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      Double- versus single-balloon catheters for labour induction and cervical ripening: a meta-analysis

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          Abstract

          Background

          The induction of labour is an increasingly common procedure in the obstetrics field. Various methods have been used to induce labour, among which balloon catheters play an important role. Whether the specifically designed double-balloon catheter is better than the single-balloon device in terms of efficacy, efficiency, safety and patient satisfaction remains controversial. Identifying even small differences between these two devices could be useful to guide clinical practices, to further explore their mechanisms, and to promote a better understanding of the optimal methods for inducing labour.

          Methods

          Using the population, intervention, comparison, outcomes and study designs (PICOS) principle, we searched the PubMed, EMBASE, OVID, SCI, CENTRAL, ClinicalTrial.gov, and CDSR databases to identify relevant randomised controlled trials (RCTs) from inception through February 14, 2018. The primary outcome was the caesarean delivery rate, and the secondary outcomes focused on efficacy, efficiency, safety, and patient satisfaction. The relative risks or mean differences, including their 95% confidence intervals, were calculated using fixed-effects or random-effects models. All statistical analyses were completed with RevMan version 5.3.

          Results

          From a total of 1326 articles, 7 RCTs involving 1159 women were included. There were no significant differences in primary outcomes (RR, 0.88 [0.65, 1.2]; p-value, 0.43) or secondary outcomes identified between single- and double-balloon catheters. However, heterogeneity existed for some aspects.

          Conclusion

          Both kinds of balloon catheter have similar levels of efficacy, efficiency, safety and patient satisfaction; however, the single-balloon method is considered to be more cost-effective.

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          Most cited references28

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          Measurement of feelings using visual analogue scales.

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            PELVIC SCORING FOR ELECTIVE INDUCTION.

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              Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel.

              To compare the efficacy and patient satisfaction of three methods of labour induction (double balloon catheters, single balloon catheters and prostaglandin gel) in term nulliparous women with unfavourable cervices. Randomised controlled trial. A total of 330 nulliparous women with unfavourable cervices induced at term. Three cervical ripening study arms were used: double balloon catheter (107 women); 16F Foley catheter (110 women) and PGE(2) gel (2 mg) (113 women). Caesarean section, induction to delivery interval, adverse reactions and patient satisfaction. There was no difference in caesarean delivery rates between groups (double balloon 43%, single balloon 36%, PGE(2) 37%, P = 0.567). The induction to delivery interval was longer in the double balloon group (median 24.5; 95% CI 23.7, 30.6 hours) than the single balloon (23.2; 20.8, 25.8 hours) or PGE(2) (23.8; 21.7, 26.8 hours) (P = 0.043). Uterine hyperstimulation occurred in 14% of the PGE(2) group with none occurring with mechanical cervical ripening. Cord blood gases were worse in the PGE(2) group: median arterial pH double balloon 7.26 (range 7.03-7.40); single balloon 7.26 (7.05-7.44); PGE(2) 7.25 (6.91-7.41) (P = 0.050). Cervical ripening with the single balloon catheter was associated with significantly less pain (pain score > or =4: double balloon 55%, single balloon 36%, PGE(2) 63%, P < 0.001). Labour induction in nullipara with unfavourable cervices results in high caesarean delivery rates. Although all methods in this study had similar efficacy, the single balloon catheter offers the best combination of safety and patient comfort.
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                Author and article information

                Contributors
                14802315@qq.com , qihongbocy@gmail.com
                Journal
                BMC Pregnancy Childbirth
                BMC Pregnancy Childbirth
                BMC Pregnancy and Childbirth
                BioMed Central (London )
                1471-2393
                16 October 2019
                16 October 2019
                2019
                : 19
                : 358
                Affiliations
                [1 ]GRID grid.452206.7, Department of Obstetrics and Gynecology, , The First Affiliated Hospital of Chongqing Medical University, ; No. 1 Youyi Road, Yuzhong District, Chongqing, 400016 China
                [2 ]ISNI 0000 0000 8653 0555, GRID grid.203458.8, First Clinical Institute, Chongqing Medical University, ; No. 1 Yixueyuan Road, Yuzhong District, Chongqing, 400016 China
                [3 ]ISNI 0000 0000 8653 0555, GRID grid.203458.8, School of Public Health and Management, , Chongqing Medical University, ; No. 1 Yixueyuan Road, Yuzhong District, Chongqing, 400016 China
                Article
                2491
                10.1186/s12884-019-2491-4
                6796470
                31619189
                a0ba0477-bfcf-437a-b5a3-df5896410c70
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 25 July 2018
                : 4 September 2019
                Funding
                Funded by: The National Natural Science Foundation of China
                Award ID: 81771614
                Award ID: 81771613
                Award Recipient :
                Funded by: The National Key Research and Development Program of China
                Award ID: 2016YFC1000407
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2019

                Obstetrics & Gynecology
                labour induction,cervical ripening,balloon catheter,meta-analysis
                Obstetrics & Gynecology
                labour induction, cervical ripening, balloon catheter, meta-analysis

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