Skip to main content
Top
Published in: Drugs 15/2018

01-10-2018 | Adis Drug Evaluation

Dinoprostone Vaginal Insert: A Review in Cervical Ripening

Author: Matt Shirley

Published in: Drugs | Issue 15/2018

Login to get access

Abstract

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.
Literature
1.
2.
go back to reference American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 107: induction of labor. Obstet Gynecol. 2009;114(2 Pt 1):386–97. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 107: induction of labor. Obstet Gynecol. 2009;114(2 Pt 1):386–97.
3.
go back to reference Grobman WA, Rice MM, Reddy UM, et al. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379(6):513–23.CrossRef Grobman WA, Rice MM, Reddy UM, et al. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379(6):513–23.CrossRef
4.
go back to reference Burnett JE Jr. Preinduction scoring: an objective approach to induction of labor. Obstet Gynecol. 1966;28(4):479–83.PubMed Burnett JE Jr. Preinduction scoring: an objective approach to induction of labor. Obstet Gynecol. 1966;28(4):479–83.PubMed
5.
go back to reference Leduc D, Biringer A, Lee L, et al. SOGC clinical practice guideline: induction of labour. J Obstet Gynaecol Can. 2013;35(9):840–57.CrossRef Leduc D, Biringer A, Lee L, et al. SOGC clinical practice guideline: induction of labour. J Obstet Gynaecol Can. 2013;35(9):840–57.CrossRef
6.
go back to reference Tenore JL. Methods for cervical ripening and induction of labor. Am Fam Physician. 2003;67(10):2123–8.PubMed Tenore JL. Methods for cervical ripening and induction of labor. Am Fam Physician. 2003;67(10):2123–8.PubMed
7.
go back to reference Bakker R, Pierce S, Myers D. The role of prostaglandins E1 and E2, dinoprostone, and misoprostol in cervical ripening and the induction of labor: a mechanistic approach. Arch Gynecol Obstet. 2017;296(2):167–79.CrossRef Bakker R, Pierce S, Myers D. The role of prostaglandins E1 and E2, dinoprostone, and misoprostol in cervical ripening and the induction of labor: a mechanistic approach. Arch Gynecol Obstet. 2017;296(2):167–79.CrossRef
11.
go back to reference European Medicines Agency. List of nationally authorised medicinal products: misoprostol (gynaecological indication labour induction). 2018. http://www.ema.europa.eu. Accessed 31 July 2018. European Medicines Agency. List of nationally authorised medicinal products: misoprostol (gynaecological indication labour induction). 2018. http://​www.​ema.​europa.​eu. Accessed 31 July 2018.
16.
go back to reference Lyrenäs S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. Br J Obstet Gynaecol. 2001;108(2):169–78. Lyrenäs S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. Br J Obstet Gynaecol. 2001;108(2):169–78.
17.
go back to reference Goharkhay N, Stanczyk FZ, Gentzschein E, et al. Plasma prostaglandin E2 metabolite levels during labor induction with a sustained-release prostaglandin E2 vaginal insert. J Soc Gynecol Investig. 2000;7(6):338–42.CrossRef Goharkhay N, Stanczyk FZ, Gentzschein E, et al. Plasma prostaglandin E2 metabolite levels during labor induction with a sustained-release prostaglandin E2 vaginal insert. J Soc Gynecol Investig. 2000;7(6):338–42.CrossRef
18.
go back to reference Goharkhay N, Stanczyk FZ, Zhang L, et al. Plasma progesterone, dehydroepiandrosterone sulfate and estriol levels during labor induction with a sustained-release prostaglandin E2 vaginal insert. J Matern Fetal Med. 2001;10(3):197–202.CrossRef Goharkhay N, Stanczyk FZ, Zhang L, et al. Plasma progesterone, dehydroepiandrosterone sulfate and estriol levels during labor induction with a sustained-release prostaglandin E2 vaginal insert. J Matern Fetal Med. 2001;10(3):197–202.CrossRef
19.
go back to reference Rayburn WF, Anderson JC, Smith CV, et al. Uterine and fetal Doppler flow changes after intravaginal prostaglandin E2 therapy for cervical ripening. Am J Obstet Gynecol. 1991;165(1):125–6.CrossRef Rayburn WF, Anderson JC, Smith CV, et al. Uterine and fetal Doppler flow changes after intravaginal prostaglandin E2 therapy for cervical ripening. Am J Obstet Gynecol. 1991;165(1):125–6.CrossRef
20.
go back to reference Keskin HL, Kabacaoğlu G, Seçen EI, et al. Effects of intravaginally inserted controlled-release dinoprostone and oxytocin for labor induction on umbilical cord blood gas parameters. J Turk Ger Gynecol Assoc. 2012;13(4):257–60.CrossRef Keskin HL, Kabacaoğlu G, Seçen EI, et al. Effects of intravaginally inserted controlled-release dinoprostone and oxytocin for labor induction on umbilical cord blood gas parameters. J Turk Ger Gynecol Assoc. 2012;13(4):257–60.CrossRef
21.
go back to reference Rayburn WF, Wapner RJ, Barss VA, et al. An intravaginal controlled-release prostaglandin E2 pessary for cervical ripening and initiation of labor at term. Obstet Gynecol. 1992;79(3):374–9.CrossRef Rayburn WF, Wapner RJ, Barss VA, et al. An intravaginal controlled-release prostaglandin E2 pessary for cervical ripening and initiation of labor at term. Obstet Gynecol. 1992;79(3):374–9.CrossRef
22.
go back to reference Witter FR, Mercer BM. Improved intravaginal controlled-release prostaglandin E2 insert for cervical ripening at term. J Matern Fetal Med. 1996;5(2):64–9.PubMed Witter FR, Mercer BM. Improved intravaginal controlled-release prostaglandin E2 insert for cervical ripening at term. J Matern Fetal Med. 1996;5(2):64–9.PubMed
23.
go back to reference Witter FR, Rocco LE, Johnson TRB. A randomized trial of prostaglandin E2 in a controlled-release vaginal pessary for cervical ripening at term. Am J Obstet Gynecol. 1992;166(3):830–4.CrossRef Witter FR, Rocco LE, Johnson TRB. A randomized trial of prostaglandin E2 in a controlled-release vaginal pessary for cervical ripening at term. Am J Obstet Gynecol. 1992;166(3):830–4.CrossRef
24.
go back to reference 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. 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.
25.
go back to reference Wing DA, Brown R, Plante LA, et al. Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2013;122(2 Pt 1):201–9.CrossRef Wing DA, Brown R, Plante LA, et al. Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2013;122(2 Pt 1):201–9.CrossRef
26.
go back to reference Wing DA, Ortiz-Omphroy G, Paul RH. A comparison of intermittent vaginal administration of misoprostol with continuous dinoprostone for cervical ripening and labor induction. Am J Obstet Gynecol. 1997;177(3):612–8.CrossRef Wing DA, Ortiz-Omphroy G, Paul RH. A comparison of intermittent vaginal administration of misoprostol with continuous dinoprostone for cervical ripening and labor induction. Am J Obstet Gynecol. 1997;177(3):612–8.CrossRef
27.
go back to reference Sanchez-Ramos L, Peterson DE, Delke I, et al. Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: a randomized trial. Obstet Gynecol. 1998;91(3):401–5.CrossRef Sanchez-Ramos L, Peterson DE, Delke I, et al. Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: a randomized trial. Obstet Gynecol. 1998;91(3):401–5.CrossRef
28.
go back to reference Garry D, Figueroa R, Kalish RB, et al. Randomized controlled trial of vaginal misoprostol versus dinoprostone vaginal insert for labor induction. J Matern Fetal Neonatal Med. 2003;13(4):254–9.CrossRef Garry D, Figueroa R, Kalish RB, et al. Randomized controlled trial of vaginal misoprostol versus dinoprostone vaginal insert for labor induction. J Matern Fetal Neonatal Med. 2003;13(4):254–9.CrossRef
29.
go back to reference Bolnick JM, Velazquez MD, Gonzalez JL, et al. Randomized trial between two active labor management protocols in the presence of an unfavorable cervix. Am J Obstet Gynecol. 2004;190(1):124–8.CrossRef Bolnick JM, Velazquez MD, Gonzalez JL, et al. Randomized trial between two active labor management protocols in the presence of an unfavorable cervix. Am J Obstet Gynecol. 2004;190(1):124–8.CrossRef
30.
go back to reference Rouzi AA, Alsibiani S, Mansouri N, et al. Randomized clinical trial between hourly titrated oral misoprostol and vaginal dinoprostone for induction of labor. Am J Obstet Gynecol. 2014;210(1):56.e1–6.CrossRef Rouzi AA, Alsibiani S, Mansouri N, et al. Randomized clinical trial between hourly titrated oral misoprostol and vaginal dinoprostone for induction of labor. Am J Obstet Gynecol. 2014;210(1):56.e1–6.CrossRef
31.
go back to reference Wang X, Yang A, Ma Q, et al. Comparative study of titrated oral misoprostol solution and vaginal dinoprostone for labor induction at term pregnancy. Arch Gynecol Obstet. 2016;294(3):495–503.CrossRef Wang X, Yang A, Ma Q, et al. Comparative study of titrated oral misoprostol solution and vaginal dinoprostone for labor induction at term pregnancy. Arch Gynecol Obstet. 2016;294(3):495–503.CrossRef
32.
go back to reference Austin SC, Sanchez-Ramos L, Adair CD. Labor induction with intravaginal misoprostol compared with the dinoprostone vaginal insert: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010;202(6):624.e1–9.CrossRef Austin SC, Sanchez-Ramos L, Adair CD. Labor induction with intravaginal misoprostol compared with the dinoprostone vaginal insert: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010;202(6):624.e1–9.CrossRef
33.
go back to reference Alfirevic Z, Keeney E, Dowswell T, et al. Labour induction with prostaglandins: a systematic review and network meta-analysis. BMJ. 2015;350:h217.CrossRef Alfirevic Z, Keeney E, Dowswell T, et al. Labour induction with prostaglandins: a systematic review and network meta-analysis. BMJ. 2015;350:h217.CrossRef
34.
go back to reference 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. 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.
35.
go back to reference Hughes EG, Kelly AJ, Kavanagh J. Dinoprostone vaginal insert for cervical ripening and labor induction: a meta-analysis. Obstet Gynecol. 2001;97(5 Pt 2):847–55.PubMed Hughes EG, Kelly AJ, Kavanagh J. Dinoprostone vaginal insert for cervical ripening and labor induction: a meta-analysis. Obstet Gynecol. 2001;97(5 Pt 2):847–55.PubMed
36.
go back to reference Zeng X, Zhang Y, Tian Q, et al. Efficiency of dinoprostone insert for cervical ripening and induction of labor in women of full-term pregnancy compared with dinoprostone gel: a meta-analysis. Drug Discov Ther. 2015;9(3):165–72.CrossRef Zeng X, Zhang Y, Tian Q, et al. Efficiency of dinoprostone insert for cervical ripening and induction of labor in women of full-term pregnancy compared with dinoprostone gel: a meta-analysis. Drug Discov Ther. 2015;9(3):165–72.CrossRef
37.
go back to reference Cromi A, Ghezzi F, Agosti M, et al. Is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix? A randomized study. Am J Obstet Gynecol. 2011;204(4):338.e1–7.CrossRef Cromi A, Ghezzi F, Agosti M, et al. Is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix? A randomized study. Am J Obstet Gynecol. 2011;204(4):338.e1–7.CrossRef
38.
go back to reference Edwards RK, Szychowski JM, Berger JL, et al. Foley catheter compared with the controlled-release dinoprostone insert: a randomized controlled trial. Obstet Gynecol. 2014;123(6):1280–7.CrossRef Edwards RK, Szychowski JM, Berger JL, et al. Foley catheter compared with the controlled-release dinoprostone insert: a randomized controlled trial. Obstet Gynecol. 2014;123(6):1280–7.CrossRef
39.
go back to reference Cromi A, Ghezzi F, Uccella S, et al. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012;207(2):125.e1–7.CrossRef Cromi A, Ghezzi F, Uccella S, et al. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012;207(2):125.e1–7.CrossRef
40.
go back to reference Wang H, Hong S, Liu Y, et al. Controlled-release dinoprostone insert versus Foley catheter for labor induction: a meta-analysis. J Matern Fetal Neonatal Med. 2016;29(14):2382–8.PubMed Wang H, Hong S, Liu Y, et al. Controlled-release dinoprostone insert versus Foley catheter for labor induction: a meta-analysis. J Matern Fetal Neonatal Med. 2016;29(14):2382–8.PubMed
41.
go back to reference Rugarn O, Tipping D, Powers B, et al. Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event. BJOG. 2017;124(5):796–803.CrossRef Rugarn O, Tipping D, Powers B, et al. Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event. BJOG. 2017;124(5):796–803.CrossRef
42.
go back to reference Pevzner L, Alfirevic Z, Powers BL, et al. Cardiotocographic abnormalities associated with misoprostol and dinoprostone cervical ripening and labor induction. Eur J Obstet Gynecol Reprod Biol. 2011;156(2):144–8.CrossRef Pevzner L, Alfirevic Z, Powers BL, et al. Cardiotocographic abnormalities associated with misoprostol and dinoprostone cervical ripening and labor induction. Eur J Obstet Gynecol Reprod Biol. 2011;156(2):144–8.CrossRef
43.
go back to reference Rath W. A clinical evaluation of controlled-release dinoprostone for cervical ripening—a review of current evidence in hospital and outpatient settings. J Perinat Med. 2005;33(6):491–9.CrossRef Rath W. A clinical evaluation of controlled-release dinoprostone for cervical ripening—a review of current evidence in hospital and outpatient settings. J Perinat Med. 2005;33(6):491–9.CrossRef
44.
go back to reference Pevzner L, Rayburn WF, Rumney P, et al. Factors predicting successful labor induction with dinoprostone and misoprostol vaginal inserts. Obstet Gynecol. 2009;114(2 Pt 1):261–7.CrossRef Pevzner L, Rayburn WF, Rumney P, et al. Factors predicting successful labor induction with dinoprostone and misoprostol vaginal inserts. Obstet Gynecol. 2009;114(2 Pt 1):261–7.CrossRef
45.
go back to reference Hiersch L, Borovich A, Gabbay-Benziv R, et al. Can we predict successful cervical ripening with prostaglandin E2 vaginal inserts? Arch Gynecol Obstet. 2017;295(2):343–9.CrossRef Hiersch L, Borovich A, Gabbay-Benziv R, et al. Can we predict successful cervical ripening with prostaglandin E2 vaginal inserts? Arch Gynecol Obstet. 2017;295(2):343–9.CrossRef
46.
go back to reference Edwards RK, Szychowski JM, Bodea-Braescu AV, et al. Foley catheter for induction of labor: potential barriers to adopting the technique. J Perinatol. 2015;35(12):996–9.CrossRef Edwards RK, Szychowski JM, Bodea-Braescu AV, et al. Foley catheter for induction of labor: potential barriers to adopting the technique. J Perinatol. 2015;35(12):996–9.CrossRef
47.
go back to reference Heinemann J, Gillen G, Sanchez-Ramos L, et al. Do mechanical methods of cervical ripening increase infectious morbidity? A systematic review. Am J Obstet Gynecol. 2008;199(2):177–88.CrossRef Heinemann J, Gillen G, Sanchez-Ramos L, et al. Do mechanical methods of cervical ripening increase infectious morbidity? A systematic review. Am J Obstet Gynecol. 2008;199(2):177–88.CrossRef
Metadata
Title
Dinoprostone Vaginal Insert: A Review in Cervical Ripening
Author
Matt Shirley
Publication date
01-10-2018
Publisher
Springer International Publishing
Published in
Drugs / Issue 15/2018
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-018-0995-2

Other articles of this Issue 15/2018

Drugs 15/2018 Go to the issue