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Misoprostol in addition to routine treatment of postpartum hemorrhage: A hospital-based randomized-controlled trial in Karachi, Pakistan

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      Abstract

      Background

      Postpartum hemorrhage (PPH) remains a major killer of women worldwide. Standard uterotonic treatments used to control postpartum bleeding do not always work and are not always available. Misoprostol's potential as a treatment option for PPH is increasingly known, but its use remains ad hoc and available evidence does not support the safety or efficacy of one particular regimen. This study aimed to determine the adjunct benefit of misoprostol when combined with standard oxytocics for PPH treatment.

      Methods

      A randomized controlled trial was conducted in four Karachi hospitals from December 2005 – April 2007 to assess the benefit of a 600 mcg dose of misoprostol given sublingually in addition to standard oxytocics for postpartum hemorrhage treatment. Consenting women had their blood loss measured after normal vaginal delivery and were enrolled in the study after losing more than 500 ml of blood. Women were randomly assigned to receive either 600 mcg sublingual misoprostol or matching placebo in addition to standard PPH treatment with injectable oxytocics. Both women and providers were blinded to the treatment assignment. Blood loss was collected until active bleeding stopped and for a minimum of one hour after PPH diagnosis. Total blood loss, hemoglobin measures, and treatment outcomes were recorded for all participants.

      Results

      Due to a much lower rate of PPH than expected (1.2%), only sixty-one patients were diagnosed and treated for their PPH in this study, and we were therefore unable to measure statistical significance in any of the primary endpoints. The addition of 600 mcg sublingual misoprostol to standard PPH treatments does, however, suggest a trend in reduced postpartum blood loss, a smaller drop in postpartum hemoglobin, and need for fewer additional interventions. Women who bled less overall had a significantly smaller drop in hemoglobin and received fewer additional interventions. There were no hysterectomies or maternal deaths among study participants. The rate of transient shivering and fever was significantly higher among women receiving misoprostol

      Conclusion

      A 600 mcg dose of misoprostol given sublingually shows promise as an adjunct treatment for PPH and its use should continue to be explored for its life-saving potential in the care of women experiencing PPH.

      Trial Registration

      Clinical trials.gov, Registry No. NCT00116480

      Related collections

      Most cited references 24

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      Estimates of maternal mortality worldwide between 1990 and 2005: an assessment of available data.

      Maternal mortality, as a largely avoidable cause of death, is an important focus of international development efforts, and a target for Millennium Development Goal (MDG) 5. However, data weaknesses have made monitoring progress problematic. In 2006, a new maternal mortality working group was established to develop improved estimation methods and make new estimates of maternal mortality for 2005, and to analyse trends in maternal mortality since 1990. We developed and used a range of methods, depending on the type of data available, to produce comparable country, regional, and global estimates of maternal mortality ratios for 2005 and to assess trends between 1990 and 2005. We estimate that there were 535,900 maternal deaths in 2005, corresponding to a maternal mortality ratio of 402 (uncertainty bounds 216-654) deaths per 100,000 livebirths. Most maternal deaths in 2005 were concentrated in sub-Saharan Africa (270,500, 50%) and Asia (240,600, 45%). For all countries with data, there was a decrease of 2.5% per year in the maternal mortality ratio between 1990 and 2005 (p<0.0001); however, there was no evidence of a significant reduction in maternal mortality ratios in sub-Saharan Africa in the same period. Although some regions have shown some progress since 1990 in reducing maternal deaths, maternal mortality ratios in sub-Saharan Africa have remained very high, with little evidence of improvement in the past 15 years. To achieve MDG5 targets by 2015 will require sustained and urgent emphasis on improved pregnancy and delivery care throughout the developing world.
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        Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

        Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting. In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123. Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control. Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.
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          Drape estimation vs. visual assessment for estimating postpartum hemorrhage.

          To compare (1) visual estimation of postpartum blood loss with estimation using a specifically designed blood collection drape and (2) the drape estimate with a measurement of blood loss by photospectrometry. A randomized controlled study was performed with 123 women delivered at the District Hospital, Belgaum, India. The women were randomized to visual or drape estimation of blood loss. A subsample of 10 drape estimates was compared with photospectrometry results. The visual estimate of blood loss was 33% less than the drape estimate. The interclass correlation of the drape estimate to photospectrometry measurement was 0.92. Drape estimation of blood loss is more accurate than visual estimation and may have particular utility in the developing world. Prompt detection of postpartum hemorrhage may reduce maternal morbidity and mortality in low-resource settings.
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            Author and article information

            Affiliations
            [1 ]The Aga Khan University, Dept. of Obstetrics & Gynecology, Karachi, Pakistan
            [2 ]Gynuity Health Projects, New York, USA
            [3 ]The Aga Khan University Hospital, Dept. of Obstetrics & Gynecology, Karachi, Pakistan
            [4 ]Aga Khan Health Services, Dept. of Obstetrics & Gynecology, Karachi, Pakistan
            [5 ]Secretariat of His Highness the Aga Khan, Aiglemont, France; The Aga Khan University, Dept. of Community Health Sciences, Karachi, Pakistan
            Contributors
            Journal
            BMC Pregnancy Childbirth
            BMC Pregnancy and Childbirth
            BioMed Central
            1471-2393
            2008
            21 August 2008
            : 8
            : 40
            2529259
            1471-2393-8-40
            18718007
            10.1186/1471-2393-8-40
            Copyright © 2008 Zuberi et al; licensee BioMed Central Ltd.

            This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

            Categories
            Research Article

            Obstetrics & Gynecology

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