University of Oulu

Hokkila, E., Kruit, H., Rahkonen, L., Timonen, S., Mattila, M., Laatio, L., … Tihtonen, K. (2019). The efficacy of misoprostol vaginal insert compared with oral misoprostol in the induction of labor of nulliparous women: A randomized national multicenter trial. Acta Obstetricia et Gynecologica Scandinavica, 98(8), 1032–1039. https://doi.org/10.1111/aogs.13580

The efficacy of misoprostol vaginal insert compared with oral misoprostol in the induction of labor of nulliparous women : a randomized national multicenter trial

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Author: Hokkila, Emma1; Kruit, Heidi2,3; Rahkonen, Leena2,3;
Organizations: 1Department of Obstetrics and Gynecology, Lapland Central Hospital, Rovaniemi, Finland
2Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki, Finland
3Helsinki University, Helsinki, Finland
4Department of Obstetrics and Gynecology, Turku University Hospital, Turku, Finland
5Department of Obstetrics and Gynecology, Oulu University Hospital, Oulu, Finland
6Department of Obstetrics and Gynecology, Kuopio University Hospital, Kuopio, Finland
7Department of Obstetrics and Gynecology, Tampere University Hospital, Tampere, Finland
8Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland
9Research, Development and Innovation Center, Tampere University Hospital, Tampere, Finland
Format: article
Version: accepted version
Access: embargoed
Persistent link: http://urn.fi/urn:nbn:fi-fe2019091828599
Language: English
Published: John Wiley & Sons, 2019
Publish Date: 2020-02-16
Description:

Abstract

Introduction: Our objective was to compare the efficacy of a 200‐μg misoprostol vaginal insert vs oral misoprostol regarding the cesarean section rate and the time interval to vaginal delivery in nulliparous women with unfavorable cervix.

Material and methods: In this prospective multicenter trial, 283 nulliparous women at term with Bishop score <6 were randomized to induction of labor with either a misoprostol vaginal insert (n = 140) or oral misoprostol (n = 143). In the oral misoprostol group, a 50‐μg dose of oral misoprostol was administered every 4 hours up to three times during the first day; during the second day, the dose was increased to 100‐μg every 4 hours up to three times during the first day, if necessary. Primary outcome was the cesarean section rate. Secondary outcomes were the time from induction of labor to vaginal delivery, the rate of other induction methods needed, labor augmentation with oxytocin and/or amniotomy, use of tocolytics and adverse neonatal and maternal events.

Results: In the misoprostol vaginal insert group, median time to vaginal delivery was shorter (24.5 hours vs 44.2 hours, P < 0.001), whereas no difference was found in the cesarean section rate (33.8% vs 29.6%, odds ratio [OR] 1.21, 95% confidence interval [CI] 0.66–1.91, P = 0.67). Other induction methods and labor augmentation with oxytocin and/or amniotomy were less frequent in the misoprostol vaginal insert group (OR 0.32, 95% CI 0.18–0.59 and OR 0.56, 95% CI 0.32–0.99, respectively). Need for tocolysis and meconium‐stained amniotic fluid were more common in the misoprostol vaginal insert group (OR 3.63, 95% CI 1.12–11.79 and OR 2.38, 95% CI 1.32–4.29, respectively). Maternal and neonatal adverse events did not differ between groups.

Conclusions: Misoprostol vaginal insert proved to shorten the time to vaginal delivery and to reduce the use of other methods of labor induction and augmentation, but it did not reduce the cesarean section rate compared with oral misoprostol. The benefit of more rapid delivery associated with misoprostol vaginal insert should be weighed against the greater risks for uterine hyperstimulation and meconium‐stained amniotic fluid.

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Series: Acta obstetricia et gynecologica Scandinavica
ISSN: 0001-6349
ISSN-E: 1600-0412
ISSN-L: 0001-6349
Volume: 98
Issue: 8
Pages: 1032 - 1039
DOI: 10.1111/aogs.13580
OADOI: https://oadoi.org/10.1111/aogs.13580
Type of Publication: A1 Journal article – refereed
Field of Science: 3123 Gynaecology and paediatrics
Subjects:
Copyright information: © 2019 Nordic Federation of Societies of Obstetrics and Gynecology. This is the peer reviewed version of the following article: Hokkila, E., Kruit, H., Rahkonen, L., Timonen, S., Mattila, M., Laatio, L., … Tihtonen, K. (2019). The efficacy of misoprostol vaginal insert compared with oral misoprostol in the induction of labor of nulliparous women: A randomized national multicenter trial. Acta Obstetricia et Gynecologica Scandinavica, 98(8), 1032–1039. https://doi.org/10.1111/aogs.13580, which has been published in final form at https://doi.org/10.1111/aogs.13580. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.