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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Autores principales: 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
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Publicado: Public Library of Science (PLoS) 2010
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spelling 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)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle 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.
description <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
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