缩宫素与米索前列醇联合用于第三产程的积极管理以预防产后出血：一项随机对照试验
Active Management of the Third Stage of Labor With a Combination of Oxytocin and Misoprostol to Prevent Postpartum Hemorrhage: A Randomized Controlled Trial.
作者信息
Quibel Thibaud, Ghout Idir, Goffinet François, Salomon Laurent J, Fort Julie, Javoise Sophie, Bussieres Laurence, Aegerter Philippe, Rozenberg Patrick
机构信息
Department of Obstetrics and Gynecology, Poissy-Saint Germain Hospital, Versailles-Saint Quentin University, research unit EA 7285, Versailles, the Department of Clinical Research Paris Ouest, Ambroise Paré Hospital, Assistance Publique-Hôpitaux de Paris, Boulogne, the Departments of Obstetrics and Gynecology, Port-Royal Cochin Hospital and Necker Hospital, Assistance Publique-Hôpitaux de Paris, Descartes University, Paris, and the Department of Clinical Research Necker-Cochin, Necker-Cochin Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
出版信息
Obstet Gynecol. 2016 Oct;128(4):805-11. doi: 10.1097/AOG.0000000000001626.
OBJECTIVE
To evaluate the effectiveness and safety of misoprostol administered simultaneously with oxytocin as part of the active management of the third stage of labor.
METHODS
This multicenter, double-blind, randomized, placebo-controlled trial recruited women in the first stage of labor with expected vaginal deliveries at 36-42 weeks of gestation. Exclusion criteria were multiple pregnancies, hypersensitivity to misoprostol, and cesarean delivery. Participants received routine intravenous oxytocin and were randomly allocated to receive 400 micrograms misoprostol or placebo orally immediately after delivery of the newborn. The primary outcome was postpartum hemorrhage (500 mL or greater within 2 hours of birth). Secondary outcomes included severe postpartum hemorrhage (1,000 mL or greater) and adverse maternal events such as fever, shivering, and nausea. Two groups of 1,550 women were required to demonstrate a 33% decrease of postpartum hemorrhage according to a two-tailed α at 0.05 with 80% power. An interim analysis was planned after 50% enrollment.
RESULTS
Participant enrollment occurred from April 2010 to September 2013. Baseline characteristics were similar in the two groups. The study was discontinued after the planned interim analysis including 1,721 patients showed that misoprostol was not effective and was associated with significantly more adverse effects. The rate of postpartum hemorrhage was 8.4% (68/806) in the misoprostol and 8.3% (66/797) in the placebo group (P=.98), and rates of severe postpartum hemorrhage were 1.8% and 2.4%, respectively (P=.57). Maternal adverse events occurred significantly more frequently in the misoprostol group (for fever 30.4% in the misoprostol group compared with 6.3% in the placebo group, P<.001; for shivering 10.8% in the misoprostol group compared with 0.6% in the placebo group, P<.001).
CONCLUSION
Misoprostol administered with prophylactic routine oxytocin did not reduce the rate of postpartum hemorrhage risk and increased the rate of adverse events.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, https://clinicaltrials.gov, NCT01113229.
目的
评估米索前列醇与缩宫素同时使用作为第三产程积极管理措施的有效性和安全性。
方法
这项多中心、双盲、随机、安慰剂对照试验招募了妊娠36 - 42周预计经阴道分娩的第一产程妇女。排除标准为多胎妊娠、对米索前列醇过敏和剖宫产。参与者接受常规静脉缩宫素治疗，并在新生儿出生后立即随机分配口服400微克米索前列醇或安慰剂。主要结局是产后出血（出生后2小时内出血量达500毫升或更多）。次要结局包括严重产后出血（出血量达1000毫升或更多）以及诸如发热、寒战和恶心等产妇不良事件。根据双侧α为0.05且检验效能为80%，需要两组各1550名妇女以证明产后出血减少33%。计划在入组50%后进行中期分析。
结果
参与者入组时间为2010年4月至2013年9月。两组的基线特征相似。在纳入1721例患者的计划中期分析表明米索前列醇无效且不良反应显著更多后，该研究提前终止。米索前列醇组产后出血率为8.4%（68/806），安慰剂组为8.3%（66/797）（P = 0.98），严重产后出血率分别为1.8%和2.4%（P = 0.57）。米索前列醇组产妇不良事件发生频率显著更高（发热方面，米索前列醇组为30.4%，安慰剂组为6.3%，P < 0.001；寒战方面，米索前列醇组为10.8%，安慰剂组为0.6%，P < 0.001）。
结论
预防性使用常规缩宫素时加用米索前列醇并未降低产后出血风险，反而增加了不良事件发生率。
临床试验注册
ClinicalTrials.gov，https://clinicaltrials.gov，NCT01113229
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