Seo Densearn, Kaur Rashvinder, Ponganam Meghna Prasannan, Sam Kah Wai, Hill Maclean, Davies-Tuck Miranda, Warty Ritesh Rikain, Smith Vinayak, Tan Thiam Chye, Fox Deborah, Palmer Kirsten R
Department of Obstetrics and Gynaecology, Monash University, Faculty of Medicine, Nursing and Health Sciences, Monash Medical Centre, 246 Clayton Rd, Clayton, Victoria 3168 Australia (Seo, Davies-Tuck, Warty, Smith, and Palmer); School of Clinical Sciences, Monash University, Faculty of Medicine, Nursing and Health Sciences, 27 Rainforest Walk, Clayton, Victoria, 3168 Australia (Seo); Gravida Health Pty. Ltd., Wheelers Hill, Victoria, 3150, Australia (Seo, Kaur, Warty, Smith).
Gravida Health Pty. Ltd., Wheelers Hill, Victoria, 3150, Australia (Seo, Kaur, Warty, Smith).
Am J Obstet Gynecol MFM. 2024 Dec;6(12):101519. doi: 10.1016/j.ajogmf.2024.101519. Epub 2024 Oct 5.
Induction of labor is commonly undertaken when ongoing pregnancy poses a risk to either the mother or fetus. Often cervical preparation is required with mechanical methods increasingly popular due to their improved safety. This study evaluates the efficacy, safety, and acceptability of digital versus speculum-based balloon insertion for cervical preparation, aiming to identify gaps and inform future research.
PubMed, Ovid MEDLINE, EMBASE, and Scopus were searched from database inception until 30 June 2023.
Included studies were randomized controlled trials comparing digital versus speculum-based insertion of catheter-related balloons for labor induction in individuals with viable singleton pregnancies, in both inpatient and outpatient settings, written in English. Exclusions included studies not using cervical balloons, comparisons to nonballoon methods, nonhuman studies, and nonprimary literature like guidelines, reviews, commentaries, and opinion pieces.
Title and abstract screening were performed by 4 authors. Full-text articles were assessed against inclusion criteria. Selection was agreed upon by consensus among 3 authors, with a fourth consulted for disputes. The risk of bias was assessed using the Cochrane Risk of Bias Tool 2.0 for randomized trials. A meta-analysis was also performed.
Out of 3397 studies, 4 met the inclusion criteria, all being randomized controlled trials with some concerns in at least one domain but no high risk of bias. Two studies found digital insertion significantly less painful than speculum-based insertion (P<.001), while one reported no difference (P=.72). Maternal satisfaction was comparable, with one study favoring digital insertion (P=.011). Meta-analysis findings for other outcome measures suggest no difference between speculum or digital insertion. However, due to substantial heterogeneity, findings for procedural time, time from induction to delivery, and epidural rate should be cautiously interpreted.
Digital insertion for cervical preparation appears associated with reduced pain and higher patient acceptability compared to speculum-based insertion. Additionally, efficacy and safety were comparable, indicating it is a preferable option for clinical use. There was no difference in other procedural, obstetric, or neonatal outcomes, however, more rigorous research employing standardized outcome measures is needed to facilitate a clinically meaningful interpretation.
当继续妊娠对母亲或胎儿构成风险时，通常会进行引产。由于机械方法安全性更高，其越来越受欢迎，常常需要进行宫颈准备。本研究评估了数字式与基于窥器的球囊置入用于宫颈准备的有效性、安全性和可接受性，旨在找出差距并为未来研究提供参考。
检索了PubMed、Ovid MEDLINE、EMBASE和Scopus数据库，检索时间从数据库建立至2023年6月30日。
纳入的研究为随机对照试验，比较数字式与基于窥器的导管相关球囊置入在单胎存活妊娠个体引产中的应用，包括住院和门诊环境，且研究为英文撰写。排除标准包括未使用宫颈球囊的研究、与非球囊方法的比较、非人类研究以及指南、综述、评论和观点文章等非原始文献。
由4位作者进行标题和摘要筛选。根据纳入标准对全文进行评估。3位作者通过共识达成选择意见，如有争议则咨询第四位作者。使用Cochrane偏倚风险工具2.0对随机试验的偏倚风险进行评估。还进行了荟萃分析。
在3397项研究中，4项符合纳入标准，均为随机对照试验，至少在一个领域存在一些问题，但无高偏倚风险。两项研究发现数字式置入比基于窥器的置入疼痛明显减轻（P<0.001），而一项研究报告无差异（P = 0.72）。产妇满意度相当，一项研究更倾向于数字式置入（P = 0.011）。其他结局指标的荟萃分析结果表明，窥器置入或数字式置入之间无差异。然而，由于存在大量异质性，对操作时间、引产至分娩时间和硬膜外麻醉率的结果应谨慎解读。
与基于窥器的置入相比，数字式置入宫颈准备似乎疼痛减轻且患者可接受性更高。此外，有效性和安全性相当，表明它是临床使用的更优选择。在其他操作、产科或新生儿结局方面无差异，然而，需要采用标准化结局指标进行更严格的研究，以促进具有临床意义的解读。
