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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.

ABSTRACT: 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.

SUBMITTER: Abbas DF

PROVIDER: S-EPMC7275481 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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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 DF Mirzazada Shafiq S Durocher Jill J Pamiri Shahfaqir S Byrne Meagan E ME Winikoff Beverly B

Reproductive health 20200605 1

<h4>Background</h4>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.<h4>Methods</h4>A double-blind, rando ...[more]

PMID: 32503556

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Project description:Postpartum hemorrhage (PPH) is a leading cause of maternal death in sub-Saharan Africa. Although the World Health Organization recommends use of oxytocin for prevention of PPH, misoprostol use is increasingly common owing to advantages in shelf life and potential for sublingual administration. There is a lack of data about the comparative efficacy of oxytocin and sublingual misoprostol, particularly at the recommended dose of 600 µg, for prevention of PPH during active management of labor.We performed a double-blind, double-dummy randomized controlled non-inferiority trial between 23 September 2012 and 9 September 2013 at Mbarara Regional Referral Hospital in Uganda. We randomized 1,140 women to receive 600 µg of misoprostol sublingually or 10 IU of oxytocin intramuscularly, along with matching placebos for the treatment they did not receive. Our primary outcome of interest was PPH, defined as measured blood loss ? 500 ml within 24 h of delivery. Secondary outcomes included measured blood loss ? 1,000 ml; mean measured blood loss at 1, 2, and 24 h after delivery; death; requirement for blood transfusion; hemoglobin changes; and use of additional uterotonics. At 24 h postpartum, primary PPH occurred in 163 (28.6%) participants in the misoprostol group and 99 (17.4%) participants in the oxytocin group (relative risk [RR] 1.64, 95% CI 1.32 to 2.05, p<0.001; absolute risk difference 11.2%, 95% CI 6.44 to 16.1). Severe PPH occurred in 20 (3.6%) and 15 (2.7%) participants in the misoprostol and oxytocin groups, respectively (RR 1.33, 95% CI 0.69 to 2.58, p = 0.391; absolute risk difference 0.9%, 95% CI -1.12 to 2.88). Mean measured blood loss was 341.5 ml (standard deviation [SD] 206.2) and 304.2 ml (SD 190.8, p = 0.002) at 2 h and 484.7 ml (SD 213.3) and 432.8 ml (SD 203.5, p<0.001) at 24 h in the misoprostol and oxytocin groups, respectively. There were no significant differences between the two groups in any other secondary outcomes. Women in the misoprostol group more commonly experienced shivering (RR 1.91, 95% CI 1.65 to 2.21, p<0.001) and fevers (RR 5.20, 95% CI 3.15 to 7.21, p = 0.005). This study was conducted at a regional referral hospital with capacity for emergency surgery and blood transfusion. High-risk women were excluded from participation.Misoprostol 600 µg is inferior to oxytocin 10 IU for prevention of primary PPH in active management of labor. These data support use of oxytocin in settings where it is available. While not powered to do so, the study found no significant differences in rate of severe PPH, need for blood transfusion, postpartum hemoglobin, change in hemoglobin, or use of additional uterotonics between study groups. Further research should focus on clarifying whether and in which sub-populations use of oxytocin would be preferred over sublingual misoprostol.ClinicalTrials.gov NCT01866241 Please see later in the article for the Editors' Summary.

Project description:BackgroundHemorrhage is the leading cause of maternal mortality worldwide and accounts for 56% of maternal deaths in Afghanistan. Postpartum hemorrhage (PPH) is commonly caused by uterine atony, genital tract trauma, retained placenta, and coagulation disorders. The purpose of this study is to examine the quality of prevention, detection and management of PPH in both public and private hospitals in Afghanistan in 2016, and compare the quality of care in district hospitals with care in provincial, regional, and specialty hospitals.MethodsThis study uses a subset of data from the 2016 Afghanistan National Maternal and Newborn Health Quality of Care Assessment. It covers a census of all accessible public hospitals, including 40 district hospitals, 27 provincial hospitals, five regional hospitals, and five specialty hospitals, as well as 10 purposively selected private hospitals.ResultsAll public and private hospitals reported 24?h/7?days a week service provision. Oxytocin was available in 90.0% of district hospitals, 89.2% of provincial, regional and specialty hospitals and all 10 private hospitals; misoprostol was available in 52.5% of district hospitals, 56.8% of provincial, regional and specialty hospitals and in all 10 private hospitals. For prevention of PPH, 73.3% women in district hospitals, 71.2% women at provincial, regional and specialty hospitals and 72.7% women at private hospital received uterotonics. Placenta and membranes were checked for completeness in almost half of women in all hospitals. Manual removal of placenta was performed in 97.8% women with retained placenta. Monitoring blood loss during the immediate postpartum period was performed in 48.4% of women in district hospitals, 36.9% of women in provincial, regional and specialty hospitals, and 43.3% in private hospitals. The most commonly observed cause of PPH was retained placenta followed by genital tract trauma and uterine atony.ConclusionGaps in performance of skilled birth attendants are substantial across public and private hospitals. Improving and retaining skills of health workers through on-site, continuous capacity development approaches and encouraging a culture of audit, learning and quality improvement may address clinical gaps and improve quality of PPH prevention, detection and management.

Project description:BackgroundPostpartum hemorrhage (PPH) and the amount of blood loss are directly related to management of the third stage of labor. No previous report has compared the effects of carbetocin to those of misoprostol. The aim of this systematic review was to compare the effects of carbetocin to those of misoprostol for management of the third stage of labor and for the prevention of PPH.MethodsWe searched the Cochrane Library (Central), Web of Science, Scopus, Science Direct, Ovid, clinicaltrial.gov , and PubMed databases on December 28, 2017. Data extraction and risk of bias assessment were performed by 2 of the authors independently. Individual and pooled incidences were calculated for the included studies, with 95% confidence intervals (CIs). We used a fixed model for forest plots without heterogeneity and a random effect model for those with heterogeneity.ResultsOur search identified 117 studies; however, 29 studies were duplicate. Of the 88 non-duplicate studies, 5 met the inclusion criteria. Of these five studies, two are currently underway. Hence, three studies were finally included in our meta-analysis. The pooled estimate of the impact of carbetocin on PPH (500-1000 ml) was (OR 0.27, 95% CI 0.14-0.50). Carbetocin significantly reduced the need for additional uterotonics (RR 0.28, 95% CI 0.15 to 0.49). Reduction in the hemoglobin level and blood loss during the third stage of labor was significantly lower in women who received carbetocin than in those who received misoprostol. The length of the third stage of labor was significantly lower in women who received carbetocin than in those who received misoprostol. The incidence of side effects, such as heat sensation, metallic taste, fever, and shivering, were significantly lower in women who received carbetocin than in those who received misoprostol.ConclusionAlthough this review showed that carbetocin is effective for decreasing PPH, blood loss, the length of the third stage of labor, and the need for additional uterotonics, this conclusion should be considered with caution. Because assessment of PPH is a subjective issue and it is uncertain whether outcomes were assessed blindly in respect to treatment. We recommend future research to verify our findings. Also clinicians may like to consider use of carbetocin for women with low risk for PPH.

Project description: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.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.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 misoprostolA 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.Clinical trials.gov, Registry No. NCT00116480.

Project description:ObjectiveTo assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis.DesignA cluster-randomised non-inferiority community trial.SettingHealth sub-centres and home deliveries in the Bijapur district of Karnataka, India.PopulationWomen with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study.MethodsAuxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.Main outcome measuresPostpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention.ResultsMisoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference -2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).ConclusionSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.Tweetable abstractSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis.

Dataset Information

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.

Publications

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.

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