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Safety of misoprostol vaginal insert for labor induction using standard vs. adjusted retrieval criteria: a comparative cohort study

  • Aleke Brandstetter , Moritz Döbert , Peter Schwaerzler , Timm Fabian Döbert , Hendrik Hasselbeck and Wolfgang Henrich EMAIL logo
Published/Copyright: April 17, 2020
Journal of Perinatal Medicine
From the journal Journal of Perinatal Medicine Volume 48 Issue 5

Abstract

Objective

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

Methods

This was a single-center, comparative cohort study of 138 pregnant women ≥37/0 weeks undergoing labor induction with MVI using standard (69 women; administration for up to 24 h; MVI-24) or adjusted (69 women; administration for up to 10 h; MVI-10) criteria in a tertiary academic center in Germany. The main maternal safety outcomes were the rate of tachysystole and rate of tachysystole requiring tocolysis. Neonatal safety assessments included Apgar score at 5 min and postpartum arterial fetal pH.

Results

Uterine tachysystole occurred in more women in the MVI-24 group compared with the MVI-10 group [47.8% vs. 25.5%; P = 0.001; relative risk (RR) 2.36 (95% confidence interval [CI]: 1.39–4.00)] and as did uterine tachysystole requiring tocolysis [MVI-24: 26.1% vs. MVI-10: 11.6%; P = 0.049; RR 2.25 (95% CI: 1.05–4.83)]. The mean 5-min Apgar scores were 9.64 for the MVI-24 group and 9.87 for the MVI-10 (P = 0.016). Low postpartum umbilical arterial pH values occurred more often in the MVI-24 compared with the MVI-10 group (pH 7.10–7.19: 26.1% vs. 20.3% and pH <7.10: 4.4% vs. 0.0%, respectively).

Conclusion

Adjusted retrieval criteria for MVI of up to 10 h exposure instead of the standard 24 h reduced uterine tachysystole and improved the neonatal outcome.

Keywords: adverse outcome; induction of labor, Misodel®; misoprostol; misoprostol vaginal insert; neonatal adverse effect; tachysystole; uterine hyperstimulation
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
aProf. Peter Schwaerzler deceased 30 October 2018.

Acknowledgments: Editorial assistance was provided by Celia J Parkyn, PhD, and funded by Ferring Pharmaceuticals. Additional statistical analysis support was provided by Kyle Raymond, a former employee of Ferring Pharmaceuticals.

  1. Author contributions: PS, MD, AB and WH conceived the study. MD enrolled the participants. AB and MD collected the data. AB, MD, HH and TFD analyzed the data. MD, AB, 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.

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

  3. Employment or leadership: None declared.

  4. Honorarium: PS has 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.

  5. 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.

  6. Ethical approval: The local Independent Ethics Committee approved the protocol, participant consent form, information sheet and study brochure (PV4803-2, August 4, 2015). The study was performed in accordance with the ethical conduct standards that had their origin in the Declaration of Helsinki and with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Tripartite Guideline on Good Clinical Practice.

  7. Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT03016208.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/jpm-2020-0071).

Received: 2020-02-19
Accepted: 2020-03-08
Published Online: 2020-04-17
Published in Print: 2020-06-25

©2020 Walter de Gruyter GmbH, Berlin/Boston

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  4. Pandemic corona virus issue – how do we respond?
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  23. Assessing the utility of the Healthy Start Screen to predict an elevated Edinburgh Postnatal Depression Scale score
  24. Safety of misoprostol vaginal insert for labor induction using standard vs. adjusted retrieval criteria: a comparative cohort study
  25. Influence of non-pharmacological obstetric interventions on adverse outcomes of childbirth under regional analgesia
  26. Doppler evaluation of the posterior cerebral artery in fetuses with transposition of great arteries
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https://doi.org/10.1515/jpm-2020-0071
Keywords for this article
adverse outcome; induction of labor, Misodel®; misoprostol; misoprostol vaginal insert; neonatal adverse effect; tachysystole; uterine hyperstimulation

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Newborns at risk of COVID-19
  4. Pandemic corona virus issue – how do we respond?
  5. Review
  6. COVID-19 and pregnancy – where are we now? A review
  7. Opinion Paper
  8. Expanding the concept of the professional integrity of obstetrics during a public health emergency
  9. Corner of Academy
  10. COVID-19 infection during pregnancy: fetus as a patient deserves more attention
  11. Are Covid-19-positive mothers dangerous for their term and well newborn babies? Is there an answer?
  12. Short Communication
  13. Novel coronavirus, novel faculty development programs: rapid transition to eLearning during the pandemic
  14. Commentaries
  15. Professionally responsible counseling about birth location during the COVID-19 pandemic
  16. The care of pregnant women during the COVID-19 pandemic – response of a large health system in metropolitan New York
  17. Obituary
  18. Isaac Blickstein, MD
  19. Original Articles – Obstetrics
  20. The impact of general anesthesia on mother-infant bonding for puerperants who undergo emergency cesarean deliveries
  21. The correlation of fetal cardiac function with gestational diabetes mellitus (GDM) and oxidative stress levels
  22. Pregnancy in patients with hemoglobinopathies: 30-year results of a Greek Thalassemia and Sickle Cell Department
  23. Assessing the utility of the Healthy Start Screen to predict an elevated Edinburgh Postnatal Depression Scale score
  24. Safety of misoprostol vaginal insert for labor induction using standard vs. adjusted retrieval criteria: a comparative cohort study
  25. Influence of non-pharmacological obstetric interventions on adverse outcomes of childbirth under regional analgesia
  26. Doppler evaluation of the posterior cerebral artery in fetuses with transposition of great arteries
  27. Original Articles – Newborns
  28. Group B streptococcal transmission rates as determined by PCR
  29. Rates of metabolic acidosis at birth and Apgar score values at 1, 5, and 10 min in term infants: a Swedish cohort study
  30. Short Communication
  31. Placental delayed villous maturation is associated with evidence of chronic fetal hypoxia
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