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Comparison of single- and double-balloon catheters for labor induction: a systematic review and meta-analysis of randomized controlled trials

Abstract

Objective

There is a paucity of head-to-head randomized trials that compare single- and double-balloon catheters, and the results of the available data in terms of time from catheter insertion to delivery and delivery mode are mixed. This meta-analysis of randomized controlled trials compares the efficacy of single- and double-balloon catheters in women undergoing labor induction.

Study design

Searches were made in MEDLINE, EMBASE, PubMed, ClinicalTrials.gov, and the Cochrane Library from inception through June 2016. Peer-reviewed randomized and quasi-randomized trials that compared single- and double-balloon catheters head-to-head for cervical ripening or labor induction were identified. Eligible study populations consisted of women with singleton pregnancies that had any indication for labor induction and were randomly assigned to undergo induction with a single- or a double-balloon catheter. The primary outcome was time from catheter insertion to delivery and delivery mode. The secondary outcomes were intrapartum fever or chorioamnionitis, woman’s satisfaction, and neonatal Apgar score.

Results

Of the 520 records identified, five randomized trials (996 women; 491 with single-balloon and 505 with double-balloon catheters) were considered eligible and included in the meta-analysis. Time from catheter insertion to delivery did not differ between the two types of catheter (p = 0.527; WMD −0.87; 95% CI: −3.55, 1.82). The incidence of cesarean delivery also did not differ (p = 0.844; RR 0.97; 95% CI: 0.69, 1.35). Delivery within 24 h, delivery mode, incidences of intrapartum fever or chorioamnionitis, and neonatal Apgar score <7 at 5 min did not differ between the two types of catheter as well. Women who were induced with the single-balloon catheter were more satisfied (p = 0.029; WMD 0.56; 95% CI: 0.06, 1.06).

Conclusion

Time from catheter insertion to delivery and delivery mode were comparable between the two types of catheter.

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References

  1. Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Munson ML. Births: final data for 2003. Natl Vital Stat Rep 2005;54:1–116.

    Google Scholar 

  2. Induction of labor. ACOG practice bulletin no. 107. American College of Obstetricians and Gynecologists. Obstet Gynecol 2009;114:386–97.

    Article  Google Scholar 

  3. Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev 2001;4:CD001233.

    Google Scholar 

  4. Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol 2006;49:642–57.

    Article  PubMed  Google Scholar 

  5. Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, et al. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol 2010;115:1239–45.

    Article  PubMed  Google Scholar 

  6. McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a transcervical foley catheter as a source of infection: a systematic review and meta-analysis. Obstet Gynecol 2015;126:539–51.

    Article  PubMed  Google Scholar 

  7. Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, et al. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol 2012;207:125.e1–7.

    Article  CAS  Google Scholar 

  8. Zafran N, Garmi G, Zuarez-Easton S, Nachum Z, Salim R. Cervical ripening with the balloon catheter and the risk of subsequent preterm birth. J Perinatol 2015;35:799–802.

    Article  CAS  PubMed  Google Scholar 

  9. Cheng YW, Shaffer BL, Bryant AS, Caughey AB. Length of the first stage of labor and associated perinatal outcomes in nulliparous women. Obstet Gynecol 2010;116:1127–35.

    Article  PubMed  Google Scholar 

  10. Spong CY, Berghella V, Wenstrom KD, Mercer BM, Saade GR. Preventing the first cesarean delivery: summary of a joint Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, and American College of Obstetricians and Gynecologists Workshop. Obstet Gynecol 2012;120:1181–93.

    PubMed  PubMed Central  Google Scholar 

  11. Justus Hofmeyr G. Induction of labour with an unfavourable cervix. Best Pract Res Clin Obstet Gynaecol 2003;17:777–94.

    Article  CAS  PubMed  Google Scholar 

  12. MacKenzie IZ, Magill P, Burns E. Randomised trial of one versus two doses of prostaglandin E2 for induction of labour: 2. Analysis of cost. Br J Obstet Gynaecol 1997;104:1068–72.

    Article  CAS  PubMed  Google Scholar 

  13. Austin K, Chambers GM, de Abreu Lourenco R, Madan A, Susic D, Henry A. Cost-effectiveness of term induction of labour using inpatient prostaglandin gel versus outpatient Foley catheter. Aust N Z J Obstet Gynaecol 2015;55:440–5.

    Article  PubMed  Google Scholar 

  14. Salim R, Zafran N, Nachum Z, Garmi G, Kraiem N, Shalev E. Single-balloon compared with double-balloon catheters for induction of labor: a randomized controlled trial. Obstet Gynecol 2011;118:79–86.

    Article  PubMed  Google Scholar 

  15. Mei-Dan E, Walfisch A, Suarez-Easton S, Hallak M. Comparison of two mechanical devices for cervical ripening: a prospective quasi- randomized trial. J Matern Fetal Neonatal Med 2012;25:723–7.

    Article  PubMed  Google Scholar 

  16. Pennell CE, Henderson JJ, O’Neill MJ, McChlery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG 2009;116:1443–52.

    Article  CAS  PubMed  Google Scholar 

  17. Rab MT, Mohammed AB, Zahran KA, Hassan MM, Eldeen AR, Ebrahim EM, et al. Transcervical Foley’s catheter versus Cook balloon for cervical ripening in stillbirth with a scarred uterus: a randomized controlled trial. J Matern Fetal Neonatal Med 2015;28:1181–5.

    Article  PubMed  Google Scholar 

  18. Hoppe KK, Schiff MA, Peterson SE, Gravett MG. 30 mL Single- versus 80 mL double-balloon catheter for pre-induction cervical ripening: a randomized controlled trial. J Matern Fetal Neonatal Med 2016;29:1919–25.

    Article  PubMed  Google Scholar 

  19. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JPA, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009;339:b2700.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001;14(357):1191–4.

    Article  Google Scholar 

  21. Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol 2014;14:135.

    Article  PubMed  PubMed Central  Google Scholar 

  22. American College of Obstetricians and Gynecologists. Induction of labor. ACOG practice bulletin no. 107. Obstet Gynecol 2009;114:386–97.

    Article  Google Scholar 

  23. Embrey MP, Mollison BG. The unfavourable cervix and induction of labour using a cervical balloon. J Obstet Gynaecol Br Commonw 1967;74:44–8.

    Article  CAS  PubMed  Google Scholar 

  24. Atad J, Bornstein J, Calderon I, Petrikovsky BM, Sorokin Y, Abramovici H. Nonpharmaceutical ripening of the unfavorable cervix and induction of labor by a novel double balloon device. Obstet Gynecol 1991;77:146–52.

    CAS  PubMed  Google Scholar 

  25. Atad J, Hallak M, Auslender R, Porat-Packer T, Zarfati D, Abramovici H. A randomized comparison of prostaglandin E2, oxytocin, and the double-balloon device in inducing labor. Obstet Gynecol 1996;87:223–7.

    Article  CAS  PubMed  Google Scholar 

  26. Shetty A, Burt R, Rice P, Templeton A. Women’s perceptions, expectations and satisfaction with induced labour--a questionnaire-based study. Eur J Obstet Gynecol Reprod Biol 2005;123:56–61.

    Article  PubMed  Google Scholar 

  27. Walker KF, Bugg GJ, Macpherson M, McCormick C, Grace N, Wildsmith C, et al. Randomized trial of labor induction in women 35 years of age or older. N Engl J Med 2016;374:813–22.

    Article  CAS  PubMed  Google Scholar 

  28. Miller NR, Cypher RL, Foglia LM, Pates JA, Nielsen PE. Elective induction of labor compared with expectant management of nulliparous women at 39 weeks of gestation: a randomized controlled trial. Obstet Gynecol 2015;126:1258–64.

    Article  PubMed  Google Scholar 

  29. Levy R, Kanengiser B, Furman B, Ben Arie A, Brown D, Hagay ZJ. A randomized trial comparing a 30-mL and an 80-mL Foley catheter balloon for preinduction cervical ripening. Am J Obstet Gynecol 2004;191:1632–6.

    Article  PubMed  Google Scholar 

  30. Kashanian M, Nazemi M, Malakzadegan A. Comparison of 30-mL and 80-mL Foley catheter balloons and oxytocin for preinduction cervical ripening. Int J Obstet Gynaecol 2009;105:174–5.

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

Mrs. Snait Ayalon, MA, clinical librarian, Emek Medical Center, Afula, Israel, for assisting in data search and extraction.

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Correspondence to Raed Salim.

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The authors declare that they have no competing financial interests.

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Salim, R., Schwartz, N., Zafran, N. et al. Comparison of single- and double-balloon catheters for labor induction: a systematic review and meta-analysis of randomized controlled trials. J Perinatol 38, 217–225 (2018). https://doi.org/10.1038/s41372-017-0005-7

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