified balanced energy protein supplement. This package aims to address undernutrition and micronutrient deficiencies in pregnant women.

2. Enhanced Infection Management Package (EIMP): Women in EIMP receive additional screening and treatment for urinary and sexual/reproductive tract infections, as well as intensive deworming. This package aims to address common infections that can affect maternal and fetal health.

3. Health Systems Strengthening: ANC quality is strengthened across all health centers participating in the study. This includes training health center staff in ANC standards and guidelines, stocking facilities with necessary equipment and medications, and improving laboratory capacity.

4. Community Sensitization: Prior to the study, formative work was conducted with community members to inform the design of interventions and packages. Community sensitization activities were conducted to encourage early presentation at ANC clinics and raise awareness about the study.

5. Use of Technology: Data collection is done using electronic tablets with programmed validity checks, allowing for real-time management and monitoring of study activities. This improves efficiency and accuracy in data collection.

6. Cost Analysis: The study also includes the collection of data on the costs of delivering the interventions. This information will help assess the feasibility and sustainability of implementing the interventions in real-world settings.

These innovations aim to address the specific challenges faced in rural Ethiopia, such as high rates of neonatal mortality, low birth weight, and maternal mortality. By improving access to maternal health through enhanced nutrition and infection management, the ENAT study seeks to contribute to the global goal of reducing low birth weight and improving birth outcomes.
AI Innovations Description
The ENAT study aims to improve birth outcomes in rural Ethiopia by testing the impact of pregnancy interventions on enhancing maternal nutrition and infection management. The study is a 2×2 factorial design, with cluster randomization of the enhanced nutrition package (ENP) versus standard care and individual-level randomization of the enhanced infection management package (EIMP) versus standard care.

The ENP intervention includes providing pregnant women with a regular supply of adequately iodized salt and iron-folate (IFA), enhanced nutrition counseling, and a micronutrient fortified balanced energy protein supplement for those with mid-upper arm circumference (MUAC) of less than 23 cm. In contrast, the standard nutrition care group receives routine counseling and IFA.

The EIMP intervention involves additional screening and treatment for urinary and sexual/reproductive tract infections, as well as intensive deworming. Women in the non-EIMP group are managed syndromically according to Ministry of Health guidelines.

The primary outcomes of the study are newborn weight and length measured within 72 hours of birth. Secondary outcomes include preterm birth, low birth weight, stillbirth rates, newborn head circumference, infant weight and length for age z-scores at birth, maternal anemia, and weight gain during pregnancy.

The study is being conducted in 12 rural health centers in the Amhara region of Ethiopia, which has high rates of neonatal mortality, low birth weight, and maternal mortality. Health centers were selected based on accessibility, ANC volume, and infrastructure.

Data collection is performed by research staff using electronic tablets with programmed validity checks. Anthropometric measurements, laboratory testing, and interviews are conducted at various study visits, including ANC visits, delivery visits, and postnatal visits.

The study also includes a cost analysis to assess the costs of delivering the interventions at the system, health worker, and patient levels.

The ENAT study has ethical approval and results will be disseminated to local and international stakeholders.

Overall, the study aims to provide evidence on the effectiveness of packages of pregnancy interventions to improve birth outcomes and inform strategies to enhance access to maternal health services in rural Ethiopia.
AI Innovations Methodology
The ENAT study aims to improve birth outcomes in rural Ethiopia by testing the impact of packages of pregnancy interventions to enhance maternal nutrition and infection management. The study is a pragmatic, open-label, 2×2 factorial, randomized clinical effectiveness study implemented in 12 rural health centers in Amhara, Ethiopia. Here are some potential recommendations to improve access to maternal health based on the ENAT study:

1. Strengthen ANC Quality: Enhance the quality of antenatal care (ANC) services across all health centers by providing training to health center staff on ANC standards, guidelines, and measurements. This will ensure that pregnant women receive comprehensive and standardized care.

2. Enhanced Nutrition Package (ENP): Implement an enhanced nutrition package in selected health centers. This package includes providing pregnant women with a regular supply of adequately iodized salt and iron-folate (IFA), enhanced nutrition counseling, and a micronutrient fortified balanced energy protein supplement (corn soya blend) for women with mid-upper arm circumference (MUAC) of

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