Use of dinoprostone vaginal insert for cervical ripening and labor induction in routine obstetrical clinical practice: a multicenter study based on real-world evidence

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Abstract

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.

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About the authors

Oleg R. Baev

Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia; I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)

Author for correspondence.
Email: metod_obsgyn@hotmail.com
ORCID iD: 0000-0001-8572-1971

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; 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)

Russian Federation, 117997, Moscow, Ac. Oparina str., 4; 119991, Moscow, Trubetskaya str., 8-2

Vitaly B. Tskhay

Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of Russia; Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency

Email: tchai@yandex.ru
ORCID iD: 0000-0003-2228-3884

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; Scientific Supervisor in Obstetrics and Gynecology, Federal Siberian Scientific and Clinical Center of the FMBA of Russia

Russian Federation, 660022, Krasnoyarsk, P. Zheleznyak str., 1; 660037, Krasnoyarsk, Kolomenskaya str., 26

Dmitry A. Babich

Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: d_babich@oparina4.ru
ORCID iD: 0000-0002-3264-2038

PhD, Obstetrician-Gynecologist at the1st Maternity Department

Russian Federation, 117997, Moscow, Ac. Oparina str., 4

Vitaly F. Bezhenar

I.P. Pavlov First State Medical University, Ministry of Health of Russia

Email: bez-vitaly@yandex.ru
ORCID iD: 0000-0002-7807-4929

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; Main Supernumerary Specialist Obstetrician-Gynecologist of the Health Committee of St. Petersburg

Russian Federation, 197022, St. Petersburg, Leo Tolstoy str., 6-8

Yuri A. Semenov

Ural Research Institute for Maternal and Child Health, Ministry of Health of Russia

Email: u-sirius@mail.ru
ORCID iD: 0000-0002-3855-3650

Dr. Med. Sci., Director, Urals Research Institute of Maternity and Child Care, Ministry of Health of Russia; Associate Professor at the Department of Obstetrics and Gynecology, South Ural State Medical University, Ministry of Health of Russia,

Russian Federation, 620028, Yekaterinburg, Repin str., 1

Olga F. Serova

Moscow Regional Perinatal Center

Email: olga-serova@yandex.ru
ORCID iD: 0000-0002-4088-4619

Dr. Med. Sci., Professor, Chief External Expert in Obstetrics and Gynaecology at the Moscow Region, Department of Health; Chief Physician, Moscow Regional Perinatal Center; 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

Russian Federation, 143900, Moscow region, Balashikha, Shosse Entuziastov, 12

Karina A. Gabelova

I.P. Pavlov First State Medical University, Ministry of Health of Russia

Email: kgabelova@mail.ru
ORCID iD: 0000-0003-1282-4544

PhD, Associate Professor at the Department of Obstetrics, Gynecology and Neonatology; Head of the Obstetrics Department of Pregnancy Pathology, Clinic for Obstetrics and Gynecology

Russian Federation, 197022, St. Petersburg, Leo Tolstoy str., 6-8

Marina S. Zainulina

I.P. Pavlov First State Medical University, Ministry of Health of Russia; Prof. V.F. Snegirev Maternity Hospital No. 6

Email: zainulina@yandex.ru
ORCID iD: 0000-0002-2622-5000

Dr. Med. Sci, Professor, Department of Obstetrics, Gynecology and Reproduction, Pavlov First State Medical University, Ministry of Health of Russia; Chief Physician, V.F. Snegirev Maternity Hospital No 6

Russian Federation, 197022, St. Petersburg, Leo Tolstoy str., 6-8; 191014, St. Petersburg, Mayakovsky str., 5

Svetlana G. Tsakhilova

Russian University of Medicine, Ministry of Health of Russia

Email: Tsakhilovas@mail.ru
ORCID iD: 0000-0002-4898-6919

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 Federation, 127006, Moscow, Dolgorukovskaya str., 4

Naira H. Omarova

Prof. V.F. Snegirev Maternity Hospital No. 6

Email: omarovanaira@mail.ru

Obstetrician-Gynecologist

Russian Federation, 191014, St. Petersburg, Mayakovsky str., 5

Angelika V. Sheldagayeva

I.P. Pavlov First State Medical University, Ministry of Health of Russia

Email: metod_obsgyn@hotmail.com

Obstetrician-Gynecologist, Senior Laboratory Assistant at the Department, Pavlov First State Medical University, Ministry of Health of Russia

Russian Federation, 197022, St. Petersburg, Leo Tolstoy str., 6-8

Marina M. Menzik

I.S. Berzon Krasnoyarsk Interdistrict Clinical Hospital No. 20

Email: gkb20@mail.ru

Deputy Chief Physician for Obstetrics and Gynecology

Russian Federation, 660123, Krasnoyarsk, Instrumentalnaya str., 12

Yulia E. Semenova

I.S. Berzon Krasnoyarsk Interdistrict Clinical Hospital No. 20

Email: gkb20@mail.ru

Obstetrician-Gynecologist, Department of Pregnancy Pathology

Russian Federation, 660123, Krasnoyarsk, Instrumentalnaya str., 12

Anastasia A. Bryukhanova

I.S. Berzon Krasnoyarsk Interdistrict Clinical Hospital No. 20

Email: gkb20@mail.ru

Head of the Maternity Hospital Admission Department

Russian Federation, 660123, Krasnoyarsk, Instrumentalnaya str., 12

Nadezhda V. Tkacheva

I.S. Berzon Krasnoyarsk Interdistrict Clinical Hospital No. 20

Email: gkb20@mail.ru

Obstetrician-Gynecologist, Department of Pregnancy Pathology

Russian Federation, 660123, Krasnoyarsk, Instrumentalnaya str., 12

Natalia V. Peshkova

Khanty-Mansiysk Autonomous Okrug - Yugra District Clinical Hospital

Email: roddomokb@mail.ru

Head of the Maternity Department

Russian Federation, 628012, Khanty-Mansiysk Autonomous Okrug – Yugra, Khanty-Mansiysk, Kalinina str., 40

Elena N. Vasilkovskaya

Khanty-Mansiysk Autonomous Okrug - Yugra District Clinical Hospital

Email: roddomokb@mail.ru

Deputy Head for Obstetric and Gynecological Care

Russian Federation, 628012, Khanty-Mansiysk Autonomous Okrug – Yugra, Khanty-Mansiysk, Kalinina str., 40

Lyudmila M. Skornyakova

Stavropol Regional Clinical Perinatal Center No. 1

Email: Skornyakova_lm@mail.ru

Deputy Chief Physician for Obstetric and Gynecological Care

Russian Federation, 355029, Stavropol Territory, Stavropol, Semashko str., 3/1 in block 486

Elena L. Muravina

S.S. Yudin City Clinical Hospital, Moscow City Health Department

Email: gkb-yudina@zdrav.mos.ru

PhD, Deputy Chief Physician for Obstetrics and Gynecology

Russian Federation, 115446, Moscow, Kolomenskiy passage, 4, build. 2

Yulia A. Samoylova

I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University); S.S. Yudin City Clinical Hospital, Moscow City Health Department

Email: samoylova2005@yandex.ru

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; 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

Russian Federation, 119991, Moscow, Trubetskaya str., 8-2; 115446, Moscow, Kolomenskiy passage, 4, build. 2

Tatiana V. Rasskazova

S.S. Yudin City Clinical Hospital, Moscow City Health Department

Email: gkb-yudina@zdrav.mos.ru

Obstetrician-Gynecologist, Senior Resident at the First Obstetric Department of Pregnancy Pathology, Maternity Hospital

Russian Federation, 115446, Moscow, Kolomenskiy passage, 4, build. 2

Irina B. Fatkullina

Republican Clinical Perinatal Center of the Ministry of Health of the Republic of Bashkortostan

Email: fib1971@mail.ru
ORCID iD: 0009-0004-9453-6718

Dr. Med. Sci, Deputy Chief Physician, Republican Clinical Perinatal Center, Ministry of Health of the Republic of Bashkortostan; Associate Professor at the Department of Obstetrics and Gynecology No. 1, Bashkir State Medical University, Ministry of Health of Russia

Russian Federation, 450092, Ufa, Batyrskaya str., 41

Alexey L. Frolov

Republican Clinical Perinatal Center of the Ministry of Health of the Republic of Bashkortostan

Email: frolrpc@yandex.ru
ORCID iD: 0009-0004-0678-1503

PhD, Head of the Operating Department No. 2

Russian Federation, 450092, Ufa, Batyrskaya str., 41

Tanzila К. Dalaeva

Republican Clinical Perinatal Center of the Ministry of Health of the Republic of Bashkortostan

Email: tanzila_dalaeva@mail.ru
ORCID iD: 0009-0009-3523-7722

Obstetrician-Gynecologist

Russian Federation, 450092, Ufa, Batyrskaya str., 41

Narkes M. Emasheva

G.G. Kuvatov Republican Clinical Hospital

Email: ufa.rkbkuv@doctorrb.ru

Head of the Department of Obstetric Pathology of Pregnancy

Russian Federation, 450005, Republic of Bashkortostan, Ufa, Dostoevsky str., 132

Olga I. Guskova

Saratov City Clinical Hospital No. 8

Email: sargkb8@mail.ru

Chief of the Perinatal Center

Russian Federation, 410052, Saratov, Odesskaya str., 46A, build. 2

Victoria V. Klishina

V.Yu. Mishekurin Novgorod Regional Clinical Perinatal Center

Email: priemokrd@mail.ru

Deputy Chief Physician for Obstetrics and Gynecology

Russian Federation, 173017, Veliky Novgorod, Derzhavina str., 1

Irina I. Kipriyanova

Regional Perinatal Center

Email: kipriyanovaii@list.ru

PhD, Deputy Chief Physician in Obstetrics

Russian Federation, 454141, Chelyabinsk, Vorovskiy str., 70, build. 12

Kseniya I. Klimkina

Regional Perinatal Center

Email: kipriyanovaii@list.ru

Head of the Obstetric Department of Pregnancy Pathology

Russian Federation, 454141, Chelyabinsk, Vorovskiy str., 70, build. 12

Ksenia Yu. Afanasieva

Moscow Regional Perinatal Center

Email: KseniyaTarkhova@mail.ru

Head of the Department of Pregnancy Pathology

Russian Federation, 143900, Moscow region, Balashikha, Shosse Entuziastov, 12

Marina S. Gracheva

Yekaterinburg Clinical Perinatal Center

Email: terris808061@gmail.com

Head of the Department of Pregnancy Pathology at the 1st Obstetric Hospital

Russian Federation, 620137, Yekaterinburg, Komsomolskaya str., 9

Nizam S. Osmanov

S.-M.A. Omarov Republic of Dagestan Republican Perinatal Center

Email: gbu_rpc@e-dag.ru

Chief Physician

Russian Federation, 367027, Republic of Dagestan, Makhachkala, Akhmed Magomedov str., 2

Lyudmila I. Magomedova

S.-M.A. Omarov Republic of Dagestan Republican Perinatal Center

Email: gbu_rpc@e-dag.ru

Deputy Chief Physician for Obstetric and Gynecological Care

Russian Federation, 367027, Republic of Dagestan, Makhachkala, Akhmed Magomedov str., 2

Amina A. Arslanbekova

S.-M.A. Omarov Republic of Dagestan Republican Perinatal Center

Email: gbu_rpc@e-dag.ru

PhD, Deputy Chief Physician for Clinical and Expert Work

Russian Federation, 367027, Republic of Dagestan, Makhachkala, Akhmed Magomedov str., 2

Tatyana Yu. Pavlova

Ministry of Health of the Republic of Sakha (Yakutia)

Email: tatyanaupavl@mail.ru

PhD, Deputy Minister of Health of the Republic of Sakha (Yakutia)

Russian Federation, 677010, Republic of Sakha (Yakutia), Yakutsk, Lermontov str., 126

Sargylana I. Danilova

M.E. Nikolaev Republic of Sakha (Yakutia) Republican Hospital No. 1 – National Center of Medicine

Email: rb1ncm@gov14.ru

Director

Russian Federation, 677010, Republic of Sakha (Yakutia), Yakutsk, Sergelyakhskoe shosse str., 4

Danara D. Donskaya

Republic of Sakha (Yakutia) Yakut Republican Clinical Hospital

Email: gorclinbol@mail.ru

Deputy Chief Physician for Obstetrics and Gynecology

Russian Federation, 677005, Republic of Sakha (Yakutia), Yakutsk, Stadukhina str., 81

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