Ferring Pharmaceuticals, Copenhagen, Denmark.
Tipping Consulting LLC, Green Lane, PA, USA.
BJOG. 2017 Apr;124(5):796-803. doi: 10.1111/1471-0528.14147. Epub 2016 Jun 16.
To assess adverse event (AE) resolution, delivery mode and neonatal outcomes after misoprostol or dinoprostone vaginal insert (MVI or DVI) retrieval due to AE during induction of labour (IOL).
Randomised, double-blind trial, EXPEDITE.
Thirty five obstetric departments, USA.
Consisted of 1358 pregnant women with modified Bishop score ≤4 eligible for pharmacological IOL.
Post hoc analysis.
AEs prompting insert retrieval, times to AE resolution, delivery, delivery mode and neonatal intensive care unit (NICU) admissions.
77/678 (11.4%) and 27/680 (4.0%) women had MVI and DVI retrieved due to AE, respectively (P < 0.001). The most common AEs prompting retrieval were uterine tachysystole with fetal heart rate (FHR) involvement and category II/III FHR pattern. Time to AE resolution varied for both treatments depending on the type of AE. For uterine tachysystole with FHR involvement, median resolution times were 1 hour 34.5 minutes (n = 36) and 8.5 minutes (n = 8) for MVI and DVI, respectively. Caesarean delivery occurred in a high proportion of women with insert retrieved due to AE (MVI: 44/77 (57.1%); DVI: 19/27 (70.4%)); the majority of caesareans were performed at least several hours after insert retrieval. Median times from retrieval to any delivery were not increased for women with insert retrieved due to AE. NICU admissions were 8/77 (10.4%) and 1/27 (3.7%) for MVI and DVI, respectively (P = 0.440).
AEs leading to insert retrieval were primarily uterine tachysystole with FHR involvement and category II/III FHR patterns. Insert retrieval due to an AE did not prolong time to delivery for either prostaglandin insert.
Induction with prostaglandin vaginal inserts: outcomes following retrieval due to intrapartum adverse event.
评估因诱导分娩(IOL)期间不良反应(AE)而使用米索前列醇或地诺前列酮阴道栓剂(MVI 或 DVI)后,AE 解决情况、分娩方式和新生儿结局。
随机、双盲试验,EXPEDITE。
美国 35 个产科部门。
纳入 1358 名改良 Bishop 评分≤4 的适合药物性 IOL 的孕妇。
事后分析。
因 AE 而取出栓剂的 AE 发生率、AE 解决时间、分娩、分娩方式和新生儿重症监护病房(NICU)入院率。
77/678(11.4%)和 27/680(4.0%)名妇女因 AE 而分别取出 MVI 和 DVI(P<0.001)。最常见的因 AE 而取出栓剂的原因是伴有胎儿心率(FHR)受累的子宫收缩过频和 II/III 类 FHR 模式。两种治疗方法的 AE 解决时间取决于 AE 的类型而有所不同。对于伴有 FHR 受累的子宫收缩过频,MVI 和 DVI 的中位解决时间分别为 1 小时 34.5 分钟(n=36)和 8.5 分钟(n=8)。因 AE 而取出栓剂的妇女中有相当高比例行剖宫产(MVI:44/77(57.1%);DVI:19/27(70.4%));大多数剖宫产在取出栓剂后数小时进行。对于因 AE 而取出栓剂的妇女,从取出栓剂到任何分娩的中位时间并未延长。MVI 和 DVI 的新生儿重症监护病房(NICU)入院率分别为 8/77(10.4%)和 1/27(3.7%)(P=0.440)。
导致栓剂取出的 AE 主要是伴有 FHR 受累的子宫收缩过频和 II/III 类 FHR 模式。对于任何一种前列腺素栓剂,因 AE 而取出栓剂并不延长分娩时间。
使用前列腺素阴道栓剂引产:因产时不良事件取出后的结局。