The impact of enhancing nutrition and antenatal infection treatment on birth outcomes in Amhara, Ethiopia: a pragmatic factorial, cluster-randomised clinical effectiveness study
Introduction We aimed to determine the impact of antenatal interventions to optimise maternal nutrition and infection management on birth outcomes in Ethiopia.Methods We conducted a pragmatic, open-label, 2×2 factorial randomised clinical effectiveness study among pregnant women enrolled <24...
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2025-06-01
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| author | Alemayehu Worku Sheila Isanaka Yemane Berhane Chunling Lu Grace J Chan Luke C Mullany Blair J Wylie Michelle Eglovitch Anne CC Lee Parul Christian Estifanos Baye Krysten North Tigest Shifraw Yoseph Yemane Berhane Mulatu Melese Derebe Nebiyou Fasil Workagegnehu Tarekegn Kidane Fisseha Shiferie Sitota Tsegaye Kalkidan Yibeltal Yunhee Kang Mandefro M Mengistie Fred Van Dyk Amare Worku Tadesse Rose L Molina Firehiwot Workneh Ingrid Olson |
| author_facet | Alemayehu Worku Sheila Isanaka Yemane Berhane Chunling Lu Grace J Chan Luke C Mullany Blair J Wylie Michelle Eglovitch Anne CC Lee Parul Christian Estifanos Baye Krysten North Tigest Shifraw Yoseph Yemane Berhane Mulatu Melese Derebe Nebiyou Fasil Workagegnehu Tarekegn Kidane Fisseha Shiferie Sitota Tsegaye Kalkidan Yibeltal Yunhee Kang Mandefro M Mengistie Fred Van Dyk Amare Worku Tadesse Rose L Molina Firehiwot Workneh Ingrid Olson |
| author_sort | Alemayehu Worku |
| collection | DOAJ |
| description | Introduction We aimed to determine the impact of antenatal interventions to optimise maternal nutrition and infection management on birth outcomes in Ethiopia.Methods We conducted a pragmatic, open-label, 2×2 factorial randomised clinical effectiveness study among pregnant women enrolled <24 weeks gestation in 12 rural health centres in Amhara, Ethiopia. Eligible health centres were randomised to deliver an enhanced nutrition package (ENP) (iron-folic acid, iodised salt and targeted micronutrient fortified balanced energy protein (BEP) supplementation for undernourished women) or routine nutrition care (iron-folic acid only). Individual women were randomised to receive an enhanced infection management package (EIMP) (genitourinary tract infection screening-treatment and enhanced deworming) or routine infection care (syndromic management). The primary outcomes were birth weight and length; secondary outcomes were gestational age, preterm delivery, small-for-gestational-age, low birth weight, stillbirth, newborn weight-for-age and length-for-age z-scores, newborn head circumference, and maternal anemia. Analysis was intention to treat.Results From August 2020 to December 2021, 2392 women were randomised (604 ENP+EIMP, 600 ENP alone, 593 EIMP alone and 595 neither package) and followed until June 2022, with 2170 pregnancy outcomes analysed (565 ENP+EIMP, 549 ENP, 525 EIMP, 531 neither). In the ENP arm, 427 (36%) women were eligible for BEP and consumed on average 74 days. The prevalence of genitourinary tract infection was low (4.9%), while parasitic stool infections were common (31%). There was no difference in birth weight (ENP vs not-ENP: adjusted mean difference −4 g (−83 to 75); EIMP vs not-EIMP: 18 g (−35 to 70); ENP+EIMP vs neither: 14 g (−81 to 109)) or birth length (ENP: −0.3 cm (−1.1 to 0.5); EIMP: 0.2 cm (−0.1 to 0.5); ENP+EIMP: −0.1 cm (−1.2 to 1.1)) between study arms. In the ENP+EIMP group, the stillbirth rate was lower compared with the arm receiving neither package (7.1/1000 vs 24.7/1000 births; adjusted relative risk: 0.29 (0.09 to 0.94)). The packages did not significantly affect other secondary outcomes.Conclusions In this pragmatic study implemented within the Ethiopian health system, enhanced nutrition and infection packages did not affect birth weight or length. While stillbirth rates were lower in the group receiving both packages, these findings need to be supported by additional studies.Trial registration number ISRCTN15116516. |
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| language | English |
| publishDate | 2025-06-01 |
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| spelling | doaj-art-2b9fa72e424645a99220b1d9c43e066d2025-08-20T02:09:56ZengBMJ Publishing GroupBMJ Global Health2059-79082025-06-0110610.1136/bmjgh-2024-016264The impact of enhancing nutrition and antenatal infection treatment on birth outcomes in Amhara, Ethiopia: a pragmatic factorial, cluster-randomised clinical effectiveness studyAlemayehu Worku0Sheila Isanaka1Yemane Berhane2Chunling Lu3Grace J Chan4Luke C Mullany5Blair J Wylie6Michelle Eglovitch7Anne CC Lee8Parul Christian9Estifanos Baye10Krysten North11Tigest Shifraw12Yoseph Yemane Berhane13Mulatu Melese Derebe14Nebiyou Fasil15Workagegnehu Tarekegn Kidane16Fisseha Shiferie17Sitota Tsegaye18Kalkidan Yibeltal19Yunhee Kang20Mandefro M Mengistie21Fred Van Dyk22Amare Worku Tadesse23Rose L Molina24Firehiwot Workneh25Ingrid Olson263 Department of Epidemiology and Biostatistics, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia13 Departments of Nutrition and Global Health and Population, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA3 Department of Epidemiology and Biostatistics, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia9 Harvard Medical School, Boston, Massachusetts, USA11 Department of Pediatrics, University of Pennsylvania, Philadelphia, PA, USA4 Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA14 Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA2 Department of Pediatrics, Brigham and Women’s Hospital, Boston, Massachusetts, USA1 Department of Pediatrics, Brown University, Providence, Rhode Island, USA4 Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA2 Department of Pediatrics, Brigham and Women’s Hospital, Boston, Massachusetts, USA2 Department of Pediatrics, Brigham and Women’s Hospital, Boston, Massachusetts, USA5 Department of Reproductive Health and Population, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia3 Department of Epidemiology and Biostatistics, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia8 Amhara Public Health Institute, Bahir Dar, Ethiopia6 Department of Global Health and Health Policy, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia7 Department of Nutrition and Behavioral Science, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia3 Department of Epidemiology and Biostatistics, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia7 Department of Nutrition and Behavioral Science, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia5 Department of Reproductive Health and Population, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia4 Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA8 Amhara Public Health Institute, Bahir Dar, Ethiopia4 Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA7 Department of Nutrition and Behavioral Science, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia9 Harvard Medical School, Boston, Massachusetts, USA3 Department of Epidemiology and Biostatistics, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia2 Department of Pediatrics, Brigham and Women’s Hospital, Boston, Massachusetts, USAIntroduction We aimed to determine the impact of antenatal interventions to optimise maternal nutrition and infection management on birth outcomes in Ethiopia.Methods We conducted a pragmatic, open-label, 2×2 factorial randomised clinical effectiveness study among pregnant women enrolled <24 weeks gestation in 12 rural health centres in Amhara, Ethiopia. Eligible health centres were randomised to deliver an enhanced nutrition package (ENP) (iron-folic acid, iodised salt and targeted micronutrient fortified balanced energy protein (BEP) supplementation for undernourished women) or routine nutrition care (iron-folic acid only). Individual women were randomised to receive an enhanced infection management package (EIMP) (genitourinary tract infection screening-treatment and enhanced deworming) or routine infection care (syndromic management). The primary outcomes were birth weight and length; secondary outcomes were gestational age, preterm delivery, small-for-gestational-age, low birth weight, stillbirth, newborn weight-for-age and length-for-age z-scores, newborn head circumference, and maternal anemia. Analysis was intention to treat.Results From August 2020 to December 2021, 2392 women were randomised (604 ENP+EIMP, 600 ENP alone, 593 EIMP alone and 595 neither package) and followed until June 2022, with 2170 pregnancy outcomes analysed (565 ENP+EIMP, 549 ENP, 525 EIMP, 531 neither). In the ENP arm, 427 (36%) women were eligible for BEP and consumed on average 74 days. The prevalence of genitourinary tract infection was low (4.9%), while parasitic stool infections were common (31%). There was no difference in birth weight (ENP vs not-ENP: adjusted mean difference −4 g (−83 to 75); EIMP vs not-EIMP: 18 g (−35 to 70); ENP+EIMP vs neither: 14 g (−81 to 109)) or birth length (ENP: −0.3 cm (−1.1 to 0.5); EIMP: 0.2 cm (−0.1 to 0.5); ENP+EIMP: −0.1 cm (−1.2 to 1.1)) between study arms. In the ENP+EIMP group, the stillbirth rate was lower compared with the arm receiving neither package (7.1/1000 vs 24.7/1000 births; adjusted relative risk: 0.29 (0.09 to 0.94)). The packages did not significantly affect other secondary outcomes.Conclusions In this pragmatic study implemented within the Ethiopian health system, enhanced nutrition and infection packages did not affect birth weight or length. While stillbirth rates were lower in the group receiving both packages, these findings need to be supported by additional studies.Trial registration number ISRCTN15116516.https://gh.bmj.com/content/10/6/e016264.full |
| spellingShingle | Alemayehu Worku Sheila Isanaka Yemane Berhane Chunling Lu Grace J Chan Luke C Mullany Blair J Wylie Michelle Eglovitch Anne CC Lee Parul Christian Estifanos Baye Krysten North Tigest Shifraw Yoseph Yemane Berhane Mulatu Melese Derebe Nebiyou Fasil Workagegnehu Tarekegn Kidane Fisseha Shiferie Sitota Tsegaye Kalkidan Yibeltal Yunhee Kang Mandefro M Mengistie Fred Van Dyk Amare Worku Tadesse Rose L Molina Firehiwot Workneh Ingrid Olson The impact of enhancing nutrition and antenatal infection treatment on birth outcomes in Amhara, Ethiopia: a pragmatic factorial, cluster-randomised clinical effectiveness study BMJ Global Health |
| title | The impact of enhancing nutrition and antenatal infection treatment on birth outcomes in Amhara, Ethiopia: a pragmatic factorial, cluster-randomised clinical effectiveness study |
| title_full | The impact of enhancing nutrition and antenatal infection treatment on birth outcomes in Amhara, Ethiopia: a pragmatic factorial, cluster-randomised clinical effectiveness study |
| title_fullStr | The impact of enhancing nutrition and antenatal infection treatment on birth outcomes in Amhara, Ethiopia: a pragmatic factorial, cluster-randomised clinical effectiveness study |
| title_full_unstemmed | The impact of enhancing nutrition and antenatal infection treatment on birth outcomes in Amhara, Ethiopia: a pragmatic factorial, cluster-randomised clinical effectiveness study |
| title_short | The impact of enhancing nutrition and antenatal infection treatment on birth outcomes in Amhara, Ethiopia: a pragmatic factorial, cluster-randomised clinical effectiveness study |
| title_sort | impact of enhancing nutrition and antenatal infection treatment on birth outcomes in amhara ethiopia a pragmatic factorial cluster randomised clinical effectiveness study |
| url | https://gh.bmj.com/content/10/6/e016264.full |
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