Serena M Liu, Andrea Henkel, Pamela Meza, Jade M Shorter, Erica Cahill, Paul D Blumenthal, Kate A Shaw
{"title":"经宫颈球囊与渗透扩张器在程序性流产前宫颈准备中的比较：非劣效随机试验。","authors":"Serena M Liu, Andrea Henkel, Pamela Meza, Jade M Shorter, Erica Cahill, Paul D Blumenthal, Kate A Shaw","doi":"10.1016/j.contraception.2024.110550","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to compare cervical preparation with transcervical balloon to osmotic dilators for second-trimester procedural abortions.</p><p><strong>Study design: </strong>We performed an unblinded, randomized, noninferiority trial of people undergoing second-trimester procedural abortion at 18 + 0 to 23 + 6 weeks' gestation. We randomized participants to either overnight osmotic dilators (Dilapan-S) or transcervical balloon (Foley). Both groups received overnight mifepristone and preprocedural misoprostol. We powered the study on mean difference in procedure duration, a noninferiority limit of 5 minutes. We compared preprocedure cervical dilation and the need for additional dilation and, using a 100-point visual analog scale, measured physician satisfaction and ease of procedure, and participant pain and satisfaction.</p><p><strong>Results: </strong>We recruited 32 participants at a single academic center. Although procedure time (minutes) was similar (balloon: 22.6 ± 8.9 vs Dilapan-S: 22.4 ± 12.8, p = 0.96), noninferiority was not met (mean difference, 0.2 minutes; 95% CI, -7.8 to 8.2). Cervical dilation >2 cm was more likely after Dilapan-S (100% vs 62.5%, p = 0.02). Placement was well tolerated with similar time (minutes) for insertion (balloon: 4.8 ± 1.0, Dilapan-S: 5.1 ± 2.3, p = 0.64) and maximum pain (median) with insertion (balloon 39 [5-78], Dilapan-S: 39 [0-100], p = 0.92). Pain immediately postinsertion was higher for Dilapan-S (33 [0-100] vs 18 [0-50], p = 0.046) and similar for maximum pain overnight, participant satisfaction, and likelihood to recommend. Complications were minor and similar between groups (p = 0.60).</p><p><strong>Conclusion: </strong>While significantly more people with transcervical balloon required mechanical dilation, the difference in operative time was clinically negligible. The transcervical balloon was well tolerated and acceptable by participants.</p><p><strong>Implications: </strong>Clinicians experienced in mechanical dilation may consider a transcervical balloon as a lower-cost tool for second-trimester abortion cervical preparation.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov: NCT05099991.</p>","PeriodicalId":93955,"journal":{"name":"Contraception","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparing transcervical balloon with osmotic dilators for cervical preparation prior to procedural abortion: A noninferiority randomized trial.\",\"authors\":\"Serena M Liu, Andrea Henkel, Pamela Meza, Jade M Shorter, Erica Cahill, Paul D Blumenthal, Kate A Shaw\",\"doi\":\"10.1016/j.contraception.2024.110550\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>This study aimed to compare cervical preparation with transcervical balloon to osmotic dilators for second-trimester procedural abortions.</p><p><strong>Study design: </strong>We performed an unblinded, randomized, noninferiority trial of people undergoing second-trimester procedural abortion at 18 + 0 to 23 + 6 weeks' gestation. We randomized participants to either overnight osmotic dilators (Dilapan-S) or transcervical balloon (Foley). Both groups received overnight mifepristone and preprocedural misoprostol. We powered the study on mean difference in procedure duration, a noninferiority limit of 5 minutes. We compared preprocedure cervical dilation and the need for additional dilation and, using a 100-point visual analog scale, measured physician satisfaction and ease of procedure, and participant pain and satisfaction.</p><p><strong>Results: </strong>We recruited 32 participants at a single academic center. Although procedure time (minutes) was similar (balloon: 22.6 ± 8.9 vs Dilapan-S: 22.4 ± 12.8, p = 0.96), noninferiority was not met (mean difference, 0.2 minutes; 95% CI, -7.8 to 8.2). Cervical dilation >2 cm was more likely after Dilapan-S (100% vs 62.5%, p = 0.02). Placement was well tolerated with similar time (minutes) for insertion (balloon: 4.8 ± 1.0, Dilapan-S: 5.1 ± 2.3, p = 0.64) and maximum pain (median) with insertion (balloon 39 [5-78], Dilapan-S: 39 [0-100], p = 0.92). Pain immediately postinsertion was higher for Dilapan-S (33 [0-100] vs 18 [0-50], p = 0.046) and similar for maximum pain overnight, participant satisfaction, and likelihood to recommend. Complications were minor and similar between groups (p = 0.60).</p><p><strong>Conclusion: </strong>While significantly more people with transcervical balloon required mechanical dilation, the difference in operative time was clinically negligible. The transcervical balloon was well tolerated and acceptable by participants.</p><p><strong>Implications: </strong>Clinicians experienced in mechanical dilation may consider a transcervical balloon as a lower-cost tool for second-trimester abortion cervical preparation.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov: NCT05099991.</p>\",\"PeriodicalId\":93955,\"journal\":{\"name\":\"Contraception\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-07-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contraception\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1016/j.contraception.2024.110550\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contraception","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.contraception.2024.110550","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Comparing transcervical balloon with osmotic dilators for cervical preparation prior to procedural abortion: A noninferiority randomized trial.
Objectives: This study aimed to compare cervical preparation with transcervical balloon to osmotic dilators for second-trimester procedural abortions.
Study design: We performed an unblinded, randomized, noninferiority trial of people undergoing second-trimester procedural abortion at 18 + 0 to 23 + 6 weeks' gestation. We randomized participants to either overnight osmotic dilators (Dilapan-S) or transcervical balloon (Foley). Both groups received overnight mifepristone and preprocedural misoprostol. We powered the study on mean difference in procedure duration, a noninferiority limit of 5 minutes. We compared preprocedure cervical dilation and the need for additional dilation and, using a 100-point visual analog scale, measured physician satisfaction and ease of procedure, and participant pain and satisfaction.
Results: We recruited 32 participants at a single academic center. Although procedure time (minutes) was similar (balloon: 22.6 ± 8.9 vs Dilapan-S: 22.4 ± 12.8, p = 0.96), noninferiority was not met (mean difference, 0.2 minutes; 95% CI, -7.8 to 8.2). Cervical dilation >2 cm was more likely after Dilapan-S (100% vs 62.5%, p = 0.02). Placement was well tolerated with similar time (minutes) for insertion (balloon: 4.8 ± 1.0, Dilapan-S: 5.1 ± 2.3, p = 0.64) and maximum pain (median) with insertion (balloon 39 [5-78], Dilapan-S: 39 [0-100], p = 0.92). Pain immediately postinsertion was higher for Dilapan-S (33 [0-100] vs 18 [0-50], p = 0.046) and similar for maximum pain overnight, participant satisfaction, and likelihood to recommend. Complications were minor and similar between groups (p = 0.60).
Conclusion: While significantly more people with transcervical balloon required mechanical dilation, the difference in operative time was clinically negligible. The transcervical balloon was well tolerated and acceptable by participants.
Implications: Clinicians experienced in mechanical dilation may consider a transcervical balloon as a lower-cost tool for second-trimester abortion cervical preparation.
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