Cargando…

Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. In Afghanistan, where most births take place at home without the assistance of a skilled birth attendant, there is a need for options to manage PPH in community-based settings. Misoprostol, a uterotonic tha...

Descripción completa

Detalles Bibliográficos
Autores principales: Abbas, Dina F., Mirzazada, Shafiq, Durocher, Jill, Pamiri, Shahfaqir, Byrne, Meagan E., Winikoff, Beverly
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7275481/
https://www.ncbi.nlm.nih.gov/pubmed/32503556
http://dx.doi.org/10.1186/s12978-020-00933-8
_version_ 1783542793102163968
author Abbas, Dina F.
Mirzazada, Shafiq
Durocher, Jill
Pamiri, Shahfaqir
Byrne, Meagan E.
Winikoff, Beverly
author_facet Abbas, Dina F.
Mirzazada, Shafiq
Durocher, Jill
Pamiri, Shahfaqir
Byrne, Meagan E.
Winikoff, Beverly
author_sort Abbas, Dina F.
collection PubMed
description BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. In Afghanistan, where most births take place at home without the assistance of a skilled birth attendant, there is a need for options to manage PPH in community-based settings. Misoprostol, a uterotonic that has been used as prophylaxis at the household level and has also been proven to be effective in treating PPH in hospital settings, is one possible option. METHODS: A double-blind, randomized placebo-controlled trial was conducted in six districts in Badakhshan Province, Afghanistan to test the effectiveness and safety of administering 800mcg sublingual misoprostol to women after a home birth for treatment of excessive blood loss. Consenting women were enrolled prior to delivery and given 600mcg misoprostol to self-administer orally as prophylaxis. Community health workers (CHW) were trained to observe for signs of PPH after delivery and if PPH was diagnosed, administer the study medication (misoprostol or placebo) and immediately refer the woman. A hemoglobin (Hb) decline of 2 g/dL or greater, measured pre- and post-delivery, served as the primary outcome; side effects, additional interventions, and transfer rates were also analyzed. RESULTS: Among the 1884 women who delivered at home, nearly all (98.7%) reported self-use of misoprostol for PPH prevention. A small fraction was diagnosed with PPH (4.4%, 82/1884) and was administered treatment. Hb outcomes, including the proportion of women with a Hb drop of 2 g/dL or greater, were similar between the study groups (misoprostol: 56.4% (22/39), placebo: 60.6% (20/33), p = 0.45). Significantly more women randomized to receive misoprostol experienced shivering (82.5% vs. placebo: 61.5%, p = 0.03). Other side effects were similar between study groups and none required treatment, including among the subset of 39 women, who received misoprostol for both of its PPH indications. CONCLUSIONS: While the study did not document a clinical benefit associated with misoprostol for treatment of PPH, study findings suggest that use of misoprostol for both prevention and treatment in the same birth as well as its use by lay level providers in home births does not result in any safety concerns. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov, number NCT01508429 Registered on December 1, 2011.
format Online
Article
Text
id pubmed-7275481
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-72754812020-06-08 Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan Abbas, Dina F. Mirzazada, Shafiq Durocher, Jill Pamiri, Shahfaqir Byrne, Meagan E. Winikoff, Beverly Reprod Health Research BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. In Afghanistan, where most births take place at home without the assistance of a skilled birth attendant, there is a need for options to manage PPH in community-based settings. Misoprostol, a uterotonic that has been used as prophylaxis at the household level and has also been proven to be effective in treating PPH in hospital settings, is one possible option. METHODS: A double-blind, randomized placebo-controlled trial was conducted in six districts in Badakhshan Province, Afghanistan to test the effectiveness and safety of administering 800mcg sublingual misoprostol to women after a home birth for treatment of excessive blood loss. Consenting women were enrolled prior to delivery and given 600mcg misoprostol to self-administer orally as prophylaxis. Community health workers (CHW) were trained to observe for signs of PPH after delivery and if PPH was diagnosed, administer the study medication (misoprostol or placebo) and immediately refer the woman. A hemoglobin (Hb) decline of 2 g/dL or greater, measured pre- and post-delivery, served as the primary outcome; side effects, additional interventions, and transfer rates were also analyzed. RESULTS: Among the 1884 women who delivered at home, nearly all (98.7%) reported self-use of misoprostol for PPH prevention. A small fraction was diagnosed with PPH (4.4%, 82/1884) and was administered treatment. Hb outcomes, including the proportion of women with a Hb drop of 2 g/dL or greater, were similar between the study groups (misoprostol: 56.4% (22/39), placebo: 60.6% (20/33), p = 0.45). Significantly more women randomized to receive misoprostol experienced shivering (82.5% vs. placebo: 61.5%, p = 0.03). Other side effects were similar between study groups and none required treatment, including among the subset of 39 women, who received misoprostol for both of its PPH indications. CONCLUSIONS: While the study did not document a clinical benefit associated with misoprostol for treatment of PPH, study findings suggest that use of misoprostol for both prevention and treatment in the same birth as well as its use by lay level providers in home births does not result in any safety concerns. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov, number NCT01508429 Registered on December 1, 2011. BioMed Central 2020-06-05 /pmc/articles/PMC7275481/ /pubmed/32503556 http://dx.doi.org/10.1186/s12978-020-00933-8 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Abbas, Dina F.
Mirzazada, Shafiq
Durocher, Jill
Pamiri, Shahfaqir
Byrne, Meagan E.
Winikoff, Beverly
Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan
title Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan
title_full Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan
title_fullStr Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan
title_full_unstemmed Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan
title_short Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan
title_sort testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in badakhshan province, afghanistan
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7275481/
https://www.ncbi.nlm.nih.gov/pubmed/32503556
http://dx.doi.org/10.1186/s12978-020-00933-8
work_keys_str_mv AT abbasdinaf testingahomebasedmodelofcareusingmisoprostolforpreventionandtreatmentofpostpartumhemorrhageresultsfromarandomizedplacebocontrolledtrialconductedinbadakhshanprovinceafghanistan
AT mirzazadashafiq testingahomebasedmodelofcareusingmisoprostolforpreventionandtreatmentofpostpartumhemorrhageresultsfromarandomizedplacebocontrolledtrialconductedinbadakhshanprovinceafghanistan
AT durocherjill testingahomebasedmodelofcareusingmisoprostolforpreventionandtreatmentofpostpartumhemorrhageresultsfromarandomizedplacebocontrolledtrialconductedinbadakhshanprovinceafghanistan
AT pamirishahfaqir testingahomebasedmodelofcareusingmisoprostolforpreventionandtreatmentofpostpartumhemorrhageresultsfromarandomizedplacebocontrolledtrialconductedinbadakhshanprovinceafghanistan
AT byrnemeagane testingahomebasedmodelofcareusingmisoprostolforpreventionandtreatmentofpostpartumhemorrhageresultsfromarandomizedplacebocontrolledtrialconductedinbadakhshanprovinceafghanistan
AT winikoffbeverly testingahomebasedmodelofcareusingmisoprostolforpreventionandtreatmentofpostpartumhemorrhageresultsfromarandomizedplacebocontrolledtrialconductedinbadakhshanprovinceafghanistan