A prospective, single center study on clinical safety and efficacy of Dinoprostone gel for cervical ripening in pregnant women not in labor
Julienne Katrina B. Beltran, Ramon M. Gonzalez
Oct 2019 DOI 10.35460/2546-1621.2018-0094 Access
Objective: To determine the safety of dinoprostone gel and clinical efficacy for cervical ripening among women for labor induction with a Bishop score of less than 9
Methodology: This is a propsective, single center study where 165 women with a singleton pregnancy, cephalic presentation, at ≥ 36 weeks AOG, candidates for labor induction, and with a Bishop score of less than 9 were subjected to cervical ripening using dinoprostone gel. The primary outcomes were induction success rate, spontaneous vaginal delivery rate, number of dinoprostone gel used and length of time to achieve induction success and deliver.
Results: A median of 1 (range 1-3) dinoprostone gels were used per woman. The median intervals from labor induction to active labor and termination of pregnancy were 260 (range 0-2480) and 485 (range 0-2950) minutes, respectively. The median intervals from dinoprostone insertion to active labor and termination of pregnancy were 480 (range 60-2480) and 820 (range 134-3310) minutes, respectively. Labor was successfully induced in 83%. No adverse events were noted. No significant differences based on parity were detected for the outcomes of dinoprostone dosage and mode of delivery, although in terms of relative proportion, more multiparous women gave birth normally (69% vs. 57%, P = 0.226). There was, however, evidence of increased induction success among women who have given birth previously (94% vs 79%, P = 0.022). The success group generally had higher Bishop scores (i.e. success group had predominantly Bishop 4 and up scores) and higher ages of gestation, more than 50% term patients. There was insufficient evidence to demonstrate a difference between the AOG groups. The duration from labor induction to active phase of labor was shorter for those with BS > 4 (median 240 versus 265 minutes), while the duration from labor induction to termination of pregnancy was shorter for BS ≤ 4 points (478 mins vs 510 mins). However, these were not statistically significant. Similarly, the duration from Dinoprostone insertion to active phase of labor was shorter for those with BS > 4 (median 420 versus 502.5 minutes). The duration from Dinoprostone insertion to termination of pregnancy was also shorter for BS > 4 points (685 mins vs 835 mins). However, these were not statistically significant. The median time from labor induction to active phase was 260 minutes (95% CI 210 to 360 minutes). The median time from labor induction to termination was 490 minutes (95% CI 434 to 590 minutes). None of the following were reported: tachysystole, nausea/ vomiting, diarrhea, vaginal irritations, abdominal pain, back pain, headache, dizziness.
Conclusion: The use of dinoprostone gel is safe. No adverse events have been reported. Induction success was at 83.03%. Vaginal delivery was achieved by 66.67% of the population. Significantly higher induction success and higher vaginal delivery rates were seen for parous group.
- Bishop EH. Pelvic Scoring for Elective Induction. Obstetrics & Gynecology. 1964;24:266–8.
- Danielsen C, Hunter G, Older M, Davis G. Using Bishop Score to Predict Labor Induction Time and Failure Rate. 2008;
- Clark SL, Miller DD, Belfort MA, Dildy GA, Frye DK, Meyers JA. Neonatal and maternal outcomes associated with elective term delivery. American Journal of Obstetrics and Gynecology. 2009 Feb 1;200(2):156–e1.
- Cunningham F, Leveno K, Bloom S, Spong CY, Dashe J. Williams Obstetrics, 24e. McGraw-Hill; 2014.
- Gülmezoglu AM, Crowther CA, Middleton P, Heatley E. Induction of labour for improving birth outcomes for women at or beyond term. Cochrane Database of Systematic Reviews. 2012(6).
- Rouse DJ, Owen J, Hauth JC. Criteria for failed labor induction: prospective evaluation of a standardized protocol. Obstetrics & Gynecology. 2000 Nov 1;96(5):671–7.
- Rouse DJ, Weiner SJ, Bloom SL, Varner MW, Spong CY, Ramin SM, et al. Failed labor induction: toward an objective diagnosis. Obstetrics and Gynecology. 2011 Feb;117(201):267.
- Caughey AB, Sundaram V, Kaimal AJ, Gienger A, Cheng YW, McDonald KM, et al. Systematic review: elective induction of labor versus expectant management of pregnancy. Annals of Internal Medicine. 2009 Aug 18;151(4):252–63.
- Mozurkewich E, Chilimigras J, Koepke E, Keeton K, King VJ. Indications for induction of labour: a best‐evidence review. BJOG: An International Journal of Obstetrics & Gynaecology. 2009 Apr;116(5):626–36.
- Leduc D, Biringer A, Lee L, Dy J, Corbett T, Duperron L, et al. Induction of labour. Journal of Obstetrics and Gynaecology Canada. 2013 Sep 1;35(9):840–57.
- Bueno B, San-Frutos L, Perez-Medina T, Barbancho C, Troyano J, Bajo J. The labor induction: integrated clinical and sonographic variables that predict the outcome. Journal of Perinatology. 2007 Jan;27(1):4.
- Magpoc-Mendoza J, Gonzalez, R. Accuracy of white blood cell count and C reactive protein determination in predicting chorioamnionitis in pregnant women with rupture of membranes. University of Santo Tomas Hospital.
- Towers CV, Briggs GG, Rojas JA. The use of prostaglandin E2 in pregnant patients with asthma. American Journal of Obstetrics and Gynecology. 2004 Jun 1;190(6):1777–80.
- Hawkins JS, Wing DA. Current pharmacotherapy options for labor induction. Expert Opinion on Pharmacotherapy. 2012 Oct 1;13(14):2005–14.
- Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database of Systematic Reviews. 2013(11).
- Boulvain M, Kelly AJ, Irion O. Intracervical prostaglandins for induction of labour. Cochrane Database of Systematic Reviews. 2008(1).
- Macones G. Intrapartum fetal heart rate monitoring: nomenclature, interpretation, and general management principles. Obstetrics and Gynecology. 2009 Jul 1;114(1):192–202.
- Word RA, Li XH, Hnat M, Carrick K. Dynamics of cervical remodeling during pregnancy and parturition: mechanisms and current concepts. In Seminars in Reproductive Medicine. 2007 Jan 25(1):69–79. Thieme Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA..
- Serums B. Vaccines Limited. Chorionic Gonadotrophin (HuCoG®) Product Leaflet. Revised date: January 2013.
- Sharma P, Sharma S, Shergill H. Comparative evaluation of low dose-vaginal misoprostol and intra-cervical dinoprostone for cervical ripening and induction of labour in term pregnancy. International Journal of Reproduction, Contraception, Obstetricsafterwardand Gynecology. 2016;5(12):
- Cengiz H, Yalvac S, Yavuzcan A, Kandemır O. Prediction of successful induction of labour wıth dinoprostone in a homogeneous group of patients. South African Journal of Obstetrics and Gynaecology. 2012;18(1).
- Khan I, Sarker SJ, Hackshaw A. Smaller sample sizes for phase II trials based on exact tests with actual error rates by trading-off their nominal levels of significance and power. British Journal of Cancer. 2012 Nov;107(11):1801.
- Alfirevic Z, Kelly AJ, Dowswell T. Intravenous oxytocin alone for cervical ripening and induction of labour. Cochrane Database of Systematic Reviews. 2009(4).
- Mahendru R, Yadav S. Shortening the induction delivery interval with prostaglandins: a randomized controlled trial of solo or in combination. Journal of the Turkish German Gynecological Association. 2011;12(2):80.
Articles related to the one you are viewing
There are currently no results to show, please try again later
CC BY: Open Access Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/