Outpatient Cervical Ripening: A Systematic Review and Meta-analysis

Marian McDonagh, Andrea C Skelly, Ellen Tilden, Erika D Brodt, Tracy Dana, Erica Hart, Shelby N Kantner, Rongwei Fu, Amy C Hermesch, Marian McDonagh, Andrea C Skelly, Ellen Tilden, Erika D Brodt, Tracy Dana, Erica Hart, Shelby N Kantner, Rongwei Fu, Amy C Hermesch

Abstract

Objective: To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening in the outpatient setting alone.

Data sources: Searches for articles in English included MEDLINE, EMBASE, CINAHL, Cochrane Library, ClinicalTrials.gov, and reference lists (up to August 2020).

Methods of study selection: Using predefined criteria and DistillerSR software, 10,853 citations were dual-reviewed for randomized controlled trials (RCTs) and cohort studies of outpatient cervical ripening using prostaglandins and mechanical methods in pregnant women at or beyond 37 weeks of gestation.

Tabulation, integration, and results: Using prespecified criteria, study data abstraction and risk of bias assessment were conducted by two reviewers, random-effects meta-analyses were conducted and strength of evidence was assessed. We included 30 RCTs and 10 cohort studies (N=9,618) most generalizable to women aged 25-30 years with low-risk pregnancies. All findings were low or insufficient strength of evidence and not statistically significant. Incidence of cesarean delivery was not different for any comparison of inpatient and outpatient settings, or comparisons of different methods in the outpatient setting (most evidence available for single-balloon catheters and dinoprostone). Harms were inconsistently reported or inadequately defined. Differences were not found for neonatal infection (eg, sepsis) with outpatient compared with inpatient dinoprostone, birth trauma (eg, cephalohematoma) with outpatient compared with inpatient single-balloon catheter, shoulder dystocia with outpatient dinoprostone compared with placebo, maternal infection (eg, chorioamnionitis) with outpatient compared with inpatient single-balloon catheters or outpatient prostaglandins compared with placebo, and postpartum hemorrhage with outpatient catheter compared with inpatient dinoprostone. Evidence on misoprostol, hygroscopic dilators, and other outcomes (eg, perinatal mortality and time to vaginal birth) was insufficient.

Conclusion: In women with low-risk pregnancies, outpatient cervical ripening with dinoprostone or single-balloon catheters did not increase cesarean deliveries. Although there were no clear differences in harms when comparing outpatient with inpatient cervical ripening, the certainty of evidence is low or insufficient to draw definitive conclusions.

Systematic review registration: PROSPERO, CRD42020167406.

Conflict of interest statement

Financial Disclosure Amy Hermesch disclosed that money was paid to her from GenBioPro as a consultant. The other authors did not report any potential conflicts of interest.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

Fig. 1.. Meta-analysis of cesarean delivery with…
Fig. 1.. Meta-analysis of cesarean delivery with prostaglandins for cervical ripening: outpatient (OP) vs inpatient (IP). *Risk ratio estimate calculated from author's adjusted odds ratio comparing inpatient with outpatient. RCT, randomized controlled trial.
McDonagh. Outpatient Cervical Ripening. Obstet Gynecol 2021.
Fig. 2.. Meta-analysis of cesarean delivery with…
Fig. 2.. Meta-analysis of cesarean delivery with catheters for cervical ripening: outpatient (OP) vs inpatient (IP). *Risk ratio estimate calculated from author's adjusted odds ratio comparing inpatient with outpatient. RCT, randomized controlled trial.
McDonagh. Outpatient Cervical Ripening. Obstet Gynecol 2021.
Fig. 3.. Meta-analysis of cesarean delivery with…
Fig. 3.. Meta-analysis of cesarean delivery with prostaglandins vs placebo for cervical ripening in the outpatient setting.
McDonagh. Outpatient Cervical Ripening. Obstet Gynecol 2021.

References

    1. Martin JA, Hamilton BE, Osterman MJK, Driscoll AK, Drake P. Births: final data for 2017. National vital statistics reports: from the centers for disease control and prevention, national center for health statistics, Natl Vital Stat Syst 2018;67:1–50
    1. Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, et al. . Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med 2018;379:513–23. doi: 10.1056/NEJMoa1800566
    1. Induction of labor. ACOG Practice Bulletin No. 107. American College of Obstetricians and Gynecologists. Obstet Gynecol 2009;114:386–97. doi: 10.1097/AOG.0b013e3181b48ef5
    1. Management of late-term and postterm pregnancies. Practice Bulletin No. 146. American College of Obstetricians Gynecologists. Obstet Gynecol 2014;124:390–6. doi: 10.1097/01.AOG.0000452744.06088.48
    1. Bernardes TP, Broekhuijsen K, Koopmans CM, Boers KE, van Wyk L, Tajik P, et al. . Caesarean section rates and adverse neonatal outcomes after induction of labour versus expectant management in women with an unripe cervix: a secondary analysis of the HYPITAT and DIGITAT trials. BJOG 2016;123:1501–8. doi: 10.1111/1471-0528.14028
    1. Bartha JL, Romero-Carmona R, Martinez-Del-Fresno P, Comino-Delgado R. Bishop score and transvaginal ultrasound for preinduction cervical assessment: a randomized clinical trial. Ultrasound Obstet Gynecol 2005;25:155–9. doi: 10.1002/uog.1813
    1. Carlson NS, Neal JL, Tilden EL, Smith DC, Breman RB, Lowe NK, et al. . Influence of midwifery presence in United States centers on labor care and outcomes of low-risk parous women: a Consortium on Safe Labor study. Birth 2019;46:487–99. doi: 10.1111/birt.12405
    1. Neal JL, Carlson NS, Phillippi JC, Tilden EL, Smith DC, Breman RB, et al. . Midwifery presence in United States medical centers and labor care and birth outcomes among low-risk nulliparous women: a Consortium on Safe Labor study. Birth 2019;46:475–48. doi: 10.1111/birt.12407
    1. Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG 2018;125:1086–95. doi: 10.1111/1471-0528.15047
    1. Smith LK. Outpatient induction of labour with prostaglandins: safety, effectiveness and women's views. Br J Midwifery 2017;25:774–82. doi: 10.12968/bjom.2017.25.12.774
    1. Vogel JP, Osoti AO, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Pharmacological and mechanical interventions for labour induction in outpatient settings. The Cochrane Database of Systematic Reviews 2017, Issue 9. Art. No.: CD007701. doi: 10.1002/14651858.CD007701.pub3
    1. McDonagh M, Skelly AC, Hermesch A, Tilden E, Brodt ED, Dana T, et al. . Cervical ripening in the outpatient setting. Comparative Effectiveness Review No. 238. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 290-2015-00009-I for the Agency for Healthcare Research and Quality and the Patient-Centered Outcomes Research Institute.) AHRQ Publication No. 21-EHC011. PCORI Publication No. 2020-SR-03. Agency for Healthcare Research and Quality; 2021. doi: 10.23970/AHRQEPCCER238. Posted final reports are located on the Effective Health Care Program search page.
    1. Agency for Healthcare Research and Quality. Cervical ripening in the outpatient setting: research protocol. Accessed February 19, 2021.
    1. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. . Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 2015;4:1. doi: 10.1186/2046-4053-4-1
    1. Awartani KA, Turnell RW, Olatunbosun OA. A prospective study of induction of labor with prostaglandin vaginal gel: ambulatory versus in-patient administration. Clin Exp Obstet Gynecol 1999;26:162–5.
    1. Beckmann M, Gibbons K, Flenady V, Kumar S. Induction of labour using prostaglandin E2 as an inpatient versus balloon catheter as an outpatient: a multicentre randomised controlled trial. BJOG 2020;127:571–9. doi: 10.1111/1471-0528.16030
    1. Biem SR, Turnell RW, Olatunbosun O, Tauh M, Biem HJ. A randomized controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction. J Obstet Gynaecol Can 2003;25:23–31. doi: 10.1016/s1701-2163(16)31079-9
    1. Buttino LT, Jr, Garite TJ. Intracervical prostaglandin in postdate pregnancy. A randomized trial. J Reprod Med 1990;35:155–8.
    1. Chang DW, Velazquez MD, Colyer M, Klaus P, Mallipeddi SK, Rayburn WF. Vaginal misoprostol for cervical ripening at term: comparison of outpatient vs. inpatient administration. J Reprod Med 2005;50:735–9.
    1. Cundiff GW, Simpson ML, Koenig N, Lee T. Observational study of neonatal safety for outpatient labour induction priming with dinoprostone vaginal insert. J Obstet Gynaecol Can 2017;39:354–60. doi: 10.1016/j.jogc.2017.01.003
    1. Doany W, McCarty J. Outpatient management of the uncomplicated postdate pregnancy with intravaginal prostaglandin E2 gel and membrane stripping. J Matern Fetal Med 1997;6:71–8. doi: 10.1002/(SICI)1520-6661(199703/04)6:2<71::AID-MFM2>;2-M.
    1. Farmer KC, Schwartz WJ, III, Rayburn WF, Turnbull G. A cost-minimization analysis of intracervical prostaglandin E2 for cervical ripening in an outpatient versus inpatient setting. Clin Ther 1996;18:747–56. doi: 10.1016/s0149-2918(96)80224-4
    1. Gaffaney CA, Saul LL, Rumney PJ, Morrison EH, Thomas S, Nageotte MP, et al. . Outpatient oral misoprostol for prolonged pregnancies: a pilot investigation. Am J Perinatol 2009;26:673–7. doi: 10.1055/s-0029-1220790
    1. Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, et al. . Outpatient foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth 2013;13:25. doi: 10.1186/1471-2393-13-25
    1. Herabutya Y, Prasertsawat PO. A comparison of oral and intracervical prostaglandin E2 for ripening of the unfavourable cervix prior to induction of labour. J Med Assoc Thai 1988;71:269–73.
    1. Howard K, Gerard K, Adelson P, Bryce R, Wilkinson C, Turnbull D. Women's preferences for inpatient and outpatient priming for labour induction: a discrete choice experiment. BMC Health Serv Res 2014;14:330. doi: 10.1186/1472-6963-14-330
    1. Incerpi MH, Fassett MJ, Kjos SL, Tran SH, Wing DA. Vaginally administered misoprostol for outpatient cervical ripening in pregnancies complicated by diabetes mellitus. Am J Obstet Gynecol 2001;185:916–9. doi: 10.1067/mob.2001.117306
    1. Kipikasa JH, Adair CD, Williamson J, Breen JM, Medford LK, Sanchez-Ramos L. Use of misoprostol on an outpatient basis for postdate pregnancy. Int J Gynaecol Obstet 2005;88:108–11. doi: 10.1016/j.ijgo.2004.10.006
    1. Kruit H, Heikinheimo O, Ulander VM, Aitokallio-Tallberg A, Nupponen I, Paavonen J, et al. . Foley catheter induction of labor as an outpatient procedure. J Perinatol 2016;36:618–22. doi: 10.1038/jp.2016.62
    1. Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, et al. . Outpatient foley catheter for induction of labor in parous women: a randomized controlled trial. Obstet Gynecol 2018;132:94–101. doi: 10.1097/AOG.0000000000002678
    1. Larmon JE, Magann EF, Dickerson GA, Morrison JC. Outpatient cervical ripening with prostaglandin E2 and estradiol. J Matern Fetal Neonatal Med 2002;11:113–7. doi: 10.1080/jmf.11.2.113.117
    1. Lien JM, Morgan MA, Garite TJ, Kennedy KA, Sassoon DA, Freeman RK. Antepartum cervical ripening: applying prostaglandin E2 gel in conjunction with scheduled nonstress tests in postdate pregnancies. Am J Obstet Gynecol 1998;179:453–8. doi: 10.1016/s0002-9378(98)70378-3
    1. Magann EF, Chauhan SP, McNamara MF, Bass JD, Estes CM, Morrison JC. Membrane sweeping versus dinoprostone vaginal insert in the management of pregnancies beyond 41 weeks with an unfavorable cervix. J Perinatol 1999;19:88–91. doi: 10.1038/sj.jp.7200133
    1. Magann EF, Chauhan SP, Nevils BG, McNamara MF, Kinsella MJ, Morrison JC. Management of pregnancies beyond forty-one weeks' gestation with an unfavorable cervix. Am J Obstet Gynecol 1998;178:1279–87. doi: 10.1016/s0002-9378(98)70334-5
    1. McGee TM, Gidaszewski B, Khajehei M, Tse T, Gibbs E. Foley catheter silicone versus latex for term outpatient induction of labour: a randomised trial. Aust N Z J Obstet Gynaecol 2019;59:235–42. doi: 10.1111/ajo.12828
    1. McKenna DS, Costa SW, Samuels P. Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol 1999;94:11–4. doi: 10.1016/s0029-7844(99)00244-6
    1. McKenna DS, Duke JM. Effectiveness and infectious morbidity of outpatient cervical ripening with a Foley catheter. J Reprod Med 2004;49:28–32.
    1. McKenna DS, Ester JB, Proffitt M, Waddell KR. Misoprostol outpatient cervical ripening without subsequent induction of labor: a randomized trial. Obstet Gynecol 2004b;104:579–84. doi: 10.1097/01.AOG.0000136479.72777.56
    1. Meyer M, Pflum J, Howard D. Outpatient misoprostol compared with dinoprostone gel for preinduction cervical ripening: a randomized controlled trial. Obstet Gynecol 2005;105:466–72. doi: 10.1097/01.AOG.0000152341.31873.d9
    1. Oboro VO, Tabowei TO. Outpatient misoprostol cervical ripening without subsequent induction of labor to prevent post-term pregnancy. Acta Obstet Gynecol Scand 2005;84:628–31. doi: 10.1111/j.0001-6349.2005.00655.x
    1. Ohel G, Rahav D, Rothbart H, Ruach M. Randomised trial of outpatient induction of labor with vaginal PGE2 at 40-41 weeks of gestation versus expectant management. Arch Gynecol Obstet 1996;258:109–12. doi: 10.1007/s004040050110
    1. Policiano C, Pimenta M, Martins D, Clode N. Outpatient versus inpatient cervix priming with foley catheter: a randomized trial. Eur J Obstet Gynecol Reprod Biol 2017;210:1–6. doi: 10.1016/j.ejogrb.2016.11.026
    1. PonMalar J, Benjamin SJ, Abraham A, Rathore S, Jeyaseelan V, Mathews JE. Randomized double-blind placebo controlled study of preinduction cervical priming with 25 micro g of misoprostol in the outpatient setting to prevent formal induction of labour. Arch Gynecol Obstet 2017;295:33–8. doi: 10.1007/s00404-016-4173-z
    1. Rayburn WF, Gittens LN, Lucas MJ, Gall SA, Martin ME. Weekly administration of prostaglandin E2 gel compared with expectant management in women with previous cesareans. Prepidil gel study group. Obstet Gynecol 1999;94:250–4. doi: 10.1016/s0029-7844(99)00300-2
    1. Salvador SC, Lynn Simpson M, Cundiff GW. Dinoprostone vaginal insert for labour induction: a comparison of outpatient and inpatient settings. J Obstet Gynaecol Can 2009;31:1028–34. doi: 10.1016/S1701-2163(16)34347-X
    1. Sawai SK, O'Brien WF, Mastrogiannis DS, Krammer J, Mastry MG, Porter GW. Patient-administered outpatient intravaginal prostaglandin E2 suppositories in post-date pregnancies: a double-blind, randomized, placebo-controlled study. Obstet Gynecol 1994;84:807–10.
    1. Sawai SK, Williams MC, O'Brien WF, Angel JL, Mastrogiannis DS, Johnson L. Sequential outpatient application of intravaginal prostaglandin E2 gel in the management of postdates pregnancies. Obstet Gynecol 1991;78:19–23.
    1. Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol 2001;98:751–6. doi: 10.1016/s0029-7844(01)01579-4
    1. Smith CV, Miller A, Livezey GT. Double-blind comparison of 2.5 and 5.0 mg of prostaglandin E2 gel for preinduction cervical ripening. J Reprod Med 1996;41:745–8.
    1. Stitely ML, Browning J, Fowler M, Gendron RT, Gherman RB. Outpatient cervical ripening with intravaginal misoprostol. Obstet Gynecol 2000;96:684–8. doi: 10.1016/s0029-7844(00)01034-6
    1. Stock SJ, Taylor R, Mairs R, Azaghdani A, Hor K, Smith I, et al. . Home cervical ripening with dinoprostone gel in nulliparous women with singleton pregnancies. Obstet Gynecol 2014;124:354–60. doi: 10.1097/AOG.0000000000000394
    1. Turnbull D, Adelson P, Oster C, Bryce R, Fereday J, Wilkinson C. Psychosocial outcomes of a randomized controlled trial of outpatient cervical priming for induction of labor. Birth 2013;40:75–80. doi: 10.1111/birt.12035
    1. Turnbull D, Adelson P, Oster C, Coffey J, Coomblas J, Bryce R, et al. . The impact of outpatient priming for induction of labour on midwives' work demand, work autonomy and satisfaction. Women Birth 2013;26:207–12. doi: 10.1016/j.wombi.2013.03.001
    1. Upadhyaya NB, Childs KD, Neiger R, Caudle MR. Ambulatory cervical ripening in term pregnancy. J Reprod Med 1999;44:363–6.
    1. Wilkinson C, Adelson P, Turnbull D. A comparison of inpatient with outpatient balloon catheter cervical ripening: a pilot randomized controlled trial. BMC Pregnancy Childbirth 2015;15:126. doi: 10.1186/s12884-015-0550-z
    1. Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E2 (OPRA study). BJOG 2015;122:94–104. doi: 10.1111/1471-0528.12846
    1. Methods guide for effectiveness and comparative effectiveness reviews. AHRQ Publication No. 10(14)-EHC063-EF. Agency for Healthcare Research and Quality; 2014
    1. Viswanathan M, Patnode CD, Berkman ND, Bass EB, Chang S, Hartling L, et al. . Assessing the risk of bias in systematic reviews of health care interventions. Methods guide for effectiveness and comparative effectiveness reviews. Agency for Healthcare Research and Quality; 2017.
    1. Furlan AD, Malmivaara A, Chou R, Maher CG, Deyo RA, Schoene M, et al. . 2015 updated method guideline for systematic reviews in the Cochrane Back and Neck Group. Spine 2015;40:1660–73.
    1. Berkman ND, Lohr KN, Ansari MT, Balk EM, Kane R, McDonagh M, et al. . Grading the strength of a body of evidence when assessing health care interventions: an EPC update. J Clin Epidemiol 2015;68:1312–24. doi: 10.1016/j.jclinepi.2014.11.023
    1. Ausbeck EB, Jauk VC, Xue Y, Files P, Kuper SG, Subramaniam A, et al. . Outpatient foley catheter for induction of labor in nulliparous women: a randomized controlled trial. Obstet Gynecol 2020;136:597–606. doi: 10.1097/aog.0000000000004041

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