Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial

Ayisha Diop; Bocar Daff; Maimouna Sow; Jennifer Blum; Mamadou Diagne; Nancy L Sloan; Beverly Winikoff

摘要

Summary BackgroundAccess to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts.MethodsWe did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxiliary midwives located 3–21 km from the closest referral centre were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity Health Projects) to either 600 μg oral misoprostol or 10 IU oxytocin in Uniject (intramuscular), stratified by reported previous year clinic volume (deliveries) and geographical location (inland or coastal). Maternity huts that had been included in a previous study of misoprostol for prevention of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their third trimester were screened for eligibility either during community outreach or at home-based prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were eligible for the study. Women with known allergies to prostaglandins or pregnancy complications were excluded. The primary outcome was mean change in haemoglobin concentration measured during the third trimester and after delivery. This study was registered with ClinicalTrials.gov , number NCT01713153 .Findings28 maternity hut clusters were randomly assigned—14 to the misoprostol group and 14 to the oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647 women in the misoprostol group and 402 in the oxytocin group received study drug and had recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women delivered in the study maternity huts. The mean change in haemoglobin concentrations was 3·5 g/L (SD 16·1) in the misoprostol group and 2·7 g/L (SD 17·8) in the oxytocin group. When adjusted for cluster design, the mean difference in haemoglobin decreases between groups was not significant (0·3 g/L, 95% CI ?8·26 to 8·92, p=0·71). Both drugs were well tolerated. Shivering was common in the misoprostol group, and nausea in the oxytocin group. Postpartum haemorrhage was diagnosed in one woman allocated to oxytocin, who was referred and transferred to a higher-level facility for additional care, and fully recovered. No other women were transferred.InterpretationIn terms of effects on haemoglobin concentrations, neither oxytocin nor misoprostol was significantly better than the other, and both drugs were safe and efficacious when delivered by auxiliary midwives. The programmatic limitations of oxytocin, including short shelf life outside the cold chain, mean that misoprostol could be more appropriate for community-level prophylaxis of postpartum haemorrhage.FundingBill & Melinda Gates Foundation. prs.rt("abs_end"); Introduction Despite substantial progress since 1990, Senegal's maternal mortality rate of 320 per 100?000 livebirths in 2013 is still almost double its UNDP Millennium Development Goal target of 168 deaths per 100?000 livebirths. 1 Postpartum haemorrhage is the main cause of maternal mortality in Senegal: it accounts for more than 29% of maternal deaths. 2 Only around 50% of deliveries in the country (37% in rural areas) are attended by skilled personnel qualified to prevent or treat obstetric complications. 3 Additionally, lack of available trained personnel in rural areas and transport constraints make standard injectable uterotonics for the prevention and treatment of postpartum haemorrhage difficult to access. 4 Uterotonics effectively reduce the frequency of postpartum haemorrhage. 5 and 6 Studies done in well resourced hospital settings show that oxytocin prophylaxis is associated with less postpartum blood loss than is misoprostol prophylaxis. 7 and 8 However, oxytocin is not always feasible—and might be less effective—in resource-poor settings: cool storage is necessary, and because it is given by injection, sterile equipment and skilled personnel are essential. 9 Misoprostol is a safe and effective alternative, 10 and is recommended for use in settings where injectable uterotonics are neither available nor feasible. 11 Results of community-based studies have shown that misoprostol is associated with significant reductions in blood loss 12 and 13 and suggest that the drug could improve maternal outcomes when community-level providers are involved. 14 Research in context Evidence before this study Both misoprostol and oxytocin delivered via Uniject (a prefilled, easy-to-use, single dose of oxytocin) effectively prevent postpartum haemorrhage, and, in 2011, WHO added both to its essential medicines list for this i

机译：概述背景塞内加尔外部医疗机构对可注射子宫内避孕药进行管理以控制产后出血仍然受到限制，通过Uniject递送的米索前列醇和催产素在社区环境中被认为是可行的选择。我们旨在比较辅助助产士在产妇小屋中提供这些药物的疗效。方法我们在塞内加尔三个地区的产妇小屋中进行了无掩盖的整群随机对照试验。距离最近的转诊中心3–21 km处有辅助助产士的产妇小屋被随机分配（1：1;通过由Gynuity Health Projects监督的计算机生成的随机分配）分配给Uniject（肌注）中的600μg口服米索前列醇或10 IU催产素），按上一年报告的诊所数量（送诊）和地理位置（内陆或沿海）进行分层。以前的米索前列醇研究防止产后出血的产妇小屋被排除在外，以防止污染。在社区外展期间或在家中进行产前检查时，对妊娠中期的孕妇进行筛查。只有在产妇小屋由辅助助产士分娩的妇女才有资格参加研究。排除对前列腺素过敏或妊娠并发症的女性。主要结果是在妊娠中期和分娩后测得的血红蛋白浓度的平均变化。这项研究已在ClinicalTrials.gov上注册，编号为NCT01713153。研究结果随机分配了28个孕妇小屋群集-米索前列醇组为14个，催产素组为14个。从2012年6月6日到2013年9月21日，招募了1820名女性。米索前列醇组中的647名妇女和催产素组中的402名妇女接受了研究药物，并记录了分娩前和分娩后的血红蛋白浓度，总共有1412名妇女在研究分娩小屋中分娩。米索前列醇组的血红蛋白浓度平均变化为3·5 g / L（SD 16·1），催产素组的平均血红蛋白浓度变化为2·7 g / L（SD 17·8）。调整群集设计后，两组之间血红蛋白下降的平均差异不显着（0·3 g / L，95％CI≤8·26至8·92，p = 0·71）。两种药物均耐受良好。在米索前列醇组中颤抖是常见的，在催产素组中是恶心的。一名产于催产素的妇女被诊断出产后出血，该妇女被转诊并转移到上级机构接受进一步护理，并已完全康复。没有其他妇女被转移。解释从对血红蛋白浓度的影响来看，催产素和米索前列醇均没有明显优于另一种，并且当由辅助助产士分娩时，这两种药物都是安全有效的。催产素的程序性局限性，包括冷链外的保质期短，意味着米索前列醇可能更适合社区一级预防产后出血。FillingBill＆Melinda Gates Foundation。 prs.rt（“ abs_end”）;引言尽管自1990年以来取得了长足的进步，塞内加尔的孕产妇死亡率在2013年为每10万名活产婴儿320例，但仍几乎是其开发计划署《千年发展目标》指标每100000活产婴儿168例死亡的两倍。 1 产后出血是塞内加尔孕产妇死亡的主要原因：它占孕产妇死亡的29％以上。 2 在该国，只有大约50％的分娩（农村地区为37％）有资格预防或治疗产科并发症的熟练人员参加。 3 另外，由于农村地区缺少训练有素的人员，并且交通运输受到限制，因此很难获得用于预防和治疗产后出血的标准可注射子宫内避孕药。 4 子宫内避孕药有效地减少了产后出血的频率。 5和6 在资源丰富的医院中进行的研究表明，催产素的预防与产后出血相比，米索前列醇的预防较少。 7和8 但是，催产素在资源匮乏的环境中并不总是可行的，并且效果可能较差：必须冷藏，而且由于是注射给药，因此无菌设备和熟练的人员必不可少。 9 米索前列醇是一种安全有效的替代品， 10 ，推荐用于无法使用注射型子宫内贴剂的场合。 11 社区研究的结果表明，米索前列醇与失血量的显着减少有关 12和13 ，并表明当社区水平的提供者使用该药物可以改善孕产妇的结局参与其中。 14 背景研究这项研究之前的证据通过Uniject（一种预先填充的，易于使用的单剂量催产素）提供的米索前列醇和催产素都可以有效地预防产后出血，并且在2011年，世卫组织增加了两者它的基本药物清单为此我

Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial

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