MEchanical DIlatation of the Cervix-- in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery

Soe-Na Choo, Abhiram Kanneganti, Muhammad Nur Dinie Bin Abdul Aziz, Leta Loh, Carol Hargreaves, Vikneswaran Gopal, Arijit Biswas, Yiong Huak Chan, Ida Suzani Ismail, Claudia Chi, Citra Mattar, Soe-Na Choo, Abhiram Kanneganti, Muhammad Nur Dinie Bin Abdul Aziz, Leta Loh, Carol Hargreaves, Vikneswaran Gopal, Arijit Biswas, Yiong Huak Chan, Ida Suzani Ismail, Claudia Chi, Citra Mattar

Abstract

Introduction: Labour induction in women with a previous caesarean delivery currently uses vaginal prostaglandin E2 (PGE2), which carries the risks of uterine hyperstimulation and scar rupture. We aim to compare the efficacy of mechanical labour induction using a transcervically applied Foley catheter balloon (FCB) with PGE2 in affected women attempting trial of labour after caesarean (TOLAC).

Methods and analysis: This single-centre non-inferiority prospective, randomised, open, blinded-endpoint study conducted at an academic maternity unit in Singapore will recruit a total of 100 women with one previous uncomplicated caesarean section and no contraindications to vaginal delivery. Eligible consented participants with term singleton pregnancies and unfavourable cervical scores (≤5) requiring labour induction undergo stratified randomisation based on parity and are assigned either FCB (n=50) or PGE2 (n=50). Treatments are applied for up to 12 hours with serial monitoring of the mother and the fetus and serial assessment for improved cervical scores. If the cervix is still unfavourable, participants are allowed a further 12 hours' observation for cervical ripening. Active labour is initiated by amniotomy at cervical scores of ≥6. The primary outcome is the rate of change in the cervical score, and secondary outcomes include active labour within 24 hours of induction, vaginal delivery, time-to-delivery interval and uterine hyperstimulation. All analyses will be intention-to-treat. The data generated in this trial may guide a change in practice towards mechanical labour induction if this proves efficient and safer for women attempting TOLAC compared with PGE2, to improve labour management in this high-risk population.

Ethics and dissemination: Ethical approval is granted by the Domain Specific Review Board (Domain D) of the National Healthcare Group, Singapore. All adverse events will be reported within 24 hours of notification for assessment of causality. Data will be published and will be available for future meta-analyses.

Trial registration number: NCT03471858; Pre-results.

Keywords: caesarean; fetal medicine; maternal medicine; mechanical induction of labour; vaginal prostaglandin.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Intervention protocol showing recruitment, randomisation, monitoring and delivery. BS, Bishop score; CS, caesarean section; CTG, cardiotocogram; IOL, induction of labour; IV, intravenous; SC, subcutaneous; VBAC, vaginal births after caesarean section; SROM, Spontaneous Rupture of Membranes

References

    1. Betrán AP, Ye J, Moller A-B, et al. . The increasing trend in caesarean section rates: global, regional and national estimates: 1990-2014. PLoS One 2016;11:e0148343 10.1371/journal.pone.0148343
    1. Betran AP, Torloni MR, Zhang JJ, et al. . Who statement on caesarean section rates. BJOG: Int J Obstet Gy 2016;123:667–70. 10.1111/1471-0528.13526
    1. Chong C, Su LL, Biswas A. Changing trends of cesarean section births by the Robson ten group classification in a tertiary teaching hospital. Acta Obstet Gynecol Scand 2012;91:1422–7. 10.1111/j.1600-0412.2012.01529.x
    1. Moini A, Riazi K, Ebrahimi A, et al. . Caesarean section rates in teaching hospitals of Tehran: 1999-2003. East Mediterr Health J 2007;13:457–60.
    1. Amatya A, Paudel R, Poudyal A, et al. . Examining stratified cesarean section rates using Robson classification system at Tribhuvan university teaching hospital. J Nepal Health Res Counc 2013;11:255–8.
    1. ACOG Committee on Practice Bulletins -- Obstetrics ACOG practice Bulletin No. 107: induction of labor. Obstet Gynecol 2009;114:386–97. 10.1097/AOG.0b013e3181b48ef5
    1. Guise J-M, Denman MA, Emeis C, et al. . Vaginal birth after cesarean: new insights on maternal and neonatal outcomes. Obstet Gynecol 2010;115:1267–78. 10.1097/AOG.0b013e3181df925f
    1. Rossi AC, Prefumo F. Pregnancy outcomes of induced labor in women with previous cesarean section: a systematic review and meta-analysis. Arch Gynecol Obstet 2015;291:273–80. 10.1007/s00404-014-3444-9
    1. Royal_College_of_Obstetricans_and_Gynaecologists Birth after previous caesarean birth (Green-top guideline No. 45). Royal College of Obstetricians and Gynaecologists 2015.
    1. American College of Obstetricians and Gynecologists Committee on Obstetric Practice ACOG Committee opinion no. 342: induction of labor for vaginal birth after cesarean delivery. Obstet Gynecol 2006;108:465–8. 10.1097/00006250-200608000-00045
    1. Bujold E. Evaluating professional Society guidelines on vaginal birth after cesarean. Semin Perinatol 2010;34:314–7. 10.1053/j.semperi.2010.05.004
    1. The_American_College_of_Obstetricians_and_Gynecologists ACOG: practice Bulletin: vaginal birth after cesarean delivery: Obstet Gynecol, 2017: e217–33.
    1. Royal_Australian_and_New_Zealand_College_of_Obstetricians_and_Gynaecologists Birth after previous caesarean section, 2018.
    1. The_National_Institute_for_Health_and_Care_Excellence National collaborating centre for women's and children's health (UK). induction of labour. NICE clinical guidelines No. 70. London: RCOG Press, 2008.
    1. Society of Obstetricians and Gynaecologists of Canada SOGC clinical practice guidelines. guidelines for vaginal birth after previous caesarean birth. number 155 (replaces guideline number 147), February 2005. Int J Gynaecol Obstet 2005;89:319–31. 10.1016/j.ijgo.2005.03.015
    1. Lydon-Rochelle M, Holt VL, Easterling TR, et al. . Risk of uterine rupture during labor among women with a prior cesarean delivery. N Engl J Med 2001;345:3–8. 10.1056/NEJM200107053450101
    1. Eden KB, Denman MA, Emeis CL, et al. . Trial of labor and vaginal delivery rates in women with a prior cesarean. Journal of Obstetric, Gynecologic & Neonatal Nursing 2012;41:583–98. 10.1111/j.1552-6909.2012.01388.x
    1. World Health Organization Who recommendations for induction of labour. Geneva, 2011.
    1. Laughon SK, Zhang J, Troendle J, et al. . Using a simplified bishop score to predict vaginal delivery. Obstetrics & Gynecology 2011;117:805–11. 10.1097/AOG.0b013e3182114ad2
    1. Royal_College_of_Obstetricians_and_Gynaecologists Induction of labour. Evidence-based Clinical Guideline Number 2001;9.
    1. Arulkumaran S, Gibb DMF, TambyRaja RL, et al. . Failed induction of labour. Aust N Z J Obstet Gynaecol 1985;25:190–3. 10.1111/j.1479-828X.1985.tb00641.x
    1. Edwards RK, Richards DS. Preinduction cervical assessment. Clin Obstet Gynecol 2000;43:440–6. 10.1097/00003081-200009000-00004
    1. Khan NB, Ahmed I, Malik A, et al. . Factors associated with failed induction of labour in a secondary care hospital. J Pak Med Assoc 2012;62:6–10.
    1. Teixeira C, Lunet N, Rodrigues T, et al. . The bishop score as a determinant of labour induction success: a systematic review and meta-analysis. Arch Gynecol Obstet 2012;286:739–53. 10.1007/s00404-012-2341-3
    1. Bakker R, Pierce S, Myers D. The role of prostaglandins E1 and E2, dinoprostone, and misoprostol in cervical ripening and the induction of labor: a mechanistic approach. Arch Gynecol Obstet 2017;296:167–79. 10.1007/s00404-017-4418-5
    1. Riskin-Mashiah S, Wilkins I. Cervical ripening. Obstet Gynecol Clin North Am 1999;26:243–57. 10.1016/S0889-8545(05)70072-3
    1. Kirby RS. Trends in labor induction in the United States: is it true that what goes up must come down? Birth 2004;31:148–51. 10.1111/j.0730-7659.2004.00294.x
    1. Rayburn WF, Zhang J. Rising rates of labor induction: present concerns and future strategies. Obstet Gynecol 2002;100:164–7. 10.1016/s0029-7844(02)02047-1
    1. Zhang J, Yancey MK, Henderson CE. U.S. national trends in labor induction, 1989–1998. Obstet Gynecol Surv 2002;57:498–9. 10.1097/00006254-200208000-00011
    1. HaSCI C. NHS Maternity Statistics - England, 2013-14 In: Analysis Hes, 2015.
    1. Welfare AIoHa Australia’s mothers and babies 2015—in brief In: Perinatal statistics series No. 33. cat No. per 91, 2017.
    1. Martin JA, Hamilton BE, Osterman MJ, et al. . Births: final data for 2012. Natl Vital Stat Rep 2013;62:1–68.
    1. Walker KF, Bugg GJ, Macpherson M, et al. . Randomized trial of labor induction in women 35 years of age or older. N Engl J Med 2016;374:813–22. 10.1056/NEJMoa1509117
    1. Ten Eikelder MLG, Mast K, van der Velden A, et al. . Induction of labor using a Foley catheter or misoprostol: a systematic review and meta-analysis. Obstet Gynecol Surv 2016;71:620–30. 10.1097/OGX.0000000000000361
    1. Ouzounian JG, Miller DA, Hiebert CJ, et al. . Vaginal birth after cesarean section: risk of uterine rupture with labor induction. Am J Perinatol 2011;28:593–6. 10.1055/s-0031-1275386
    1. Harper LM, Cahill AG, Boslaugh S, et al. . Association of induction of labor and uterine rupture in women attempting vaginal birth after cesarean: a survival analysis. Am J Obstet Gynecol 2012;206:51.e1–51.e5. 10.1016/j.ajog.2011.09.022
    1. Ophir E, Odeh M, Hirsch Y, et al. . Uterine rupture during trial of labor: controversy of induction's methods. Obstet Gynecol Surv 2012;67:734–45. 10.1097/OGX.0b013e318273feeb
    1. Jozwiak M, Bloemenkamp KWM, Kelly AJ, et al. . Mechanical methods for induction of labour. Cochrane Database Syst Rev 2012;25 10.1002/14651858.CD001233.pub2
    1. Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol 2006;49:642–57. 10.1097/00003081-200609000-00022
    1. Jozwiak M, Bloemenkamp KW, Kelly AJ, et al. . Mechanical methods for induction of labour. Cochrane Database Syst Rev 2001;14 10.1002/14651858.CD001233.pub2
    1. ten Eikelder MLG, Oude Rengerink K, Jozwiak M, et al. . Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial. The Lancet 2016;387:1619–28. 10.1016/S0140-6736(16)00084-2
    1. Løkkegaard E, Lundstrøm M, Kjær MM, et al. . Prospective multi-centre randomised trial comparing induction of labour with a double-balloon catheter versus dinoprostone. J Obstet Gynaecol 2015;35:797–802. 10.3109/01443615.2015.1011101
    1. Connolly KA, Kohari KS, Factor SH, et al. . A randomized trial of Foley balloon induction of labor trial in Multiparas (FIAT-M). Am J Perinatol 2017;34:1108–14. 10.1055/s-0037-1603994
    1. Prager M, Eneroth-Grimfors E, Edlund M, et al. . A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG 2008;115:1443–50. 10.1111/j.1471-0528.2008.01843.x
    1. Jozwiak M, ten Eikelder M, Oude Rengerink K, et al. . Foley catheter versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and meta-analysis of literature. Am J Perinatol 2014;31:145–56. 10.1055/s-0033-1341573
    1. Jozwiak M, Rengerink KO, Benthem M, et al. . Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial. The Lancet 2011;378:2095–103. 10.1016/S0140-6736(11)61484-0
    1. Vaknin Z, Kurzweil Y, Sherman D. Foley catheter balloon vs locally applied prostaglandins for cervical ripening and labor induction: a systematic review and metaanalysis. Am J Obstet Gynecol 2010;203:418–29. 10.1016/j.ajog.2010.04.038
    1. Ziyauddin F, Hakim S, Beriwal S. The transcervical foley catheter versus the vaginal prostaglandin e2 gel in the induction of labour in a previous one caesarean section - a clinical study. J Clin Diagn Res 2013;7:140–3. 10.7860/JCDR/2012/5003.2689
    1. Ben-Aroya Z, Hallak M, Segal D, et al. . Ripening of the uterine cervix in a post-cesarean parturient: prostaglandin E2 versus Foley catheter. J Matern Fetal Neonatal Med 2002;12:42–5. 10.1080/jmf.12.1.42.45
    1. Cheuk QKY, Lo TK, Lee CP, et al. . Double balloon catheter for induction of labour in Chinese women with previous caesarean section: one-year experience and literature review. Hong Kong Med J 2015;21:243–50. 10.12809/hkmj144404
    1. Barda G, Ganer Herman H, Sagiv R, et al. . Foley catheter versus intravaginal prostaglandins E2 for cervical ripening in women at term with an unfavorable cervix: a randomized controlled trial. J Matern Fetal Neonatal Med 2018;31:2777–81. 10.1080/14767058.2017.1355906
    1. Ferradas ER, Alvarado IL, Gabilondo MA, et al. . Double balloon device compared to oxytocin for induction of labour after previous caesarean section. Open J Obstet Gynecol 2013;03:212–6. 10.4236/ojog.2013.31A039
    1. Jozwiak M, van de Lest HA, Burger NB, et al. . Cervical ripening with Foley catheter for induction of labor after cesarean section: a cohort study. Acta Obstet Gynecol Scand 2014;93:296–301. 10.1111/aogs.12320
    1. Lundgren I, Smith V, Nilsson C, et al. . Clinician-centred interventions to increase vaginal birth after caesarean section (VBAC): a systematic review. BMC Pregnancy Childbirth 2015;15:16 10.1186/s12884-015-0441-3
    1. West HM, Jozwiak M, Dodd JM, et al. . Methods of term labour induction for women with a previous caesarean section. Cochrane Database Syst Rev 2017;4 10.1002/14651858.CD009792.pub3
    1. Rath W, Kehl S. The renaissance of transcervical balloon catheters for cervical ripening and labour induction. Geburtshilfe Frauenheilkd 2015;75:1130–9. 10.1055/s-0035-1558094
    1. Huisman CMA, Jozwiak M, de Leeuw JW, et al. . Cervical ripening in the Netherlands: a survey. Obstet Gynecol Int 2013;2013 10.1155/2013/745159
    1. Hansson L, Hedner T, Dahlöf B. Prospective randomized open blinded end-point (probe) study. A novel design for intervention trials. prospective randomized open blinded end-point. Blood Press 1992;1:113–9.
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Schulz KF, Altman DG, Moher D, et al. . Consort 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340 10.1136/bmj.c332
    1. The_National_Institute_for_Health_and_Care_Excellence Caesarean Section National Institute for Health and Care Excellence, 2013.
    1. Hofmeyr GJ. Obstructed labor: using better technologies to reduce mortality. Int J Gynaecol Obstet 2004;85 Suppl 1:S62–72. 10.1016/j.ijgo.2004.01.011
    1. Tejani N, Verma UL. Correlation of Apgar scores and umbilical artery acid-base status to mortality and morbidity in the low birth weight neonate. Obstet Gynecol 1989;73:597–600.
    1. Mei-Dan E, Walfisch A, Suarez-Easton S, et al. . Comparison of two mechanical devices for cervical ripening: a prospective quasi-randomized trial. J Matern Fetal Neonatal Med 2012;25:723–7. 10.3109/14767058.2011.591459
    1. Kehl S, Weiss C, Dammer U, et al. . Double-balloon catheter and sequential oral misoprostol versus oral misoprostol alone for induction of labour at term: a retrospective cohort study. Eur J Obstet Gynecol Reprod Biol 2016;204:78–82. 10.1016/j.ejogrb.2016.07.507
    1. Locatelli A, Regalia AL, Ghidini A, et al. . Risks of induction of labour in women with a uterine scar from previous low transverse caesarean section. BJOG 2004;111:1394–9. 10.1111/j.1471-0528.2004.00287.x
    1. Baranov A, Gratacós E, Vikhareva O, et al. . Validation of the prediction model for success of vaginal birth after cesarean delivery at the university hospital in Barcelona. J Matern Fetal Neonatal Med 2017;30:2998–3003. 10.1080/14767058.2016.1271407
    1. Bellows P, Shah U, Hawley L, et al. . Evaluation of outcomes associated with trial of labor after cesarean delivery after a change in clinical practice guidelines in an academic Hospital. J Matern Fetal Neonatal Med 2017;30:2092–6. 10.1080/14767058.2016.1237498
    1. Maykin M, Mularz A, Lee L, et al. . Validation of a prediction model for vaginal birth after cesarean delivery reveals unexpected success in a diverse American population. AJP Rep 2017;07:e31–8. 10.1055/s-0037-1599129
    1. Tsai H-T, Wu C-H. Vaginal birth after cesarean section-The world trend and local experience in Taiwan. Taiwan J Obstet Gynecol 2017;56:41–5. 10.1016/j.tjog.2016.03.007
    1. Ganesan G. Branch CQ, Deliveries in Singapore. Singapore: Ministry of Health, Singapore, 2004.
    1. Smith JA. Balloon dilators for labor induction: a historical review. J Med Ethics Hist Med 2013;6.
    1. Chen W, Xue J, Peprah MK, et al. . A systematic review and network meta-analysis comparing the use of Foley catheters, misoprostol, and dinoprostone for cervical ripening in the induction of labour. BJOG: Int J Obstet Gy 2016;123:346–54. 10.1111/1471-0528.13456
    1. 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. 10.1097/AOG.0000000000001002
    1. Heinemann J, Gillen G, Sanchez-Ramos L, et al. . Do mechanical methods of cervical ripening increase infectious morbidity? A systematic review. Am J Obstet Gynecol 2008;199:177–88. 10.1016/j.ajog.2008.05.005
    1. Tan TL, GY N, SEL L, et al. . Cervical ripening balloon as an alternative for induction of labour: a randomized controlled trial. BJMP 2015;8.
    1. Lajusticia H, Martínez-Domínguez SJ, Pérez-Roncero GR, et al. . Single versus double-balloon catheters for the induction of labor of singleton pregnancies: a meta-analysis of randomized and quasi-randomized controlled trials. Arch Gynecol Obstet 2018;297:1089–100. 10.1007/s00404-018-4713-9
    1. Yang F, Huang S, Long Y, et al. . Double-balloon versus single-balloon catheter for cervical ripening and labor induction: a systematic review and meta-analysis. J Obstet Gynaecol Res 2018;44:27–34. 10.1111/jog.13551
    1. Sandberg EM, Schepers EM, Sitter RLvan, et al. . Foley catheter for induction of labour filled with 30 mL or 60 mL: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol 2017;211:150–5. 10.1016/j.ejogrb.2017.02.019
    1. Gu N, Ru T, Wang Z, et al. . Foley catheter for induction of labor at term: an open-label, randomized controlled trial. PLoS One 2015;10:e0136856 10.1371/journal.pone.0136856
    1. Cabrera IB, Quiñones JN, Durie D, et al. . Use of intracervical balloons and chorioamnionitis in term premature rupture of membranes. The Journal of Maternal-Fetal & Neonatal Medicine 2016;29:967–71. 10.3109/14767058.2015.1027191
    1. Kruit H, Tihtonen K, Raudaskoski T, et al. . Foley catheter or oral misoprostol for induction of labor in women with term premature rupture of membranes: a randomized multicenter trial. Am J Perinatol 2016;33:866–72. 10.1055/s-0036-1580608
    1. Amorosa JMH, Stone J, Factor SH, et al. . A randomized trial of Foley Bulb for Labor Induction in Premature Rupture of Membranes in Nulliparas (FLIP). Am J Obstet Gynecol 2017;217:360.e1–360.e7. 10.1016/j.ajog.2017.04.038

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