Dinoprostone Vaginal Insert: A Review in Cervical Ripening
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Dinoprostone vaginal insert (Cervidil®; Propess®), a retrievable vaginal pessary containing 10 mg of dinoprostone [prostaglandin E2 (PGE2)] in a controlled-release drug delivery device, is approved in many countries worldwide for the initiation (or continuation) of cervical ripening in patients at term prior to labour induction. The device is designed to provide a constant and sustained release of dinoprostone to the cervix to promote the complex processes involved in cervical ripening. The vaginal insert is attached to a retrieval system that facilitates easy removal of the device at the onset of labour or in the event of complications. The effectiveness of dinoprostone vaginal insert has been demonstrated in a vast range of randomized clinical trials in women at term. The agent is well tolerated, with a generally favourable safety profile, both maternal and foetal/neonatal. As with all prostaglandin agents used in cervical ripening, dinoprostone vaginal insert is associated with a risk of uterine hyperstimulation. However, this is generally rapidly reversible upon removal of the insert. The demonstrated effectiveness and safety of the device, combined with the benefits of controlled drug release from a simple, single application, and efficient dose control, suggest that dinoprostone vaginal insert is a valuable option for promoting cervical ripening in patients with an unfavourable cervix at term.
During the peer review process, the manufacturer of the dinoprostone vaginal insert was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
Matt Shirley is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
- 1.World Health Organization. WHO recommendations for induction of labour. 2011. http://who.int. Accessed 31 July 2018.
- 2.American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 107: induction of labor. Obstet Gynecol. 2009;114(2 Pt 1):386–97.Google Scholar
- 8.National Institute for Health and Care Excellence. Inducing labour: clinical guideline. 2008. http://www.nice.org.uk. Accessed 31 July 2018.
- 9.Electronic Medicines Compendium. Mysodelle (misoprostol) 200 micrograms vaginal delivery system: summary of product characteristics. 2017. http://www.medicines.org.uk. Accessed 31 July 2018.
- 10.US FDA. Cytotec® misoprostol tablets: US prescribing information. 2018. http://www.fda.gov. Accessed 31 July 2018.
- 11.European Medicines Agency. List of nationally authorised medicinal products: misoprostol (gynaecological indication labour induction). 2018. http://www.ema.europa.eu. Accessed 31 July 2018.
- 12.Ferring Pharmaceuticals Inc. Cervidil® (dinoprostone vaginal insert): US prescribing information. 2016. http://www.ferringusa.com. Accessed 31 July 2018.
- 13.European Medicines Agency. List of nationally authorised medicinal products: dinoprostone. 2017. http://www.ema.europa.eu. Accessed 23 Aug 2018.
- 14.Electronic Medicines Compendium. Propess (dinoprostone) 10 mg vaginal delivery system: summary of product characterisitics. 2017. http://www.medicines.org.uk. Accessed 31 July 2018.
- 15.US FDA. Prepidil® gel (dinoprostone cervical gel): US prescribing information. 2017. http://www.fda.gov. Accessed 31 July 2018.
- 24.Wing DA (for the Misoprostol Vaginal Insert Consortium). Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial. Obstet Gynecol. 2008;112(4):801–12.Google Scholar
- 34.Thomas J, Fairclough A, Kavanagh J, et al. Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term. Cochrane Database Syst Rev. 2014;19(6):CD003101.Google Scholar