Preview

Meditsinskiy sovet = Medical Council

Advanced search

The use of a vaginal therapeutic system with prostaglandin for induction of labor

https://doi.org/10.21518/2079-701X-2022-16-16-84-91

Abstract

   Introduction. Induction of labor is one of the most frequent procedures in modern obstetrics, which reduces the frequency of cesarean section and improves pregnancy outcomes. However, the effectiveness and safety of labor induction methods vary. Currently, the vaginal therapeutic system (SVT) with dinoprostone is certified for use for childbirth in Russia.
   Aim. To conduct a review of the literature data and a pilot study of the effectiveness and safety of the vaginal therapeutic system with dinoprostone for induction of labor.

   Materials and methods. A review of the literature for 2001–2022 devoted to the use of vaginal systems with gradual release of prostaglandin for induction of labor was conducted. Additionally, a prospective observational study of the effectiveness and safety of the dinoprostone system was conducted in 18 pregnant women. The evaluation criteria were: the frequency of labor, the degree of maturation of the cervix on the Bishop scale, as well as the frequency of vaginal delivery.
   Results. Literature data indicate that SVT with dinoprostone has comparable efficacy with other methods of pre-induction / induction of labor. The system with dinoprostone has a lower frequency of the side effect of “tachysystole” than the system with misoprostol. Compared with mechanical methods, SVT is assotiated with a lower frequency of oxytocin use. The use of SVT with dinoprostone showed an efficiency of 77.8% (in terms of the of labor start or cervical ripening). No side effects requiring termination of labor induction were registered in our study.
   Conclusions. Thus, vaginal insertion with prostaglandin E2 – dinoprostone is an effective and safe method of pre-induction of labor. Taking into account the small sample size in our work, it is of interest to continue research in order to obtain more complete data and in comparison with other methods.

About the Authors

O. R. Baev
Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) ; Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
Russian Federation

Oleg R. Baev, Dr. Sci. (Med.), Professor, Head of the Ward, Professor of the Department

1st Maternity Ward

119991

8, Bldg. 2, Trubetskaya St.

Department of Obstetrics, Gynecology, Perinatology and Reproductology

117997

4, Academician Oparin St.

Moscow



V. A. Gusar
Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
Russian Federation

Vladislava A. Gusar, Cand. Sci. (Med.), Senior Researcher

Department of Systems Biology in Reproduction

Laboratory of Applied Transcriptomics

117997

4, Academician Oparin St.

Moscow



A. R. Gaydarova
Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
Russian Federation

Asiyat R. Gaydarova, Postgraduate Student

117997

4, Academician Oparin St.

Moscow



I. V. Edilberg
Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
Russian Federation

Irina V. Edilberg, Postgraduate Student

117997

4, Academician Oparin St.

Moscow



References

1. Баев О. Р. Неудачная попытка стимуляции родов (подготовка шейки матки к родам и родовозбуждение): клинические рекомендации 2021 / О. Р. Баев [и др.] – М., 2021. – 61 с. Режим доступа: https://mz.mosreg.ru/download/document/10106569. – Baev O. R., Petrukhin V. A., Logutova L. S., Zazerskaya I. E., Solodovnikova N. G., Fatkullin I. F. et al. Unsuccessful attempt to induce labour (preparing the cervix for delivery and labour induction): clinical guidelines. 2021. Moscow; 2021. 61 p. (In Russ.) Available at: https://mz.mosreg.ru/download/document/10106569.

2. Sotiriadis A., Petousis S., Thilaganathan B., Figueras F., Martins W. P., Odibo A. O. et al. Maternal and perinatal outcomes after elective induction of labor at 39 weeks in uncomplicated singleton pregnancy: a meta-analysis. Ultrasound Obstet Gynecol. 2019; 53 (1): 26–35. https://doi.org/10.1002/uog.20140.

3. Souter V., Painter I., Sitcov K., Caughey A. B. Maternal and newborn outcomes with elective induction of labor at term. Am J Obstet Gynecol. 2019; 220 (3): 273. e1–273.e11. https://doi.org/10.1016/j.ajog.2019.01.223.

4. Osterman M., Hamilton B., Martin J. A., Driscoll A. K., Valenzuela C. P. Births: Final Data for 2020. Natl Vital Stat Rep. 2021; 70 (17): 1–50. Available at: https://pubmed.ncbi.nlm.nih.gov/35157571/.

5. Bhide A., Sedgwick P., Barrett B., Cupples G., Coates R., Goode R. et al. Prostaglandin insert dinoprostone versus trans- cervical balloon catheter for outpatient labour induction: a randomised controlled trial of feasibility (PROBIT-F). Pilot feasibility Stud. 2020;(6):113. https://doi.org/10.1186/s40814-020-00661-7.

6. Millar E. Maintaining exceptionality: Interrogating gestational limits for abortion. Soc Leg Stud. 2022; 31 (3): 439–58. https://doi.org/10.1177/09646639211032317.

7. Brik M., Mateos S., Fernandez-Buhigas I., Garbayo P., Costa G., Santacruz B. Sonographical predictive markers of failure of induction of labour in term pregnancy. J Obstet Gynaecol. 2017; 37 (2): 179–84. https://doi.org/10.1080/01443615.2016.1229274.

8. Grobman W. A., Bailit J., Lai Y., Reddy U. M., Wapner R. J., Varner M. W. et al. Defining failed induction of labor. Am J Obstet Gynecol. 2018; 218 (1): 122. e1-122.e8. https://doi.org/10.1016/j.ajog.2017.11.556.

9. Freret T. S., Woods G. T., James K. E., Kaimal A. J., Clapp M. A. Incidence of and Risk Factors for Failed Induction of Labor Using a Contemporary Definition. Obstet Gynecol. 2021; 137 (3): 497–504. https://doi.org/10.1097/AOG.0000000000004257.

10. Баев О. Р. Сравнение эффективности и безопасности мифепристона для преиндукции родов при амбулаторном и стационарном применении: протокол рандомизированного контролируемого испытания / О. Р. Баев [и др.] // Акушерство и гинекология. – 2021. – (9): 66–71. https://doi.org/10.18565/aig.2020.9.66-71. – Baev O. R., Karapetyan A. O., Babich D. A., Sukhikh G. T. Comparison of outpatient with inpatient mifepristone usage for cervical ripening: study protocol for a randomized controlled trial. Akusherstvo i Ginekologiya (Russian Federation). 2021; (9): 66–71. (In Russ.) https://doi.org/10.18565/aig.2020.9.66-71.

11. Itoh H., Ishii K., Shigeta N., Itakura A., Hamada H., Nagamatsu T. et al. Efficacy and safety of controlled-release dinoprostone vaginal delivery system (PROPESS) in Japanese pregnant women requiring cervical ripening: Results from a multicenter, randomized, double-blind, placebocontrolled phase III study. J Obstet Gynaecol Res. 2021; 47 (1): 216–225. https://doi.org/10.1111/jog.14472.

12. Shirley M. Dinoprostone Vaginal Insert: A Review in Cervical Ripening. Drugs. 2018; 78 (15): 1615–24. https://doi.org/10.1007/s40265-018-0995-2.

13. Gilstrop M., Sciscione A. Induction of labor-pharmacology methods. Semin Perinatol. 2015; 39 (6): 463–465. https://doi.org/10.1053/j.semperi.2015.07.009.

14. Gupta J., Baev O., Duro Gomez J., Garabedian C., Hellmeyer L., Mahony R. et al. Mechanical methods for induction of labor. Eur J Obstet Gynecol Reprod Biol. 2022; 269: 138–142. https://doi.org/10.1016/j.ejogrb.2021.10.023.

15. Доронина О. К. Индукция родов при доношенной беременности. Цервидил – вагинальная терапевтическая система с динопростоном / О. К. Доронина // Акушерство и гинекология: новости, мнения, обучение. – 2021. – 9 (2): 45–51. https://doi.org/10.33029/2303-9698-2021-9-3-46-51. – Doronina O. K. Labor induction in full-term pregnancy. Cervidil – intravaginal therapeutic system with dinoprostone. Akusherstvo i Ginekologiya: Novosti, Mneniya, Obuchenie. 2021; 9 (2): 45–51. (In Russ.) https://doi.org/10.33029/2303-9698-2021-9-3-46-51.

16. Сакварелидзе Н. Ю. Прогностические предикторы эффективности и безопасности использования вагинальной вставки динопростона в подготовке шейки матки к родам / Н. Ю. Сакварелидзе, С. Г. Цахилова, Ф. А. Паенди // Эффективная фармакотерапия. – 2022. – 18 (24): 12–14. URL: https://umedp.ru/articles/prognosticheskie_prediktory_effektivnosti_i_bezopasnosti_ispolzovaniya_vaginalnoy_vstavki_dinoprosto.html. – Sakvarelidze N. Yu., Tsakhilova S. G., Paendi F. A. Predictive predictors of the efficacy and safety of using the dinoprostone vaginal insert in preparing the cervix for childbirth. Effective Pharmacotherapy. 2022; 18 (24): 12–14. (In Russ.) https://umedp.ru/articles/prognosticheskie_prediktory_effektivnosti_i_bezopasnosti_ispolzovaniya_vaginalnoy_vstavki_dinoprosto.html.

17. Anh N. D., Duc T. A., Ha N.-T. T., Giang D.-T. T., Dat D. T., Thuong P.-T. H. et al. Dinoprostone Vaginal Insert for Induction of Labor in Women with Low-Risk Pregnancies: A Prospective Study. Med Arch (Sarajevo, Bosnia Herzegovina). 2022; 76 (1): 39–44. https://doi.org/10.5455/medarh.2022.76.39-44.

18. Tseng J.-Y., Lin I.-C., Chang W.-H., Yeh C.-C., Horng H.-C., Wang P.-H. Using dinoprostone vaginal insert for induction of labor: A single institute experience. Taiwan J Obstet Gynecol. 2020; 59 (5): 723–727. https://doi.org/10.1016/j.tjog.2020.07.017.

19. Zhao L., Lin Y., Jiang T.-T., Wang L., Li M., Wang Y. et al. Vaginal delivery among women who underwent labor induction with vaginal dinoprostone (PGE2) insert: a retrospective study of 1656 women in China. J Matern Fetal Neonatal Med. 2019; 32 (10): 1721–1727. https://doi.org/10.1080/14767058.2017.1416351.

20. 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. BJOG. 2001; 108 (2): 169–178. https://doi.org/10.1111/j.1471-0528.2001.00039.x.

21. Daykan Y., Biron- Shental T., Navve D., Miller N., Bustan M., Sukenik- Halevy R. Prediction of the efficacy of dinoprostone slow release vaginal insert (Propess) for cervical ripening: A prospective cohort study. J Obstet Gynaecol Res. 2018; 44 (9): 1739–1746. https://doi.org/10.1111/jog.13715.

22. Antonazzo P., Laoreti A., Personeni C., Grossi E., Martinelli A., Cetin I. Vaginal Dinoprostone Versus Intravenous Oxytocin for Labor Induction in Patients Not Responsive to a First Dose of Dinoprostone: A Randomized Prospective Study. Reprod Sci. 2016; 23 (6): 779–784. https://doi.org/10.1177/1933719115618272.

23. Mohr-Sasson A., Schiff E., Sindel O., Suday R. R., Kalter- Farber A., Mashiach R. et al. Second dose of PGE2 vaginal insert versus Foley transcervical balloon for induction of labor after failure of cervical ripening with PGE2 vaginal insert. J Matern Fetal Neonatal Med. 2017; 30 (17): 2074–2077. https://doi.org/10.1080/14767058.2016.1236252.

24. Abdelaziz A., Mahmoud A. A., Ellaithy M. I., Abees S. H. Preinduction cervical ripening using two different dinoprostone vaginal preparations: A randomized clinical trial of tablets and slow release retrievable insert. Taiwan J Obstet Gynecol. 2018; 57 (4): 560–566. https://doi.org/10.1016/j.tjog.2018.06.016.

25. Denoual-Ziad C., Hors Y., Delande I., Lezin B., Herlicoviez M., Dreyfus M. Comparative efficacy of vaginal insert and dinoprostone gel for cervical ripening at term in current practice. J Gynecol Obstet Biol Reprod. 2005; 34 (1): 62–68. https://doi.org/10.1016/S0368-2315(05)82672-9.

26. Facchinetti F., Fontanesi F., Del Giovane C. Pre-induction of labour: comparing dinoprostone vaginal insert to repeated prostaglandin administration: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2012; 25 (10): 1965–1969. https://doi.org/10.3109/14767058.2012.668584.

27. Wei Y., Li X., Zhang Y., Guo Y., Yin B., Chen D. et al. Comparison of Dinoprostone and Oxytocin for the Induction of Labor in Late- Term Pregnancy and the Rate of Cesarean Section: A Retrospective Study in Ten Centers in South China. Med Sci Monit. 2019; 13 (25): 8554–8561. https://doi.org/10.12659/MSM.918330.

28. Rankin K., Chodankar R., Raymond K., Bhaskar S. Misoprostol vaginal insert versus dinoprostone vaginal insert: A comparison of labour and delivery outcomes. Eur J Obstet Gynecol Reprod Biol. 2019; (235): 93–96. https://doi.org/10.1016/j.ejogrb.2018.07.025.

29. De Bonrostro Torralba C., Tejero Cabrejas E. L., Envid Lázaro B. M., Franco Royo M. J., Roca Arquillué M., Campillos Maza J. M. Low-dose vaginal misoprostol vs vaginal dinoprostone insert for induction of labor beyond 41st week: A randomized trial. Acta Obstet Gynecol Scand. 2019; 98 (7): 913–919. https://doi.org/10.1111/aogs.13556.

30. Gaudineau A., Senat M.-V., Ehlinger V., Gallini A., Morin M., Olivier P. et al. Induction of labor at term with vaginal misoprostol or a prostaglandin E2 pessary: a noninferiority randomized controlled trial. Am J Obstet Gynecol. 2021; 225 (5): 542. e1–542. e8. https://doi.org/10.1016/j.ajog.2021.04.226.

31. Mlodawski J., Mlodawska M., Armanska J., Swiercz G., Gluszek S. Misoprostol vs dinoprostone vaginal insert in labour induction: comparison of obstetrical outcome. Sci Rep. 2021; 11 (1): 9077. https://doi.org/10.1038/s41598-021-88723-5.

32. Rugarn O., Tipping D., Powers B., Wing D. A. Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event. BJOG. 2017; 124 (5): 796–803. https://doi.org/10.1111/1471-0528.14147.

33. Crosby D. A., O’Reilly C., McHale H., McAuliffe F. M., Mahony R. A prospective pilot study of Dilapan-S compared with Propess for induction of labour at 41+ weeks in nulliparous pregnancy. Ir J Med Sci. 2018; 187 (3): 693–699. https://doi.org/10.1007/s11845-017-1731-8.

34. Liu Y.-R., Pu C.-X., Wang X.-Y., Wang X.-Y. Double-balloon catheter versus dinoprostone insert for labour induction: a meta-analysis. Arch Gynecol Obstet. 2019; 299 (1): 7–12. https://doi.org/10.1007/s00404-018-4929-8.

35. Diguisto C., Le Gouge A., Arthuis C., Winer N., Parant O., Poncelet C. et al. Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial. PLoS Med. 2021; 18 (2): e1003448. https://doi.org/10.1371/journal.pmed.1003448.

36. Du H., Zhang N., Xiao C.-Y., Sun G.-Q., Zhao Y. Effectiveness of Dinoprostone and Cook’s Balloon for Labor Induction in Primipara Women at Term. Curr Med Sci. 2020; 40 (5): 951–959. https://doi.org/10.1007/s11596-020-2274-1.

37. Wang H., Hong S., Liu Y., Duan Y., Yin H. Controlled-release dinoprostone insert versus Foley catheter for labor induction: a meta-analysis. J Matern Fetal Neonatal Med. 2016; 29 (14): 2382–2388. https://doi.org/10.3109/14767058.2015.1086331.

38. Zhu L., Zhang C., Cao F., Liu Q., Gu X., Xu J. et al. Intracervical Foley catheter balloon versus dinoprostone insert for induction cervical ripening: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018; 97 (48): e13251. https://doi.org/10.1097/MD.0000000000013251.

39. Edwards R. K., Norris M. L., West M. D., Zornes C., Loeffler K. A., Peck J. D. Controlled Release Dinoprostone Insert and Foley Compared to Foley Alone: A Randomized Pilot Trial. Am J Perinatol. 2021; 38 (S01): e57–63. https://doi.org/10.1055/s-0040-1705113.

40. Eser A., Ozkaya E., Abide C. Y., Eser T., Eser G. Y., Abike F. et al. Transcervical Foley balloon catheter and vaginal prostaglandin E2 insert combination vs. vaginal prostaglandin E2 insert only for induction of labor at term: a randomized clinical trial. Arch Gynecol Obstet. 2019; 299 (2): 451–457. https://doi.org/10.1007/s00404-018-4998-8.

41. Wang X., Zhang X., Liu Y., Jiang T., Dai Y., Gong Y. et al. Effect of premature rupture of membranes on time to delivery and outcomes in full-term pregnancies with vaginal dinoprostone- induced labour. Arch Gynecol Obstet. 2020; 301 (2): 369–374. https://doi.org/10.1007/s00404-019-05351-1.

42. Liu H., Yin H., Zhang H., Zhu H., Hu R., Gu W. Dinoprostone pessary for labor induction in Chinese patients with premature rupture of membranes at term: A retrospective cohort. J Obstet Gynaecol Res. 2021; 47 (7): 2356–2362. https://doi.org/10.1111/jog.14749.

43. Athiel Y., Crequit S., Bongiorno M., Sanyan S., Renevier B. Term prelabor rupture of membranes: Foley catheter versus dinoprostone as ripening agent. J Gynecol Obstet Hum Reprod. 2020; 49 (8): 101834. https://doi.org/10.1016/j.jogoh.2020.101834.

44. Hu Y.-P., Zhou D., Li M., Wang Y., Wang L., Sun G.-Q. et al. Use of labor induction with dinoprostone vaginal suppositories in pregnant women with gestational hypertension. J Obstet Gynaecol Res. 2019; 45 (11): 2185–2192. https://doi.org/10.1111/jog.14092.

45. Duro-Gómez J., Garrido-Oyarzún M. F., Rodríguez-Marín A. B., de la Torre González A. J., Arjona-Berral J. E., Castelo- Branco C. Efficacy and safety of misoprostol, dinoprostone and Cook’s balloon for labour induction in women with foetal growth restriction at term. Arch Gynecol Obstet. 2017; 296 (4): 777–781. https://doi.org/10.1007/s00404-017-4492-8.

46. Familiari A., Khalil A., Rizzo G., Odibo A., Vergani P., Buca D. et al. Adverse intrapartum outcome in pregnancies complicated by small for gestational age and late fetal growth restriction undergoing induction of labor with Dinoprostone, Misoprostol or mechanical methods: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2020;(252): 455–467. https://doi.org/10.1016/j.ejogrb.2020.07.020.

47. Di Mascio D., Villalain C., Rizzo G., Morales‐Rosello J., Sileo F. G., Maruotti G. M. et al. Maternal and neonatal outcomes of pregnancies complicated by late fetal growth restriction undergoing induction of labor with dinoprostone compared with cervical balloon: A retrospective, international study. Acta Obstet Gynecol Scand. 2021; 100 (7): 1313–1321. https://doi.org/10.1111/aogs.14135.


Review

For citations:


Baev OR, Gusar VA, Gaydarova AR, Edilberg IV. The use of a vaginal therapeutic system with prostaglandin for induction of labor. Meditsinskiy sovet = Medical Council. 2022;(16):84-91. (In Russ.) https://doi.org/10.21518/2079-701X-2022-16-16-84-91

Views: 673


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2079-701X (Print)
ISSN 2658-5790 (Online)