Misoprostol as an adjunct to standard uterotonics for treatment of post-partum haemorrhage: a multicentre, double-blind randomised trial
Summary Background Post-partum haemorrhage is a leading cause of global maternal morbidity and mortality. Misoprostol, a prostaglandin analogue with uterotonic activity, is an attractive option for treatment because it is stable, active orally, and inexpensive. We aimed to assess the effectiveness o...
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| Veröffentlicht in: | The Lancet (British edition) 2010-05, Vol.375 (9728), p.1808-1813 |
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| creator | Widmer, Mariana, MSc Blum, Jennifer, MPH Hofmeyr, G Justus, MD Carroli, Guillermo, MD Abdel-Aleem, Hany, Prof Lumbiganon, Pisake, Prof Ngoc, Nguyen Thi Nhu, MD Wojdyla, Daniel, MSc Thinkhamrop, Jadsada, Prof Singata, Mandisa, RN/RM Mignini, Luciano E, MD Abdel-Aleem, Mahmoud Ahmad, MD Thach, Tran Son, MD Winikoff, Beverly, MD |
| description | Summary Background Post-partum haemorrhage is a leading cause of global maternal morbidity and mortality. Misoprostol, a prostaglandin analogue with uterotonic activity, is an attractive option for treatment because it is stable, active orally, and inexpensive. We aimed to assess the effectiveness of misoprostol as an adjunct to standard uterotonics compared with standard uterotonics alone for treatment of post-partum haemorrhage. Methods Women delivering vaginally who had clinically diagnosed post-partum haemorrhage due to uterine atony were enrolled from participating hospitals in Argentina, Egypt, South Africa, Thailand, and Vietnam between July, 2005, and August, 2008. Computer-generated randomisation was used to assign women to receive 600 μg misoprostol or matching placebo sublingually; both groups were also given routine injectable uterotonics. Allocation was concealed by distribution of sealed and sequentially numbered treatment packs in the order that women were enrolled. Providers and women were masked to treatment assignment. The primary outcome was blood loss of 500 mL or more within 60 min after randomisation. Analysis was by intention to treat. This study is registered, number ISRCTN34455240. Findings 1422 women were assigned to receive misoprostol (n=705) or placebo (n=717). The proportion of women with blood loss of 500 mL or more within 60 min was similar between the misoprostol group (100 [14%]) and the placebo group (100 [14%]; relative risk 1·02, 95% CI 0·79–1·32). In the first 60 min, an increased proportion of women on misoprostol versus placebo, had shivering (455/704 [65%] vs 230/717 [32%]; 2·01, 1·79–2·27) and body temperature of 38°C or higher (303/704 [43%] vs 107/717 [15%]; 2·88, 2·37–2·50). Interpretation Findings from this study do not support clinical use of 600 μg sublingual misoprostol in addition to standard injectable uterotonics for treatment of post-partum haemorrhage. Funding Bill & Melinda Gates Foundation, and UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. |
| doi_str_mv | 10.1016/S0140-6736(10)60348-0 |
| format | Article |
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Misoprostol, a prostaglandin analogue with uterotonic activity, is an attractive option for treatment because it is stable, active orally, and inexpensive. We aimed to assess the effectiveness of misoprostol as an adjunct to standard uterotonics compared with standard uterotonics alone for treatment of post-partum haemorrhage. Methods Women delivering vaginally who had clinically diagnosed post-partum haemorrhage due to uterine atony were enrolled from participating hospitals in Argentina, Egypt, South Africa, Thailand, and Vietnam between July, 2005, and August, 2008. Computer-generated randomisation was used to assign women to receive 600 μg misoprostol or matching placebo sublingually; both groups were also given routine injectable uterotonics. Allocation was concealed by distribution of sealed and sequentially numbered treatment packs in the order that women were enrolled. Providers and women were masked to treatment assignment. The primary outcome was blood loss of 500 mL or more within 60 min after randomisation. Analysis was by intention to treat. This study is registered, number ISRCTN34455240. Findings 1422 women were assigned to receive misoprostol (n=705) or placebo (n=717). The proportion of women with blood loss of 500 mL or more within 60 min was similar between the misoprostol group (100 [14%]) and the placebo group (100 [14%]; relative risk 1·02, 95% CI 0·79–1·32). In the first 60 min, an increased proportion of women on misoprostol versus placebo, had shivering (455/704 [65%] vs 230/717 [32%]; 2·01, 1·79–2·27) and body temperature of 38°C or higher (303/704 [43%] vs 107/717 [15%]; 2·88, 2·37–2·50). Interpretation Findings from this study do not support clinical use of 600 μg sublingual misoprostol in addition to standard injectable uterotonics for treatment of post-partum haemorrhage. Funding Bill & Melinda Gates Foundation, and UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(10)60348-0</identifier><identifier>PMID: 20494730</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adult ; Biological and medical sciences ; Blood ; Body temperature ; Clinical trials ; Double-Blind Method ; Female ; General aspects ; Hemophilia ; Hospitals ; Humans ; Internal Medicine ; Labor Stage, Third ; Maternal mortality ; Medical sciences ; Misoprostol ; Misoprostol - therapeutic use ; Oxytocics ; Oxytocics - therapeutic use ; Postpartum Hemorrhage ; Postpartum Hemorrhage - drug therapy ; Pregnancy ; R&D ; Research & development ; Risk</subject><ispartof>The Lancet (British edition), 2010-05, Vol.375 (9728), p.1808-1813</ispartof><rights>Elsevier Ltd</rights><rights>2010 Elsevier Ltd</rights><rights>World Bank</rights><rights>2015 INIST-CNRS</rights><rights>Copyright 2010 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited May 22-May 28, 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c6044-801abb6310a8c854626ae24925856ff8bebd4e281648e8b482c3dae51123e0413</citedby><cites>FETCH-LOGICAL-c6044-801abb6310a8c854626ae24925856ff8bebd4e281648e8b482c3dae51123e0413</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673610603480$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,18961,27901,27902,65306</link.rule.ids><linktorsrc>$$Uhttps://hdl.handle.net/10986/5154$$EView_record_in_World_Bank$$FView_record_in_$$GWorld_Bank</linktorsrc><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22829156$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20494730$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Widmer, Mariana, MSc</creatorcontrib><creatorcontrib>Blum, Jennifer, MPH</creatorcontrib><creatorcontrib>Hofmeyr, G Justus, MD</creatorcontrib><creatorcontrib>Carroli, Guillermo, MD</creatorcontrib><creatorcontrib>Abdel-Aleem, Hany, Prof</creatorcontrib><creatorcontrib>Lumbiganon, Pisake, Prof</creatorcontrib><creatorcontrib>Ngoc, Nguyen Thi Nhu, MD</creatorcontrib><creatorcontrib>Wojdyla, Daniel, MSc</creatorcontrib><creatorcontrib>Thinkhamrop, Jadsada, Prof</creatorcontrib><creatorcontrib>Singata, Mandisa, RN/RM</creatorcontrib><creatorcontrib>Mignini, Luciano E, MD</creatorcontrib><creatorcontrib>Abdel-Aleem, Mahmoud Ahmad, MD</creatorcontrib><creatorcontrib>Thach, Tran Son, MD</creatorcontrib><creatorcontrib>Winikoff, Beverly, MD</creatorcontrib><title>Misoprostol as an adjunct to standard uterotonics for treatment of post-partum haemorrhage: a multicentre, double-blind randomised trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background Post-partum haemorrhage is a leading cause of global maternal morbidity and mortality. Misoprostol, a prostaglandin analogue with uterotonic activity, is an attractive option for treatment because it is stable, active orally, and inexpensive. We aimed to assess the effectiveness of misoprostol as an adjunct to standard uterotonics compared with standard uterotonics alone for treatment of post-partum haemorrhage. Methods Women delivering vaginally who had clinically diagnosed post-partum haemorrhage due to uterine atony were enrolled from participating hospitals in Argentina, Egypt, South Africa, Thailand, and Vietnam between July, 2005, and August, 2008. Computer-generated randomisation was used to assign women to receive 600 μg misoprostol or matching placebo sublingually; both groups were also given routine injectable uterotonics. Allocation was concealed by distribution of sealed and sequentially numbered treatment packs in the order that women were enrolled. Providers and women were masked to treatment assignment. The primary outcome was blood loss of 500 mL or more within 60 min after randomisation. Analysis was by intention to treat. This study is registered, number ISRCTN34455240. Findings 1422 women were assigned to receive misoprostol (n=705) or placebo (n=717). The proportion of women with blood loss of 500 mL or more within 60 min was similar between the misoprostol group (100 [14%]) and the placebo group (100 [14%]; relative risk 1·02, 95% CI 0·79–1·32). In the first 60 min, an increased proportion of women on misoprostol versus placebo, had shivering (455/704 [65%] vs 230/717 [32%]; 2·01, 1·79–2·27) and body temperature of 38°C or higher (303/704 [43%] vs 107/717 [15%]; 2·88, 2·37–2·50). Interpretation Findings from this study do not support clinical use of 600 μg sublingual misoprostol in addition to standard injectable uterotonics for treatment of post-partum haemorrhage. Funding Bill & Melinda Gates Foundation, and UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.</description><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Blood</subject><subject>Body temperature</subject><subject>Clinical trials</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>General aspects</subject><subject>Hemophilia</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Labor Stage, Third</subject><subject>Maternal mortality</subject><subject>Medical sciences</subject><subject>Misoprostol</subject><subject>Misoprostol - therapeutic use</subject><subject>Oxytocics</subject><subject>Oxytocics - therapeutic use</subject><subject>Postpartum Hemorrhage</subject><subject>Postpartum Hemorrhage - drug therapy</subject><subject>Pregnancy</subject><subject>R&D</subject><subject>Research & 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as an adjunct to standard uterotonics for treatment of post-partum haemorrhage: a multicentre, double-blind randomised trial</title><author>Widmer, Mariana, MSc ; Blum, Jennifer, MPH ; Hofmeyr, G Justus, MD ; Carroli, Guillermo, MD ; Abdel-Aleem, Hany, Prof ; Lumbiganon, Pisake, Prof ; Ngoc, Nguyen Thi Nhu, MD ; Wojdyla, Daniel, MSc ; Thinkhamrop, Jadsada, Prof ; Singata, Mandisa, RN/RM ; Mignini, Luciano E, MD ; Abdel-Aleem, Mahmoud Ahmad, MD ; Thach, Tran Son, MD ; Winikoff, Beverly, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c6044-801abb6310a8c854626ae24925856ff8bebd4e281648e8b482c3dae51123e0413</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Blood</topic><topic>Body temperature</topic><topic>Clinical trials</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>General aspects</topic><topic>Hemophilia</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Labor Stage, Third</topic><topic>Maternal mortality</topic><topic>Medical sciences</topic><topic>Misoprostol</topic><topic>Misoprostol - therapeutic use</topic><topic>Oxytocics</topic><topic>Oxytocics - therapeutic use</topic><topic>Postpartum Hemorrhage</topic><topic>Postpartum Hemorrhage - drug therapy</topic><topic>Pregnancy</topic><topic>R&D</topic><topic>Research & development</topic><topic>Risk</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Widmer, Mariana, MSc</creatorcontrib><creatorcontrib>Blum, Jennifer, MPH</creatorcontrib><creatorcontrib>Hofmeyr, G Justus, MD</creatorcontrib><creatorcontrib>Carroli, Guillermo, MD</creatorcontrib><creatorcontrib>Abdel-Aleem, Hany, Prof</creatorcontrib><creatorcontrib>Lumbiganon, Pisake, Prof</creatorcontrib><creatorcontrib>Ngoc, Nguyen Thi Nhu, 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MD</au><au>Abdel-Aleem, Hany, Prof</au><au>Lumbiganon, Pisake, Prof</au><au>Ngoc, Nguyen Thi Nhu, MD</au><au>Wojdyla, Daniel, MSc</au><au>Thinkhamrop, Jadsada, Prof</au><au>Singata, Mandisa, RN/RM</au><au>Mignini, Luciano E, MD</au><au>Abdel-Aleem, Mahmoud Ahmad, MD</au><au>Thach, Tran Son, MD</au><au>Winikoff, Beverly, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Misoprostol as an adjunct to standard uterotonics for treatment of post-partum haemorrhage: a multicentre, double-blind randomised trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2010-05-22</date><risdate>2010</risdate><volume>375</volume><issue>9728</issue><spage>1808</spage><epage>1813</epage><pages>1808-1813</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background Post-partum haemorrhage is a leading cause of global maternal morbidity and mortality. Misoprostol, a prostaglandin analogue with uterotonic activity, is an attractive option for treatment because it is stable, active orally, and inexpensive. We aimed to assess the effectiveness of misoprostol as an adjunct to standard uterotonics compared with standard uterotonics alone for treatment of post-partum haemorrhage. Methods Women delivering vaginally who had clinically diagnosed post-partum haemorrhage due to uterine atony were enrolled from participating hospitals in Argentina, Egypt, South Africa, Thailand, and Vietnam between July, 2005, and August, 2008. Computer-generated randomisation was used to assign women to receive 600 μg misoprostol or matching placebo sublingually; both groups were also given routine injectable uterotonics. Allocation was concealed by distribution of sealed and sequentially numbered treatment packs in the order that women were enrolled. Providers and women were masked to treatment assignment. The primary outcome was blood loss of 500 mL or more within 60 min after randomisation. Analysis was by intention to treat. This study is registered, number ISRCTN34455240. Findings 1422 women were assigned to receive misoprostol (n=705) or placebo (n=717). The proportion of women with blood loss of 500 mL or more within 60 min was similar between the misoprostol group (100 [14%]) and the placebo group (100 [14%]; relative risk 1·02, 95% CI 0·79–1·32). In the first 60 min, an increased proportion of women on misoprostol versus placebo, had shivering (455/704 [65%] vs 230/717 [32%]; 2·01, 1·79–2·27) and body temperature of 38°C or higher (303/704 [43%] vs 107/717 [15%]; 2·88, 2·37–2·50). Interpretation Findings from this study do not support clinical use of 600 μg sublingual misoprostol in addition to standard injectable uterotonics for treatment of post-partum haemorrhage. Funding Bill & Melinda Gates Foundation, and UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>20494730</pmid><doi>10.1016/S0140-6736(10)60348-0</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext_linktorsrc |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2010-05, Vol.375 (9728), p.1808-1813 |
| issn | 0140-6736 1474-547X |
| language | eng |
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| source | Open Knowledge Repository |
| subjects | Adult Biological and medical sciences Blood Body temperature Clinical trials Double-Blind Method Female General aspects Hemophilia Hospitals Humans Internal Medicine Labor Stage, Third Maternal mortality Medical sciences Misoprostol Misoprostol - therapeutic use Oxytocics Oxytocics - therapeutic use Postpartum Hemorrhage Postpartum Hemorrhage - drug therapy Pregnancy R&D Research & development Risk |
| title | Misoprostol as an adjunct to standard uterotonics for treatment of post-partum haemorrhage: a multicentre, double-blind randomised trial |
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