University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences; Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, United States.
University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences; Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, United States.
Contraception. 2021 Feb;103(2):116-120. doi: 10.1016/j.contraception.2020.10.009. Epub 2020 Oct 17.
To evaluate the efficacy of intramuscular methylergonovine maleate as prophylaxis against excessive bleeding when given after dilation and evacuation (D&E) at 20-24 weeks.
We performed a randomized, double-blinded, placebo-controlled trial in patients without excessive bleeding requiring intervention after D&E completion. We administered study treatment within one minute of the end of the procedure. We primarily compared outcomes using a composite of indicators of excessive post-procedure blood loss (post-procedure measured blood loss exceeding 125 mL, uterine massage or compression for at least two minutes, administration of additional uterotonic medication, intrauterine balloon tamponade, uterine re-aspiration, blood transfusion, uterine artery embolization, hospital admission for bleeding, or major surgery). Secondary outcomes included individual indicator occurrences, satisfaction, and side effects.
From March 3, 2015 to March 31, 2017, we randomized 284 participants (n = 140 methylergonovine, n = 144 placebo), five before we registered the trial with clinicaltrials.gov. Baseline characteristics were similar between groups. The composite outcome occurred in 78 (56%) methylergonovine and 75 (52%) placebo participants (p = 0.5). Methylergonovine recipients required more intrauterine balloon use (n = 20 [14%]) versus placebo (n = 10 [7%]), p = 0.04. We also observed a non-significant trend towards more uterotonic administration (n = 56 [40%] versus n = 43 [30%], p = 0.07) and hospital admissions for bleeding (n = 4 [3%] versus n = 0, p = 0.06) in the methylergonovine group compared to placebo.
We observed no improvement in the composite outcome for excessive bleeding with prophylactic post-procedure methylergonovine. In addition, individual excessive bleeding outcomes occurred more frequently in the methylergonovine group, potentially indicating harm with its prophylactic use after D&E.
When administered prophylactically immediately after dilation and evacuation abortion at 20-24 weeks, methylergonovine increases uterine bleeding. Given the lack of data for effectiveness as a prophylactic agent and our findings indicating harm, we do not recommend its use for post-operative prophylaxis.
评估马来酸甲麦角新碱肌内注射作为预防 20-24 周扩张和排空（D&E）后过度出血的疗效。
我们对 D&E 完成后无需干预即无过度出血的患者进行了一项随机、双盲、安慰剂对照试验。我们在手术结束后一分钟内给予研究治疗。我们主要通过过度术后出血的综合指标来比较结果（术后测量出血量超过 125 毫升、子宫按摩或按压至少两分钟、给予额外的子宫收缩药物、宫内球囊填塞、子宫再抽吸、输血、子宫动脉栓塞、因出血住院或大手术）。次要结果包括个别指标的发生、满意度和副作用。
从 2015 年 3 月 3 日至 2017 年 3 月 31 日，我们随机分配了 284 名参与者（n=140 名甲麦角新碱，n=144 名安慰剂），其中 5 名在我们向 clinicaltrials.gov 注册试验之前。两组间基线特征相似。复合结局发生在 78 名（56%）甲麦角新碱和 75 名（52%）安慰剂参与者中（p=0.5）。甲麦角新碱组需要更多的宫内球囊使用（n=20 [14%]）与安慰剂组（n=10 [7%]），p=0.04。我们还观察到一种非显著的趋势，即甲麦角新碱组比安慰剂组需要更多的子宫收缩药物（n=56 [40%] vs n=43 [30%]，p=0.07）和因出血而住院（n=4 [3%] vs n=0，p=0.06）。
我们观察到预防性术后甲麦角新碱不能改善过度出血的复合结局。此外，在甲麦角新碱组中，个别过度出血结局更常见，这可能表明其在 D&E 后预防性使用存在危害。
在 20-24 周扩张和排空流产后立即预防性给予甲麦角新碱会增加子宫出血。鉴于缺乏作为预防性药物的有效性数据，并且我们的研究结果表明存在危害，因此我们不建议将其用于术后预防。
