Department of Perinatology, Etlik Zübeyde Hanım Woman's Health Care Training and Research Hospital, Ankara, Turkey.
Department of Obstetrics and Gynecology, Ozel Bati Hospital, Diyarbakir, Turkey.
Int J Gynaecol Obstet. 2021 Dec;155(3):496-504. doi: 10.1002/ijgo.13807. Epub 2021 Jul 18.
To introduce a new handmade device, the double Foley catheter (DFC), and compare it with the Foley catheter (FC) and Cook cervical ripening balloon for its effectiveness in labor induction.
This prospective randomized controlled trial included 222 patients with unfavorable cervices. The patients were randomly allocated to the DFC, FC, and Cook cervical ripening balloon groups (n = 74 patients per group). The outcomes were evaluated using SPSS v. 23.
Bishop scores successfully increased with all three methods (P = 0.000 for all groups), and the rates of vaginal delivery within 24 and 48 h were similar (P = 0.101 and P = 0.390, respectively). The pain scores of the DFC and Cook cervical ripening balloon groups were similar, but were lower than those of the FC group (P = 0.011). The overall maternal satisfaction scores of the DFC and Cook cervical ripening balloon groups were not significantly different but were higher than those of the FC group (P = 0.014).
The maternal safety and success rate of labor induction were comparable between groups. However, the FC group had a higher pain score during catheter insertion and a lower maternal satisfaction rate. Moreover, considering the high cost of the Cook cervical ripening balloon, the DFC has an advantage, especially in low-resource countries.
介绍一种新的手工制作装置,即双 Foley 导管(DFC),并将其与 Foley 导管(FC)和 Cook 宫颈扩张球囊进行比较,以评估其在引产中的效果。
这是一项前瞻性随机对照试验,纳入了 222 例宫颈条件不佳的患者。将患者随机分为 DFC 组、FC 组和 Cook 宫颈扩张球囊组(每组 74 例患者)。使用 SPSS v. 23 评估结局。
三种方法均能成功提高 Bishop 评分(所有组 P 值均为 0.000),24 小时和 48 小时内阴道分娩率相似(P 值分别为 0.101 和 0.390)。DFC 组和 Cook 宫颈扩张球囊组的疼痛评分相似,但均低于 FC 组(P 值分别为 0.011 和 0.011)。DFC 组和 Cook 宫颈扩张球囊组的总产妇满意度评分无显著差异,但均高于 FC 组(P 值分别为 0.014 和 0.014)。
各组间引产的母婴安全性和成功率相当。然而,FC 组在导管插入时疼痛评分较高,产妇满意度较低。此外,考虑到 Cook 宫颈扩张球囊的高成本,DFC 具有优势,特别是在资源匮乏的国家。