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Journal of Perinatal Medicine

Official Journal of the World Association of Perinatal Medicine

Editor-in-Chief: Dudenhausen, MD, FRCOG, Joachim W.

Ed. by Bancalari, Eduardo / Chappelle, Joseph / Chervenak, Frank A. / D'Addario , Vincenzo / Genc, Mehmet R. / Greenough, Anne / Grunebaum, Amos / Konje, Justin C. / Kurjak M.D., Asim / Romero, Roberto / Zalud, MD PhD, Ivica


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1619-3997
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Volume 47, Issue 7

Issues

Standard and adjusted criteria for the use of the misoprostol vaginal insert for labor induction: a comparative cohort study

Aleke Brandstetter
  • Department of Obstetrics and Gynecology, Asklepios Clinic Barmbek, Hamburg, Germany
  • Department of Obstetrics, Universitätsmedizin Charité, Berlin, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Moritz Döbert
  • Department of Obstetrics and Gynecology, Asklepios Clinic Barmbek, Hamburg, Germany
  • Department of Obstetrics, Universitätsmedizin Charité, Berlin, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Peter Schwaerzler / Timm Fabian Döbert
  • Asklepios Pro-Research, Hamburg, Germany
  • Department of Biological Sciences, University of Alberta, Edmonton, Alberta, Canada
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Hendrik Hasselbeck / Wolfgang Henrich
  • Corresponding author
  • Department of Obstetrics, Universitätsmedizin Charité, Berlin, Germany
  • Department of Obstetrics and Gynecology, Charité University Hospital Berlin, Charitéplatz 1, 10117 Berlin, Germany
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2019-08-02 | DOI: https://doi.org/10.1515/jpm-2019-0153

Abstract

Objective

To compare the efficacy of misoprostol vaginal insert (MVI) for labor induction using standard and adjusted criteria.

Methods

A single-center, comparative cohort study using a consecutive series of pregnant women ≥37/0 weeks undergoing labor induction with either standard criteria for MVI (administration for up to 24 h; MVI-24) or with adjusted criteria (MVI administration for a maximum of 10 h; MVI-10) conducted at a tertiary academic center in Germany. The primary outcomes were the time from start of induction to any delivery and cesarean delivery rate.

Results

A total of 138 women were included in the study, 69 in each group. The mean time from MVI administration to any delivery showed no significant difference between the MVI-24 and MVI-10 groups (954 vs. 969 min, respectively; P = 0.679). The cesarean delivery rate was proportionally lower for the MVI-10 group [39.1% (27/69) vs. 24.6% (17/69); P = 0.10].

Conclusion

The time from induction to delivery with MVI was similar when using standard criteria of up to 24 h of exposure vs. adjusted criteria of up to 10 h of exposure. Although the threshold for statistical significance for cesarean section was not attained, there is nonetheless a considerable difference between the MVI-24 and MVI-10 groups.

This article offers supplementary material which is provided at the end of the article.

Keywords: induction of labor; Misodel®; misoprostol; misoprostol vaginal insert; uterine tachysystole

References

  • 1.

    World Health Organization. WHO recommendations for induction of labor. 2011. Available from URL: http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/9789241501156/en/. Accessed April 16, 2019.

  • 2.

    Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: final data for 2015. Natl Vital Stat Rep 2017;66:1.Google Scholar

  • 3.

    Walker S, van Rijn B, Macklon N, Howe D. PLD.31 The rising rate of labour induction: what is causing the trend? Arch Dis Child Fetal Neonatal Ed 2014;99(Suppl 1):A115.Google Scholar

  • 4.

    Ekéus C, Lindgren H. Induced labor in Sweden, 1999–2012: a population-based cohort study. Birth 2016;43:125–33.CrossrefWeb of SciencePubMedGoogle Scholar

  • 5.

    SOGC. Induction of labour. J Obstet Gynaecol Can 2013;35:S1–18.Google Scholar

  • 6.

    Hedegaard M, Lidegaard Ø, Skovlund CW, Mørch LS, Hedegaard M. Reduction in stillbirths at term after new birth induction paradigm: results of a national intervention. Br Med J Open 2014;4:e005785.Google Scholar

  • 7.

    Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Kirmeyer S, Mathews TJ, et al. Births: final data for 2009. Natl Vital Stat Rep 2011;60:1–70.Google Scholar

  • 8.

    Voigt F, Goecke TW, Najjari L, Pecks U, Maass N, Rath W. Off-label use of misoprostol for labor induction in Germany: a national survey. Eur J Obstet Gynecol Reprod Biol 2014; doi:.CrossrefWeb of ScienceGoogle Scholar

  • 9.

    Martin JA, Hamilton BE, Osterman MJ, Curtin SC, Matthews TJ. Births: final data for 2013. Natl Vital Stat Rep 2015;64:1–68.PubMedGoogle Scholar

  • 10.

    Villamor E, Cnattingius S. Interpregnancy weight change and risk of adverse pregnancy outcomes: a population-based study. Lancet 2006;368:1164–70.CrossrefPubMedGoogle Scholar

  • 11.

    Cubal A, Carvalho J, Ferreira MJ, Rodrigues G, Carmo OD. Value of Bishop score and ultrasound cervical length measurement in the prediction of cesarean delivery. J Obstet Gynaecol Res 2013;39:1391–6.CrossrefPubMedWeb of ScienceGoogle Scholar

  • 12.

    Stephenson ML, Hawkins JS, Powers BL, Wing DA. Misoprostol vaginal insert for induction of labor: a delivery system with accurate dosing and rapid discontinuation. Women’s Health 2014;10:29–36.Google Scholar

  • 13.

    Schneider PH, Schneider KTM. Die Geburtshilfe. 2. Aufl. Heidelberg, Germany: Springer; 2003.Google Scholar

  • 14.

    Hofmeyr GJ, Gulmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev 2010;10:CD000941.Web of ScienceGoogle Scholar

  • 15.

    Alfirevic Z, Aflaifel N, Weeks A. Oral misoprostol for induction of labour. Cochrane Database Syst Rev 2014;6:CD001338.Web of ScienceGoogle Scholar

  • 16.

    Watkinson G, Hopkins A, Akbar FA. The therapeutic efficacy of misoprostol in peptic ulcer disease. Postgrad Med J 1988;64(Suppl 1):60–77.PubMedGoogle Scholar

  • 17.

    Ewert K, Powers B, Robertson S, Alfirevic Z. Controlled-release misoprostol vaginal insert in parous women for labor induction: a randomized controlled trial. Obstet Gynecol 2006;108:1130–7.CrossrefPubMedGoogle Scholar

  • 18.

    Ferring Misodel Product Monograph. 2014. Available from URL: https://ferring-geburtshilfe.de/wp-content/uploads/2017/01/E01-Misodel-Monograph170214PR.pdf. Accessed July 23, 2019.

  • 19.

    Wing DA, Brown R, Plante LA, Miller H, Rugarn O, Powers BL. Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. Obstet Gynecol 2013;122(2 Pt 1):201–9.CrossrefWeb of SciencePubMedGoogle Scholar

  • 20.

    Rugarn O, Tipping D, Powers B, Wing DA. Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event. Br J Obstect Gynecol 2017;124:796–803.CrossrefGoogle Scholar

  • 21.

    Patte C, Deruelle P. A critical appraisal of the misoprostol removable, controlled-release vaginal delivery system of labor induction. Int J Womens Health 2015;7:889–99.PubMedWeb of ScienceGoogle Scholar

  • 22.

    Wing DA. Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial. Obstet Gynecol 2008;112:801–12.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 23.

    Dobert M, Brandstetter A, Henrich W, Rawnaq T, Hasselbeck H, Dobert TF, et al. The misoprostol vaginal insert compared with oral misoprostol for labor induction in term pregnancies: a pair-matched case-control study. J Perinat Med 2018;46:309–16.CrossrefPubMedWeb of ScienceGoogle Scholar

  • 24.

    Surbek D, Hösli I, Irion O, Zimmermann R, Vial Y. Misodel® und Misoprostol (off-label) und zur Geburtseinleitung. Available from URL http://www.sggg.ch/fileadmin/user_upload/Formulardaten/49_Misodel_und_Misoprostol__off-label__zur_Geburtseinleitung_ersetzt_No_38.pdf. Accessed April 16, 2019.

  • 25.

    National Institute for Health and Clinical Excellence. Induction of Labour. NICE clinical guideline 70, 2008. Available from URL: https://www.nice.org.uk/guidance/cg70. Accessed April 16, 2019.

  • 26.

    Liston R, Sawchuck D, Young D. No. 197b-Fetal Health Surveillance: Intrapartum Consensus Guideline. J Obstet Gynaecol Can 2018;40:e298–322.Google Scholar

About the article

Corresponding author: Prof. Dr. med. Wolfgang Henrich, Department of Obstetrics and Gynecology, Charité University Hospital Berlin, Charitéplatz 1, 10117 Berlin, Germany; and Department of Obstetrics, Universitätsmedizin Charité, Berlin, Germany, Tel.: +49 30 450 564 072/+49 30 450 564 202

aAleke Brandstetter and Moritz Döbert contributed equally to this work.


Received: 2019-04-29

Accepted: 2019-07-06

Published Online: 2019-08-02

Published in Print: 2019-09-25


Author contributions: PS, AB, MD and WH conceived the study. MD enrolled the participants. AB and MD collected the data. AB, MD, HH and TFD analyzed the data. AB, MD, HH and PS interpreted the data. AB, MD and PS wrote the article. All authors critically reviewed and amended multiple drafts of the manuscript’s concept and outline, as well as the full manuscript, and all authors approved the final draft of the manuscript. All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Conflicts of interest: PS received consultation fees from Ferring Pharmaceuticals with regard to prostaglandin vaginal inserts. None of the other authors of this study have any relevant conflicts of interest (financial, personal, political, intellectual or religious) to disclose. The full disclosure of interests is available to view online as supporting information. The authors have had full control of the primary data and they allow the journal to review the data if requested.

Research funding: This investigator-initiated trial was supported by a grant from Ferring Pharmaceuticals. The contract details are available online as supporting information.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Ethical approval: All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. During this study, no animals were used by any of the authors. This study is a collaboration between Asklepios Hamburg and Charité – University Medical Center Berlin. It is part of the medical thesis of the first author, who is registered and supervised at Charité – University Medical Center Berlin. However, patients were recruited at Asklepios Clinic Barmbek, Hamburg; therefore, the ethical committee was chosen there.

Supplementary material: Ethical committee approval and grant contract.


Citation Information: Journal of Perinatal Medicine, Volume 47, Issue 7, Pages 750–756, ISSN (Online) 1619-3997, ISSN (Print) 0300-5577, DOI: https://doi.org/10.1515/jpm-2019-0153.

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