Standard and adjusted criteria for the use of the misoprostol vaginal insert for labor induction: a comparative cohort study
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Aleke Brandstetter
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.
Acknowledgments
Editorial and medical-writing assistance for the manuscript’s development 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.
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.
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Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/jpm-2019-0153).
©2019 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Corner of Academy
- Hemodynamic factors associated with fetal cardiac remodeling in late fetal growth restriction: a prospective study
- Original Articles – Obstetrics
- Poor sleep quality is associated with perinatal depression. A systematic review of last decade scientific literature and meta-analysis
- The predictive value of serum cancer antigen 125 (CA125) levels on pregnancy outcome in threatened miscarriages
- Pregnancy outcomes after thyroid cancer
- Maternal and perinatal outcomes in external cephalic version: prognostic factors for the success of the technique
- Association of dietary intake below recommendations and micronutrient deficiencies during pregnancy and low birthweight
- The sFlt-1/PlGF ratio values within the <38, 38–85 and >85 brackets as compared to perinatal outcomes
- Effect of bisphenol-A (BPA) on placental biomarkers for inflammation, neurodevelopment and oxidative stress
- Standard and adjusted criteria for the use of the misoprostol vaginal insert for labor induction: a comparative cohort study
- New reference values for biometrical measurements and sonographic estimated fetal weight in twin gestations and comparison to previous normograms
- Simultaneous analysis of bisphenol A fractions in maternal and fetal compartments in early second trimester of pregnancy
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