单独使用地诺前列酮栓与米非司酮联合地诺前列酮栓用于初产妇引产的比较：一项前瞻性试点研究。
A comparison between labor induction with only Dilapan-S and a combination of mifepristone and Dilapan-S in nulliparous women: a prospective pilot study.
机构信息
National Medical Research Center for Obstetrics, Gynecology and Perinatology Named after Academician V.I. Kulakov of the Ministry of Healthcare of Russian Federation, Moscow, Russia.
Federal State Autonomous Educational Institution of Higher Education, IM Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia.
出版信息
J Matern Fetal Neonatal Med. 2021 Sep;34(17):2832-2837. doi: 10.1080/14767058.2019.1671340. Epub 2019 Oct 1.
OBJECTIVE
The aim of our study was to determine whether the combination of mifepristone and the osmotic dilator Dilapan-S improves the labor induction outcomes as compared to Dilapan-S alone.
METHODS
This prospective comparative study included 127 eligible women, of whom 58 underwent cervical ripening with Dilapan-S (12-h exposure, the control group) and 69 with Dilapan-S, with a concurrent pretreatment of 200 mg oral mifepristone (the study group), 8 h before Dilapan-S insertion.
RESULTS
The vaginal delivery rate in the control group and the study group was 60.3 and 76.8% ( = .045), respectively; the induction to delivery interval was 22.74 ± 3.01 h and 19,890 ± 2.42 h ( < .001), respectively; and the number of births within 24 h was 43.1 and 73.9% ( < .001), respectively. There was no difference in the rate of failed labor induction (6.9 versus 8.7%, = .939). The Bishop's score improved significantly after the combined treatment as compared to with Dilapan alone (3.10 ± 0.58 versus 4.03 ± 1.35, < .001). Moreover, in the study group, labor started earlier and proceeded faster with a lower additional oxytocin usage for labor induction or augmentation. There were no differences in the operative delivery rate and the perinatal outcomes. There were no adverse side effects of both mifepristone and Dilapan-S.
CONCLUSION
Our study is the first one to show that in comparison to labor induction using only osmotic dilators Dilapan-S, the combination of mifepristone and Dilapan-S is more efficient in terms of improving cervical ripening and vaginal delivery rate and reducing labor duration and frequency of oxytocin augmentation. The results revealed that this combined method is safe and has no immediate adverse effects on newborns. More studies are needed to evaluate what clinical cases are the most appropriate for the application of this combined method, considering the parity, degree of cervical ripening, and indication for labor induction.
目的
本研究旨在比较米非司酮与渗透扩张器地诺前列酮联合应用与单纯应用地诺前列酮对引产结局的影响。
方法
这是一项前瞻性比较研究，纳入了 127 名符合条件的女性，其中 58 名接受地诺前列酮（12 小时暴露，对照组）宫颈成熟，69 名接受地诺前列酮预处理，同时口服米非司酮 200mg（研究组），在插入地诺前列酮前 8 小时。
结果
对照组和研究组的阴道分娩率分别为 60.3%和 76.8%（=0.045）；引产至分娩的间隔时间分别为 22.74±3.01 小时和 19.890±2.42 小时（<0.001）；24 小时内分娩的人数分别为 43.1%和 73.9%（<0.001）。两组引产失败率无差异（6.9%比 8.7%，=0.939）。与单独使用地诺前列酮相比，联合治疗后 Bishop 评分显著提高（3.10±0.58 比 4.03±1.35，<0.001）。此外，在研究组中，米非司酮联合地诺前列酮组更早开始分娩，进展更快，用于引产或加强宫缩的催产素用量较低。两组剖宫产率和围产儿结局无差异。米非司酮和地诺前列酮均无不良反应。
结论
本研究首次表明，与仅使用渗透扩张器地诺前列酮进行引产相比，米非司酮联合地诺前列酮在改善宫颈成熟度和阴道分娩率、缩短产程和减少催产素加强宫缩的频率方面更有效。结果表明，这种联合方法是安全的，对新生儿无直接不良影响。需要更多的研究来评估哪种临床情况最适合应用这种联合方法，考虑到产妇的产次、宫颈成熟度和引产指征。
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