Department of Obstetrics and Gynecology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China.
BMC Pregnancy Childbirth. 2022 Oct 2;22(1):739. doi: 10.1186/s12884-022-05035-w.
This study aims to evaluate the efficacy and safety of the modified application of COOK Cervical Ripening Balloon (CCRB) for induction of labor (IOL) at term in primipara.
A total of 227 singleton full-term pregnancies with indications of IOL were enrolled and randomly divided into the control and study groups in our hospital from January 2021 to December 2021. In the control group, a conventional method was used. Both the uterine and vaginal balloons were filled to 80 mL and removed after 12 h. In the study group, a modified method was used. The uterine and vaginal balloons were filled to 120 mL and 40 mL respectively. Light traction was given to help CCRB to be discharged after 12 h placement. Oxytocin was administered in both groups after CCRB was discharged before labor starting. The improved Bishop scores, duration of labor, and spontaneous delivery rate were evaluated in the two groups.
The improved Bishop scores in the study group were 3.06 ± 0.97 at 12 h placement of CCRB and 4.37 ± 0.87 when CCRB was discharged, which were significantly higher compared to the control group (2.52 ± 0.79, p < 0.05). Duration of the first stage of labor and the full labor in the study group were significantly shorter than those in the control group ((6.17 ± 2.85) h vs. (7.27 ± 2.90) h, p = 0.010; (7.07 ± 3.18) h vs. (8.09 ± 3.11) h, p = 0.028). No difference in spontaneous delivery rate between the two groups was observed. But the delivery rate within 24 h between the two groups was significantly different (79.79% vs. 55.91%, p < 0.05). For the cases with initial Bishop scores ≤ 3, the improved score was significantly increased, the first stage of labor and the full labor were significantly shorter in the study group than those in the control group (p < 0.05). Those results were not observed in cases with initial Bishop scores of 4-6.
The modified application of CCRB could benefit cervical ripening, shorten the duration of labor, especially for cases with poor cervical maturity, and improve the delivery rate within 24 h.
Retrospectively registered: ChiCTR2200058270. Registered 04/04/2022.
本研究旨在评估改良 COOK 宫颈扩张球囊（CCRB）在初产妇足月引产中的疗效和安全性。
2021 年 1 月至 12 月，我院收治的 227 例有引产指征的单胎足月妊娠患者，随机分为对照组和观察组。对照组采用常规方法，子宫和阴道球囊分别充液至 80mL 和 40mL，12h 后取出。观察组采用改良方法，子宫和阴道球囊分别充液至 120mL 和 40mL，放置 12h 后轻拉协助 CCRB 排出，球囊排出后两组均给予缩宫素引产。比较两组改良 Bishop 评分、产程时间及自然分娩率。
观察组 CCRB 放置 12h 时的改良 Bishop 评分为 3.06±0.97，球囊排出时为 4.37±0.87，均显著高于对照组的 2.52±0.79（均 P<0.05）。观察组第一产程和总产程时间均显著短于对照组[（6.17±2.85）h 比（7.27±2.90）h，P=0.010；（7.07±3.18）h 比（8.09±3.11）h，P=0.028]。两组自然分娩率差异无统计学意义，但观察组 24h 内分娩率显著高于对照组[79.79%比 55.91%，P<0.05]。对于初始 Bishop 评分≤3 的患者，观察组改良评分显著增加，第一产程和总产程时间显著短于对照组（均 P<0.05），而初始 Bishop 评分 4-6 的患者则无此差异。
改良 CCRB 应用可促进宫颈成熟，缩短产程时间，尤其对宫颈成熟度较差的患者，可提高 24h 内分娩率。
回顾性注册，ChiCTR2200058270，于 2022 年 4 月 4 日注册。
