Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh.
<h4>Background</h4>To evaluate a delivery strategy for newborn interventions in rural Bangladesh.<h4>Methods</h4>A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproduc...
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oai:doaj.org-article:3ede6cd2df8f4909990f4fa32e592b052021-11-25T06:25:08ZEvaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh.1932-620310.1371/journal.pone.0009696https://doaj.org/article/3ede6cd2df8f4909990f4fa32e592b052010-03-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/20352087/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>To evaluate a delivery strategy for newborn interventions in rural Bangladesh.<h4>Methods</h4>A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality.<h4>Findings</h4>A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80-1.30) at baseline and 0.87 (95% CI: 0.68-1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported.<h4>Conclusion</h4>Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management.<h4>Trial registration</h4>Clinicaltrials.gov NCT00198627.Gary L DarmstadtYoonjoung ChoiShams E ArifeenSanwarul BariSyed M RahmanIshtiaq MannanHabibur Rahman SerajiPeter J WinchSamir K SahaA S M Nawshad Uddin AhmedSaifuddin AhmedNazma BegumAnne C C LeeRobert E BlackMathuram SantoshamDerrick CrookAbdullah H BaquiBangladesh Projahnmo-2 Mirzapur Study GroupPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 5, Iss 3, p e9696 (2010) |
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Medicine R Science Q Gary L Darmstadt Yoonjoung Choi Shams E Arifeen Sanwarul Bari Syed M Rahman Ishtiaq Mannan Habibur Rahman Seraji Peter J Winch Samir K Saha A S M Nawshad Uddin Ahmed Saifuddin Ahmed Nazma Begum Anne C C Lee Robert E Black Mathuram Santosham Derrick Crook Abdullah H Baqui Bangladesh Projahnmo-2 Mirzapur Study Group Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh. |
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<h4>Background</h4>To evaluate a delivery strategy for newborn interventions in rural Bangladesh.<h4>Methods</h4>A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality.<h4>Findings</h4>A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80-1.30) at baseline and 0.87 (95% CI: 0.68-1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported.<h4>Conclusion</h4>Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management.<h4>Trial registration</h4>Clinicaltrials.gov NCT00198627. |
format |
article |
author |
Gary L Darmstadt Yoonjoung Choi Shams E Arifeen Sanwarul Bari Syed M Rahman Ishtiaq Mannan Habibur Rahman Seraji Peter J Winch Samir K Saha A S M Nawshad Uddin Ahmed Saifuddin Ahmed Nazma Begum Anne C C Lee Robert E Black Mathuram Santosham Derrick Crook Abdullah H Baqui Bangladesh Projahnmo-2 Mirzapur Study Group |
author_facet |
Gary L Darmstadt Yoonjoung Choi Shams E Arifeen Sanwarul Bari Syed M Rahman Ishtiaq Mannan Habibur Rahman Seraji Peter J Winch Samir K Saha A S M Nawshad Uddin Ahmed Saifuddin Ahmed Nazma Begum Anne C C Lee Robert E Black Mathuram Santosham Derrick Crook Abdullah H Baqui Bangladesh Projahnmo-2 Mirzapur Study Group |
author_sort |
Gary L Darmstadt |
title |
Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh. |
title_short |
Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh. |
title_full |
Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh. |
title_fullStr |
Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh. |
title_full_unstemmed |
Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh. |
title_sort |
evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in mirzapur, bangladesh. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2010 |
url |
https://doaj.org/article/3ede6cd2df8f4909990f4fa32e592b05 |
work_keys_str_mv |
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