Misoprostol for Labour Induction after Previous Caesarean Section – Forever a “No Go”?

 

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Abstract

Misoprostol in oral or vaginal form is an established method of labour induction worldwide. Its use after previous caesarean section is associated with a high rate of uterine rupture; according to international guidelines it is therefore contraindicated in this setting. However the evidence base for this recommendation comprises case reports, one randomised trial that was discontinued prematurely, and numerous low quality retrospective data analyses published between 1997 and 2004. New insights into e.g. resorption kinetics, dosage and application intervals, dose dependant uterine hyperstimulation rates, as well as increasing clinical experience with misoprostol have lead to a critical reappraisal of these “historical” studies. Accordingly the evidence supporting a ban on vaginal and particularly oral misoprostol for labour induction in the context of a scarred uterus is currently insufficient for a convincing guideline recommendation. In view of the clear advantages of misoprostol over prostaglandin E₂ (cheaper, more effective) a retrospective review of registry data should be conducted to determine the incidence of uterine rupture following misoprostol and the circumstances in which it occurs. A prospective, randomised trial could then be conducted on the basis of these findings (e.g. oral misoprostol vs. vaginal prostaglandin E₂); known risk factors for uterine rupture including the type of uterine scar would need to be taken into account when selecting patients for vaginal delivery. Until new data from well-designed studies are available, misoprostol will continue to be contraindicated in clinical guidelines for use in labour induction after previous caesarean section.

Zusammenfassung

Die orale oder vaginale Gabe von Misoprostol ist weltweit eine etablierte Methode zur Geburtseinleitung. Allerdings sollte Misoprostol aufgrund des hohen Risikos für eine Uterusruptur nach internationalen Leitlinienempfehlungen nicht bei Schwangeren mit vorangegangener Sectio caesarea angewendet werden. Grundlage dieser Leitlinienempfehlungen sind Fallberichte, eine randomisierte, vorzeitig beendete Studie sowie retrospektive Datenanalysen mit niedriger Qualität, die zwischen 1997–2004 publiziert wurden. Vor dem Hintergrund neuer Erkenntnisse (Resorptionskinetik, Dosierungen und Applikationsintervalle, dosisabhängige Rate uteriner Überstimulierungen) und wachsender klinischer Erfahrungen im Umgang mit Misoprostol wurden daher diese „historischen“ Studien einer kritischen Analyse unterzogen. Danach ist die Evidenz, vaginales und vor allem orales Misoprostol zur Geburtseinleitung nach vorangegangener Sectio zu verbieten, unzureichend, um daraus überzeugende, aktuelle Leitlinienempfehlungen ableiten zu können. Im Hinblick auf die evidenten Vorteile von Misoprostol (effektiver, kostengünstiger) im Vergleich zu zugelassenen, konventionellen Prostaglandin-E₂-Präparaten ist zu empfehlen, in einem retrospektiven Datenregister die Häufigkeit und Umstände von Uterusrupturen nach Misoprostol zu evaluieren. Auf der Grundlage dieses Registers könnte dann eine prospektive, randomisierte Studie (z. B. orales Misoprostol versus vaginales Prostaglandin E₂) initiiert werden, welche die Selektion für eine vaginale Geburt infrage kommender Schwangerer und die bekannten Risikofaktoren für eine Uterusruptur einschließlich der uterinen Schnittführung bei der vorangegangenen Sectio zu berücksichtigen hat. Bevor allerdings keine neuen Ergebnisse aus gut konzipierten Studien vorliegen, bleibt Misoprostol zur Geburtseinleitung nach vorangegangener Sectio entsprechend aktuellen Leitlinien kontraindiziert.

• References

• 1 Huisman CM, Jozwiak M, de Leeuw JW et al. Cervical ripening in the Netherlands: a survey. Obstet Gynecol Int 2013; 2013: 745159
  PubMedGoogle Scholar
• 2 AQUA-Institut. Geburtshilfliche Qualitätsindikatoren – Bundesauswertung nach Erfassungsjahr 2013. Göttingen: 2014: 16/1
  Google Scholar
• 3 Voigt F, Goecke TW, Najjari L et al. Off-label use of misoprostol for labor induction in Germany: a national survey. Eur J Obstet Gynecol Reprod Biol 2015; 187: 85-89
  CrossrefPubMedGoogle Scholar
• 4 Krause E, Malorgio S, Kuhn A et al. Off-label use of misoprostol for labor induction: a nation-wide survey in Switzerland. Eur J Obstet Gynecol Reprod Biol 2011; 159: 324-328
  CrossrefPubMedGoogle Scholar
• 5 Weeks A, Alfirevic Z. Oral misoprostol administration for labour induction. Clin Obstet Gynecol 2006; 49: 658-671
  CrossrefPubMedGoogle Scholar
• 6 Weeks AD, Fiala C, Safar P. Misoprostol and the debate over off-label drug use. BJOG 2005; 112: 269-272
  CrossrefPubMedGoogle Scholar
• 7 Alfirevic Z, Aflaifel N, Weeks A. Oral misoprostol for induction of labour. Cochrane Database Syst Rev 2014; (6) CD001338
  PubMedGoogle Scholar
• 8 Tang J, Kopp W, Dragoman M et al. WHO recommendations for misoprostol use for obstetric and gynaecologic indications. Int J Gynecol Obstet 2013; 121: 186-189
  CrossrefPubMedGoogle Scholar
• 9 Hofmeyr GI, Gülmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev 2010; (2) CD00941 (update 2013)
  PubMedGoogle Scholar
• 10 ACOG Committee on Practice Bulletins – Obstetrics. ACOG Practice Bulletin No. 107: Induction of labour. Obstet Gynecol 2009; 114 (2 Pt 1) 386-397
  CrossrefPubMedGoogle Scholar
• 11 WHO recommendations for induction of labour.. Online: http://​whqlibdoc.​who.​int/​hq/​2011/​WHO_​RHR_​11.​10_eng.pdf last access: 30.04.2015
  PubMedGoogle Scholar
• 12 FIGO Misoprostol recommendations for induction of labour 2012.. Online: http://www.figo-org2012 last access: 30.04.2015
  PubMedGoogle Scholar
• 13 SOGC Clinical Practice Guideline No. 296: Induction of labour. JOGC 2013; 35: 840-857
  PubMedGoogle Scholar
• 14 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: 1394-1399
  CrossrefPubMedGoogle Scholar
• 15 Martin JA, Hamilton BP, Sutton PD et al. Births: final data for 2007. Natl Vital Stat Rep 2010; 58: 1-85
  PubMedGoogle Scholar
• 16 Landon MB, Hauth JC, Levano KJ et al. Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery. N Engl J Med 2004; 351: 2581-2589
  CrossrefPubMedGoogle Scholar
• 17 Chauhan SP, Martin JN, Henrichs CE et al. Maternal and perinatal complications with uterine rupture in 142,075 patients who attempted vaginal birth after cesarean delivery: A review of the literature. Am J Obstet Gynecol 2003; 189: 408-417
  CrossrefPubMedGoogle Scholar
• 18 Al-Zirqui I, Stray-Pedersen B, Forsen L et al. Uterine rupture after previous caesarean section. BJOG 2010; 117: 809-820
  CrossrefPubMedGoogle Scholar
• 19 ACOG Committee on Obstetric Practice. Induction of labour for vaginal birth after cesarean delivery. Obstet Gynecol 2002; 99: 679-686
  CrossrefPubMedGoogle Scholar
• 20 Uphoff R. Misoprostol zur Geburtseinleitung: Haftungsrechtliche Konsequenzen. Frauenarzt 2014; 55: 734-740
  PubMedGoogle Scholar
• 21 Wing DA, Lovett K, Paul RH. Disruption of prior uterine incision following misoprostol for labor induction in women with previous cesarean delivery. Obstet Gynecol 1998; 91: 828-830
  CrossrefPubMedGoogle Scholar
• 22 Miller DA, Paul RH. Vaginal birth after cesarean: A 10-year experience. Obstet Gynecol 1994; 84: 255-258
  PubMedGoogle Scholar
• 23 Chuck FJ, Huffaker BJ. Labor induction with intravaginal misoprostol versus intracervical prostaglandin E2 gel (Prepidil gel): randomized comparison. Am J Obstet Gynecol 1995; 173: 1137-1142
  CrossrefPubMedGoogle Scholar
• 24 Carlan SJ, Bouldin S, OʼBrien WF. Extemporaneous preparation of misoprostol gel for cervical ripening: a randomized trial. Obstet Gynecol 1997; 90: 911-915
  CrossrefPubMedGoogle Scholar
• 25 Perry jr. KG, Larmon JE, May WL et al. Cervical ripening: a randomized comparison between intravaginal misoprostol and an intracervical balloon catheter combined with intravaginal dinoprostone. Am J Obstet Gynecol 1998; 178: 1333-1340
  CrossrefPubMedGoogle Scholar
• 26 Vengalil JR, Guinn DA, Olabi NF et al. A randomized trial of misoprostol and extraamniotic saline infusion for cervical ripening and labor induction. Obstet Gynecol 1998; 91: 774-779
  CrossrefPubMedGoogle Scholar
• 27 Blanchette HA, Nayak S, Erasmus S. Comparison of the safety and efficacy of intravaginal misoprostol (prostaglandin E1) with those of dinoprostone (prostaglandin E2) for cervical ripening and induction of labor in a community hospital. Am J Obstet Gynecol 1999; 180: 1551-1559
  CrossrefPubMedGoogle Scholar
• 28 Plaut MM, Schwartz ML, Lubarsky SL. Uterine rupture associated with the use of misoprostol in the gravid patient with a previous cesarean section. Am J Obstet Gynecol 1999; 180: 1535-1542
  CrossrefPubMedGoogle Scholar
• 29 Cunha M, Bulgalno A, Biquie C et al. Induction of labor by vaginal misoprostol in patients with previous cesarean delivery. Acta Obstet Gynecol Scand 1999; 78: 633-634
  PubMedGoogle Scholar
• 30 Bennett KA, Elmore L, Fleischman S et al. Prostaglandin induction in women with a prior caesarean delivery increased induction time and risk of uterine rupture. Am J Obstet Gynecol 2000; 182: S130
  PubMedGoogle Scholar
• 31 Ophir E, Odeh M, Hirsch Y et al. Uterine rupture during trial of labor: Controversy of inductionʼs methods. Obstet Gynecol Surv 2012; 67: 734-745
  CrossrefPubMedGoogle Scholar
• 32 Sanchez-Ramos L, Francisco L, Kaunitz AM. Cervical ripening and labor induction after previous cesarean delivery. Clin Obstet Gynecol 2000; 43: 513-523
  CrossrefPubMedGoogle Scholar
• 33 Hill DA, Chez RA, Quinlan J et al. Uterine rupture and dehiscence associated with intravaginal misoprostol cervical ripening. J Reprod Med 2000; 45: 823-826
  PubMedGoogle Scholar
• 34 Choy-Hee L, Raynor BD. Misoprostol induction of labor among women with a history of cesarean delivery. Am J Obstet Gynecol 2001; 184: 1115-1117
  CrossrefPubMedGoogle Scholar
• 35 Nwachuku V, Sison A, Quathic C et al. Safety of misoprostol as a cervical ripening agent in vaginal birth after cesarean section. Prim Care Update Obstet/Gyn 2001; 8: 244-247
  PubMedGoogle Scholar
• 36 Aslan H, Unlu E, Agar M et al. Uterine rupture associated with misoprostol labor induction in women with previous cesarean delivery. Eur J Obstet Gynecol Reprod Biol 2004; 113: 45-48
  CrossrefPubMedGoogle Scholar
• 37 Lin C, Raynor BD. Risk of uterine rupture in labor induction of patients with prior cesarean section: an inner city hospital experience. Am J Obstet Gynecol 2004; 190: 1476-1478
  CrossrefPubMedGoogle Scholar
• 38 Sciscione AC, Nguyen L, Manley JS et al. Uterine rupture during preinduction cervical ripening with misoprostol in patient with a previous caesarean delivery. Aust N Z J Obstet Gynaecol 1998; 38: 96-97
  PubMedGoogle Scholar
• 39 Bennett BB. Uterine rupture during induction of labour at term in intravaginal misoprostol. Obstet Gynecol 1997; 89: 832-833
  CrossrefPubMedGoogle Scholar
• 40 Gherman RB. Trial of labor after cesarean delivery: a pilot study of oral misoprostol for preinduction cervical ripening. Obstet Gynecol 2001; 97 (Suppl. 01) S68
  PubMedGoogle Scholar
• 41 Pocock SJ. When to stop a clinical trial. BMJ 1992; 305: 235-240
  CrossrefPubMedGoogle Scholar
• 42 Lydon-Rochelle M, Holt VL, Easterling TR et al. Uterine rupture during labor among women with a prior cesarean delivery. N Engl J Med 2001; 345: 3-8
  CrossrefPubMedGoogle Scholar
• 43 Flamm DL. Vaginal birth after cesarean and the New England Journal of Medicine: a strange controversy. Birth 2001; 28: 276-279
  CrossrefPubMedGoogle Scholar
• 44 Vellekoop J, Roell-Schorer EA, von Roosmalen J. Uterine scar rupture after previous cesarean section and induction of labor with prostaglandins. Acta Obstet Gynecol Scand 2006; 85: 132-134
  CrossrefPubMedGoogle Scholar
• 45 Schmitz T, Pourulat A-G, Moutafaff C et al. Cervical ripening with low-dose prostaglandins in planned vaginal birth after cesarean. PLoS One 2013; 8: e80903
  CrossrefPubMedGoogle Scholar
• 46 Cahill AG, Stamilio DM, Odibo AO et al. Does a maximum dose of oxytocin affect risk for uterine rupture in candidates for vaginal birth after cesarean delivery?. Am J Obstet Gynecol 2007; 197: 495.e1-495.e5
  CrossrefPubMedGoogle Scholar
• 47 Carlan SJ, Bouldin S, Blust D et al. Safety and efficacy on misoprostol orally and vaginally: a randomized trial. Obstet Gynecol 2001; 98: 107-112
  CrossrefPubMedGoogle Scholar
• 48 How HY, Leaseburge L, Khoury JC et al. A comparison of various routes and dosages of misoprostol for cervical ripening and the induction of labor. Am J Obstet Gynecol 2001; 185: 911-915
  CrossrefPubMedGoogle Scholar
• 49 Ziegler D, Buletti C, Monstier de B et al. The first uterine pass effect. Ann N Y Acad Sci 1997; 828: 291-299
  CrossrefPubMedGoogle Scholar
• 50 Buhimschi CS, Buhimschi JA, Patel S et al. Rupture of the uterine scar during term labour! Contractility or biochemistry?. BJOG 2005; 112: 38-42
  PubMedGoogle Scholar
• 51 Grobman WA, Lai Y, Landon MB et al. Can a prediction model for vaginal birth after cesarean also predict the probability of morbidity related to a trial of labor?. Am J Obstet Gynecol 2009; 200: 56.e1-56.e6
  CrossrefPubMedGoogle Scholar
• 52 Schoorel ENC, van Kuijk SMJ, Melman S et al. Vaginal birth after a caesarean section: the development of a Western European population-based prediction model for deliveries at term. BJOG 2014; 121: 194-201
  CrossrefPubMedGoogle Scholar
• 53 Schoorel ENC, Melman S, van Kuijk SMJ et al. Predicting successful intended vaginal delivery after previous caesarean section: external validation of two predictive models in a Dutch nationwide registration-based cohort with a high intended vaginal delivery rate. BJOG 2014; 121: 840-847
  CrossrefPubMedGoogle Scholar

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