Abstract
Aim:
To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with an off-label use of oral misoprostol (OM).
Methods:
Pair-matched case-control study comparing the induction of labor with a retrievable MVI to OM. The primary outcomes were the time from induction to delivery and the cesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.
Results:
One hundred and thirty eight women ≥37/0 weeks pregnant undergoing labor induction with misoprostol were included. The mean time from application to delivery was significantly shorter and the caesarean section rate significantly higher in the MVI group (P<0.01) with an odds ratio of 2.75 (95% CI: 1.21–6.25) in favor of vaginal delivery in the OM group. The mean 5-min Apgar scores and arterial cord pH values were significantly lower in the MVI group. An arterial pH value of 7.10–7.19 was found in 26.1% and 15.9%, and a value <7.10 was found in 4.3% and 0% of MVI and OM cases, respectively.
Conclusion:
The MVI compared with OM significantly shortened the time from application to delivery at the expense of a higher cesarean section rate and negative effects on neonatal outcomes.
Author’s statement
Conflict of interest: Authors state no conflict of interest.
Material and methods: Informed consent: Informed consent has been obtained from all individuals included in this study.
Ethical approval: The research related to human subject use has complied with all the relevant national regulations, and institutional policies, and is in accordance with the tenets of the Helsinki Declaration, and has been approved by the authors’ institutional review board or equivalent committee.
Contributions to Authorship: MD, WH, and PS conceived the study. MD and TR enrolled the participants. MD and AB collected the data. MD, HH, AB, and TFD analyzed the data. MD, HH, and PS interpreted the data. MD, TR and AB drafted the manuscript. MD wrote the article, and PS, WH and LH contributed to the writing. All individuals revised the article critically and approved the final version.
Disclosure of Interest and Source of Funding: The authors report no conflict of interest. No funding was received.
Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT02904317.
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