Vincienne Marie, Anselem Olivia, Cordier Anne Gaelle, Le Ray Camille, Tsatsaris Vassilis, Benachi Alexandra, Goffinet François
Maternité Port-Royal, Groupe Hospitalier Cochin-Broca-Hôtel-Dieu, Université Paris Descartes, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
Fetal Diagn Ther. 2018;43(1):61-67. doi: 10.1159/000458410. Epub 2017 Mar 29.
In France, terminations of pregnancy (TOP) for medical reasons beyond the second trimester use mifepristone and misoprostol. We sought to determine the effectiveness of Dilapan-S®, an osmotic cervical dilator, in shortening the induction-to-delivery interval (IDI).
This retrospective study of TOP in 2010-2012 compared the results from 2 hospitals with different TOP protocols starting at 16 weeks' gestation, one (164 women) with and one (106) without Dilapan-S®. The principal endpoint was the IDI. Results were analyzed according to 2 definitions of induction onset: definition 1, first dose of misoprostol in both centers, or definition 2, dilator placement if used, and otherwise first dose of misoprostol.
With definition 1, the IDI was shorter with dilators (5 h 48 min vs. 10 h 18 min, p < 0.001); the rates of uterine evacuation within 12 and 24 h were higher (94.5 and 100 vs. 68.9 and 91.5%, p < 0.001), and the time between first misoprostol dose and amniotomy was shorter (0 h 47 min vs. 4 h 30 min, p < 0.001). Under definition 2, the IDI was longer with dilators (18 h 24 min vs. 10 h 18 min, p < 0.001), but the rate of evacuation within 24 h did not differ significantly.
Dilapan-S® acts on cervical ripening and dilatation, thereby allowing early amniotomy. Assessing potential side effects and women's satisfaction requires prospective trials.
在法国,孕中期之后因医学原因终止妊娠(TOP)使用米非司酮和米索前列醇。我们试图确定渗透性宫颈扩张剂Dilapan-S®在缩短引产至分娩间隔时间(IDI)方面的有效性。
这项对2010 - 2012年TOP情况的回顾性研究比较了两家医院的结果,这两家医院从妊娠16周开始采用不同的TOP方案,一家医院(164名女性)使用Dilapan-S®,另一家(106名女性)不使用。主要终点是IDI。根据引产开始的两种定义分析结果:定义1,两个中心均为米索前列醇的首剂;定义2,若使用扩张剂则为扩张剂放置时间,否则为米索前列醇首剂。
按照定义1,使用扩张剂时IDI更短(5小时48分钟对10小时18分钟,p < 0.001);12小时和24小时内子宫排空率更高(94.5%和100%对68.9%和91.5%,p < 0.001),且米索前列醇首剂至羊膜穿刺术的时间更短(0小时47分钟对4小时30分钟,p < 0.001)。按照定义2,使用扩张剂时IDI更长(18小时24分钟对10小时18分钟,p < 0.001),但24小时内的排空率无显著差异。
Dilapan-S®作用于宫颈成熟和扩张,从而允许早期进行羊膜穿刺术。评估潜在副作用和女性满意度需要进行前瞻性试验。