Gynuity Health Projects, 220 East 42nd Street Suite 710, New York, NY, 10017, USA.
Academic Projects Afghanistan, Aga Khan University, Co French Medical Institute for Children, Ali Abad, Kabul, Afghanistan.
Reprod Health. 2020 Jun 5;17(1):88. doi: 10.1186/s12978-020-00933-8.
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.
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.
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.
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.
This trial was registered with ClinicalTrials.gov, number NCT01508429 Registered on December 1, 2011.
产后出血（PPH）是全球产妇死亡的主要原因。在阿富汗，大多数分娩都是在家中进行的，没有熟练的接生员的帮助，因此需要在社区环境中管理 PPH 的选择方案。米索前列醇是一种缩宫素，已在家中作为预防措施使用，并且已被证明在医院环境中治疗 PPH 也有效，这是一种可能的选择。
在阿富汗巴达赫尚省的六个地区进行了一项双盲、随机安慰剂对照试验，以测试在家分娩后给予 800mcg 舌下米索前列醇治疗产后大量出血对妇女的有效性和安全性。在分娩前同意的妇女被纳入研究并给予 600mcg 米索前列醇口服自行预防。社区卫生工作者（CHW）接受了培训，以便在分娩后观察 PPH 的迹象，如果诊断出 PPH，则给予研究药物（米索前列醇或安慰剂）并立即转介该妇女。血红蛋白（Hb）下降 2g/dL 或更多，测量分娩前和分娩后，作为主要结局；还分析了副作用、其他干预措施和转移率。
在在家分娩的 1884 名妇女中，几乎所有（98.7%）报告使用米索前列醇预防 PPH。一小部分被诊断患有 PPH（4.4%，82/1884）并接受了治疗。研究组之间的 Hb 结局（包括 Hb 下降 2g/dL 或更多的妇女比例）相似（米索前列醇：56.4%（22/39），安慰剂：60.6%（20/33），p=0.45）。随机接受米索前列醇治疗的妇女中，明显更多的妇女出现颤抖（82.5%比安慰剂：61.5%，p=0.03）。研究组之间的其他副作用相似，不需要治疗，包括在接受米索前列醇治疗 PPH 的两种适应症的 39 名妇女的亚组中。
虽然该研究没有记录与米索前列醇治疗 PPH 相关的临床益处，但研究结果表明，在家分娩中同时用于预防和治疗以及由非专业人员使用米索前列醇不会引起任何安全问题。
本试验在 ClinicalTrials.gov 注册，编号为 NCT01508429，于 2011 年 12 月 1 日注册。
