Use of dinoprostone vaginal insert for cervical ripening and labor induction in routine obstetrical clinical practice: a multicenter study based on real-world evidence
Baev O.R., Tskhay V.B., Babich D.A., Bezhenar V.F., Semenov Yu.A., Serova O.F., Gabelova K.A., Zainulina M.S., Tsakhilova S.G., Omarova N.G., Sheldagayeva A.V., Mentsik M.M., Semenova Yu.E., Bryukhanova A.A., Tkacheva N.V., Peshkova N.V., Vasilkovskaya E.N., Skornyakova L.M., Muravina E.L., Samoylova Yu.A., Rasskazova T.V., Fatkullina I.B., Frolov A.L., Dalaeva T.Kh., Emasheva N.M., Guskova O.I., Klishina V.V., Kipriyanova I.I., Klimkina K.I., Afanasieva K.Yu., Gracheva M.S., Osmanov N.Sh., Magomedova L.I., Arslanbekova A.A., Pavlova T.Yu., Danilova S.N., Donskaya D.D.
Objective: To evaluate the obstetric and neonatal outcomes associated with the use of dinoprostone vaginal insert for cervical ripening and labor induction in routine obstetrical clinical practice.
Materials and methods: Multicenter clinical trial utilizing «real-world evidence» was conducted across 18 hospitals. The study included 503 primiparous and multiparous women with singleton pregnancies in cephalic presentation, gestational ages between 37 and 41+6 weeks, and a cervical Bishop score of 5 or less, who met all inclusion criteria, none with the exclusion criteria, and signed an informed consent form. Vaginal insert containing prostaglandin E2 (dinoprostone) was used for cervical ripening. After 24 h the insert was removed and the patients were re-evaluated. Based on the Bishop score, patients underwent either additional cervical ripening or labor induction.
Results: Labor began in 64.61% of patients before the end of the 24-hour interval while the dinoprostone vaginal insert was still in place. Failed cervical ripening and failed labor induction occurred in 2.78% and 2.78% of patients, respectively. The mean increase in the Bishop score was 2. A vaginal delivery was achieved for 77.14% of patients, while a cesarean was performed on 22.86% of patients. No infectious complications or significant side effects were reported.
Conclusion: The findings from our multicenter real-world evidence study indicate that the dinoprostone vaginal insert is an effective and safe method for cervical ripening and labor induction.
Authors’ contributions: Baev O.R., Tskhay V.B. – conception and design of the study, editing of the manuscript; Baev O.R., Tskhay V.B., Babich D.A., Bezhenar V.F., Semenov Yu.A., Gabelova K.A., Zainulina M.S., Tsakhilova S.G., Omarova N.G., Sheldagayeva A.V., Mentsik M.M., Semenova Yu.E., Bryukhanova A.A., Tkacheva N.V., Peshkova N.V., Vasilkovskaya E.N., Skornyakova L.M., Muravina E.L., Samoylova Yu.A., Rasskazova T.V., Fatkullina I.B., Frolov A.L., Dalaeva T.Kh., Emasheva N.M., Guskova O.I., Klishina V.V., Kipriyanova I.I., Klimkina K.I., Afanasieva K.Yu., Gracheva M.S.,
Osmanov N.Sh., Magomedova L.I., Arslanbekova A.A., Pavlova T.Yu., Danilova S.N., Donskaya D.D. – collection and processing of material; Babich D.A., Baev O.R. – statistical analysis, review of relevant publications, drafting of the manuscript.
Conflicts of interest: The authors have no conflicts of interest to declare.
Funding: There was no funding for this study.
Ethical Approval: The study was reviewed and approved by the Research Ethics Committee of the V.I. Kulakov NMRC for OG&P (Ref. № 06 of 17.08.2023).
Patient Consent for Publication: All patients participating in the study signed an informed consent form. They were informed that the study data would be published without their names being used in written reports or publications.
Authors' Data Sharing Statement: The data supporting the findings of this study are available upon request from the corresponding author after approval from the principal investigator.
For citation: Baev O.R., Tskhay V.B., Babich D.A., Bezhenar V.F., Semenov Yu.A., Serova O.F., Gabelova K.A., Zainulina M.S., Tsakhilova S.G., Omarova N.G., Sheldagayeva A.V., Mentsik M.M., Semenova Yu.E., Bryukhanova A.A., Tkacheva N.V., Peshkova N.V., Vasilkovskaya E.N., Skornyakova L.M., Muravina E.L.,
Samoylova Yu.A., Rasskazova T.V., Fatkullina I.B., Frolov A.L., Dalaeva T.Kh., Emasheva N.M., Guskova O.I., Klishina V.V., Kipriyanova I.I., Klimkina K.I., Afanasieva K.Yu., Gracheva M.S., Osmanov N.Sh., Magomedova L.I., Arslanbekova A.A., Pavlova T.Yu., Danilova S.N., Donskaya D.D. Use of dinoprostone vaginal insert for cervical ripening and labor induction in routine obstetrical clinical practice: a multicenter study based on real-world evidence.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2025; (6): 94-105 (in Russian)
https://dx.doi.org/10.18565/aig.2025.80
Keywords
References
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Received 20.03.2025
Accepted 21.05.2025
About the Authors
Oleg R. Baev, Dr. Med. Sci., Professor, Head of the 1st Maternity Department, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4; Professor at the Department of Obstetrics, Gynecology, Perinatology and Reproductology, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University), 119991, Russia, Moscow, Trubetskaya str., 8-2, metod_obsgyn@hotmail.com, https://orcid.org/0000-0001-8572-1971Vitaly B. Tskhay, Dr. Med. Sci., Professor, Head of the Department of Perinatology, Obstetrics and Gynecology of the Medical Faculty, Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of Russia, 660022, Russia, Krasnoyarsk, P. Zheleznyak str., 1, +7(923)287-21-34, tchai@yandex.ru,
https://orcid.org/0000-0003-2228-3884
Dmitry A. Babich, PhD, Obstetrician-Gynecologist at the1st Maternity Department, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4, +7(903)295-05-05, d_babich@oparina4.ru, https://orcid.org/0000-0002-3264-2038
Vitaly F. Bezhenar, Dr. Med. Sci., Professor, Head of the Departments of Obstetrics, Gynecology and Neonatology/Reproductology, Head of the Clinic of Obstetrics and Gynecology, Pavlov First State Medical University, Ministry of Health of Russia, 197022, Russia, St. Petersburg, Leo Tolstoy str., 6-8; Main Supernumerary Specialist Obstetrician-Gynecologist of the Health Committee of St. Petersburg, +7(812)338-78-66, bez-vitaly@yandex.ru, https://orcid.org/0000-0002-7807-4929
Yuri A. Semenov, Dr. Med. Sci., Director, Urals Research Institute of Maternity and Child Care, Ministry of Health of Russia, 620028, Russia, Yekaterinburg, Repin str., 1, +7(343)371-87-68, u-sirius@mail.ru, https://orcid.org/0000-0002-3855-3650
Olga F. Serova, Dr. Med. Sci., Professor, Chief External Expert in Obstetrics and Gynaecology at the Moscow Region, Department of Health; Chief Physician, Moscow Regional Perinatal Center, 143900, Russia, Moscow region, Balashikha, Shosse Entuziastov, 12; Head of the Department of Obstetrics, Gynecology and Perinatology,
A.I. Burnazyan Federal Medical Biophysical Center of the Federal Medical and Biological Agency of Russia, +7(916)193-46-38, olga-serova@yandex.ru,
https://orcid.org/0000-0002-4088-4619
Karina A. Gabelova, PhD, Associate Professor at the Department of Obstetrics, Gynecology and Neonatology; Head of the Obstetrics Department of Pregnancy Pathology, Clinic for Obstetrics and Gynecology, Pavlov First State Medical University, Ministry of Health of Russia, 197022, Russia, St. Petersburg, Leo Tolstoy str., 6-8,
+7(812)338-78-66, kgabelova@mail.ru
Marina S. Zainulina, Dr. Med. Sci, Professor, Department of Obstetrics, Gynecology and Reproduction, Pavlov First State Medical University, Ministry of Health of Russia, 197022, Russia, St. Petersburg, Leo Tolstoy str., 6-8; Chief Physician, V.F. Snegirev Maternity Hospital No 6, 191014, Russia, St. Petersburg, Mayakovsky str., 5,
+7(812)338-78-66, zainulina@yandex.ru, https://orcid.org/0000-0002-2622-5000
Svetlana G. Tsakhilova, Dr. Med. Sci., Professor, Professor at the Department of Obstetrics, Gynecology and Reproductive Medicine at the N.A. Semashko Scientific and Educational Institute of Clinical Medicine, Russian University of Medicine, Ministry of Health of Russia, 127006, Russia, Moscow, Dolgorukovskaya str., 4, Tsakhilovas@mail.ru, https://orcid.org/0000-0002-4898-6919
Naira H. Omarova, Obstetrician-Gynecologist, V.F. Snegirev Maternity Hospital No 6, 191014, Russia, St. Petersburg, Mayakovsky str., 5, +7(812)73-54-93,
omarovanaira@mail.ru
Angelika V. Sheldagayeva, Obstetrician-Gynecologist, Senior Laboratory Assistant at the Department, Pavlov First State Medical University, Ministry of Health of Russia, 197022, Russia, St. Petersburg, Leo Tolstoy str., 6-8, +7(812)338-7866
Marina M. Menzik, Deputy Chief Physician for Obstetrics and Gynecology, Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after I.S. Berzon, 660123, Russia, Krasnoyarsk, Instrumentalnaya str., 12, +7(391)262-18-96, gkb20@mail.ru
Yulia E. Semenova, Obstetrician-Gynecologist, Department of Pregnancy Pathology, Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after I.S. Berzon,
660123, Russia, Krasnoyarsk, Instrumentalnaya str., 12, +7(391)262-18-96, gkb20@mail.ru
Anastasia A. Bryukhanova, Head of the Maternity Hospital Admission Department, Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after I.S. Berzon,
660123, Russia, Krasnoyarsk, Instrumentalnaya str., 12, +7(391)262-18-96, gkb20@mail.ru
Nadezhda V. Tkacheva, Obstetrician-Gynecologist, Department of Pregnancy Pathology, Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after I.S. Berzon,
660123, Russia, Krasnoyarsk, Instrumentalnaya str., 12, +7(391)262-18-96, gkb20@mail.ru
Natalia V. Peshkova, Head of the Maternity Department, District Clinical Hospital, 628012, Russia, Khanty-Mansiysk Autonomous Okrug – Yugra, Khanty-Mansiysk,
Kalinina str., 40, +7(3467)33-35-71, roddomokb@mail.ru
Elena N. Vasilkovskaya, Deputy Head for Obstetric and Gynecological Care, District Clinical Hospital, 628012, Russia, Khanty-Mansiysk Autonomous Okrug –Yugra,
Khanty-Mansiysk, Kalinina str., 40, +7(3467)33-35-71, roddomokb@mail.ru
Lyudmila M. Skornyakova, Deputy Chief Physician for Obstetric and Gynecological Care, Stavropol Regional Clinical Perinatal Center No. 1, Russia,
355029, Russia, Stavropol Territory, Stavropol, Semashko str., 3/1 in block 486, +7(8652)25-71-59, Skornyakova_lm@mail.ru
Elena L. Muravina, PhD, Deputy Chief Physician for Obstetrics and Gynecology, S.S. Yudin City Clinical Hospital of the Department of Health of the City of Moscow,
115446, Russia, Moscow, Kolomenskiy passage, 4, build. 2, gkb-yudina@zdrav.mos.ru
Yulia A. Samoylova, PhD, Head of the First Obstetric Department of Pregnancy Pathology, Maternity Hospital, S.S. Yudin City Clinical Hospital of the Department of Health of the City of Moscow, 115446, Russia, Moscow, Kolomenskiy passage, 4, build. 2; Teaching Assistant at the Department of Obstetrics, Gynecology and Perinatology of the Faculty of Medicine, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, samoylova2005@yandex.ru
Tatiana V. Rasskazova, Obstetrician-Gynecologist, Senior Resident at the First Obstetric Department of Pregnancy Pathology, Maternity Hospital, S.S. Yudin City Clinical Hospital of the Department of Health of the City of Moscow, 115446, Russia, Moscow, Kolomenskiy passage, 4, build. 2, gkb-yudina@zdrav.mos.ru
Irina B. Fatkullina, Dr. Med. Sci, Deputy Chief Physician, Republican Clinical Perinatal Center, Ministry of Health of the Republic of Bashkortostan,
450106, Russia, Ufa, Batyrskaya str., 41; Associate Professor at the Department of Obstetrics and Gynecology No. 1, Bashkir State Medical University,
Ministry of Health of Russia, fib1971@mail.ru, https://orcid.org/0009-0004-9453-6718
Alexey L. Frolov, PhD, Head of the Operating Department No. 2, Republican Clinical Perinatal Center, Ministry of Health of the Republic of Bashkortostan,
450106, Russia, Ufa, Batyrskaya str., 41, frolrpc@yandex.ru, https://orcid.org/0009-0004-0678-1503
Tanzila К. Dalaeva, Obstetrician-Gynecologist, Republican Clinical Perinatal Center, Ministry of Health of the Republic of Bashkortostan,
450106, Russia, Ufa, Batyrskaya str., 41, tanzila_dalaeva@mail.ru, https://orcid.org/0009-0009-3523-7722
Narkes M. Emasheva, Head of the Department of Obstetric Pathology of Pregnancy, Republican Clinical Hospital named after G.G. Kuvatov,
450005, Russia, Republic of Bashkortostan, Ufa, Dostoevsky str., 132; +7(347)279-03-97, ufa.rkbkuv@doctorrb.ru
Olga I. Guskova, Chief of the Perinatal Center, Saratov City Clinical Hospital No. 8, 410052, Russia, Saratov, Odesskaya str., 46A, build. 2, +7(8452)39-31-10, sargkb8@mail.ru
Victoria V. Klishina, Deputy Chief Physician for Obstetrics and Gynecology, V.Y. Mishekurin Novgorod Regional Clinical Perinatal Center,
173017, Russia, Veliky Novgorod, Derzhavina str., 1, +7(8162)63-73-60, priemokrd@mail.ru
Irina I. Kipriyanova, PhD, Deputy Chief Physician in Obstetrics, Regional Perinatal Center, 454141, Russia, Chelyabinsk, Vorovskiy str., 70, build. 12, +7(351)225-24-27, kipriyanovaii@list.ru
Kseniya I. Klimkina, Head of the Obstetric Department of Pregnancy Pathology, Regional Perinatal Center,
454141, Russia, Chelyabinsk, Vorovskiy str. , 0, build. 12, +7(351)225-24-27
Ksenia Yu. Afanasieva, Head of the Department of Pregnancy Pathology, Moscow Regional Perinatal Center,
143900, Russia, Moscow region, Balashikha, Shosse Entuziastov, 12, +7(495)529-50-13, KseniyaTarkhova@mail.ru
Marina S. Gracheva, Head of the Department of Pregnancy Pathology at the 1st Obstetric Hospital, Yekaterinburg Clinical Perinatal Center,
620137, Russia, Yekaterinburg, Komsomolskaya str., 9, +7(343) 374-51-08, terris808061@gmail.com
Nizam S. Osmanov, Chief Physician, Republican Perinatal Center named after Omarov S.-M.A., 367027, Russia, Republic of Dagestan, Makhachkala, Akhmed Magomedov str., 2, +7(8722)64-01-28, gbu_rpc@e-dag.ru
Lyudmila I. Magomedova, Deputy Chief Physician for Obstetric and Gynecological Care, Republican Perinatal Center named after Omarov S.-M.A.,
367027, Russia, Republic of Dagestan, Makhachkala, Akhmed Magomedov str., 2, +7(8722)64-01-26, gbu_rpc@e-dag.ru
Amina A. Arslanbekova, PhD, Deputy Chief Physician for Clinical and Expert Work, Republican Perinatal Center named after Omarov S.-M.A.,
367027, Russia, Republic of Dagestan, Makhachkala, Akhmed Magomedov str., 2, +7(8722)64-01-28, gbu_rpc@e-dag.ru
Tatyana Yu. Pavlova, PhD, Deputy Minister of Health of the Republic of Sakha (Yakutia), 677010, Russia, Republic of Sakha (Yakutia), Yakutsk, Lermontov str., 126, tatyanaupavl@mail.ru
Sargylana I. Danilova, Director, Republican Hospital No. 1 – National Center of Medicine named after M.E. Nikolaev,
677010, Russia, Republic of Sakha (Yakutia), Yakutsk, Sergelyakhskoe shosse str., 4, rb1ncm@gov14.ru
Danara D. Donskaya, Deputy Chief Physician for Obstetrics and Gynecology, Yakut Republican Clinical Hospital,
677005, Russia, Republic of Sakha (Yakutia), Yakutsk, Stadukhina str., 81, +7(4112)43-20-41, gorclinbol@mail.ru
Corresponding authors: Oleg R. Baev, o_baev@oparina4.ru; Dmitry A. Babich, d_babich@oparina4.ru