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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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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作者简介

Oleg 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)

编辑信件的主要联系方式.
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)

俄罗斯联邦, 117997, Moscow, Ac. Oparina str., 4; 119991, Moscow, Trubetskaya str., 8-2

Vitaly 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

俄罗斯联邦, 660022, Krasnoyarsk, P. Zheleznyak str., 1; 660037, Krasnoyarsk, Kolomenskaya str., 26

Dmitry 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

俄罗斯联邦, 117997, Moscow, Ac. Oparina str., 4

Vitaly 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

俄罗斯联邦, 197022, St. Petersburg, Leo Tolstoy str., 6-8

Yuri 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,

俄罗斯联邦, 620028, Yekaterinburg, Repin str., 1

Olga 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

俄罗斯联邦, 143900, Moscow region, Balashikha, Shosse Entuziastov, 12

Karina 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

俄罗斯联邦, 197022, St. Petersburg, Leo Tolstoy str., 6-8

Marina 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

俄罗斯联邦, 197022, St. Petersburg, Leo Tolstoy str., 6-8; 191014, St. Petersburg, Mayakovsky str., 5

Svetlana 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

俄罗斯联邦, 127006, Moscow, Dolgorukovskaya str., 4

Naira Omarova

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

Email: omarovanaira@mail.ru

Obstetrician-Gynecologist

俄罗斯联邦, 191014, St. Petersburg, Mayakovsky str., 5

Angelika 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

俄罗斯联邦, 197022, St. Petersburg, Leo Tolstoy str., 6-8

Marina Menzik

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

Email: gkb20@mail.ru

Deputy Chief Physician for Obstetrics and Gynecology

俄罗斯联邦, 660123, Krasnoyarsk, Instrumentalnaya str., 12

Yulia Semenova

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

Email: gkb20@mail.ru

Obstetrician-Gynecologist, Department of Pregnancy Pathology

俄罗斯联邦, 660123, Krasnoyarsk, Instrumentalnaya str., 12

Anastasia Bryukhanova

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

Email: gkb20@mail.ru

Head of the Maternity Hospital Admission Department

俄罗斯联邦, 660123, Krasnoyarsk, Instrumentalnaya str., 12

Nadezhda Tkacheva

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

Email: gkb20@mail.ru

Obstetrician-Gynecologist, Department of Pregnancy Pathology

俄罗斯联邦, 660123, Krasnoyarsk, Instrumentalnaya str., 12

Natalia Peshkova

Khanty-Mansiysk Autonomous Okrug - Yugra District Clinical Hospital

Email: roddomokb@mail.ru

Head of the Maternity Department

俄罗斯联邦, 628012, Khanty-Mansiysk Autonomous Okrug – Yugra, Khanty-Mansiysk, Kalinina str., 40

Elena Vasilkovskaya

Khanty-Mansiysk Autonomous Okrug - Yugra District Clinical Hospital

Email: roddomokb@mail.ru

Deputy Head for Obstetric and Gynecological Care

俄罗斯联邦, 628012, Khanty-Mansiysk Autonomous Okrug – Yugra, Khanty-Mansiysk, Kalinina str., 40

Lyudmila Skornyakova

Stavropol Regional Clinical Perinatal Center No. 1

Email: Skornyakova_lm@mail.ru

Deputy Chief Physician for Obstetric and Gynecological Care

俄罗斯联邦, 355029, Stavropol Territory, Stavropol, Semashko str., 3/1 in block 486

Elena 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

俄罗斯联邦, 115446, Moscow, Kolomenskiy passage, 4, build. 2

Yulia 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

俄罗斯联邦, 119991, Moscow, Trubetskaya str., 8-2; 115446, Moscow, Kolomenskiy passage, 4, build. 2

Tatiana 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

俄罗斯联邦, 115446, Moscow, Kolomenskiy passage, 4, build. 2

Irina 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

俄罗斯联邦, 450092, Ufa, Batyrskaya str., 41

Alexey 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

俄罗斯联邦, 450092, Ufa, Batyrskaya str., 41

Tanzila 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

俄罗斯联邦, 450092, Ufa, Batyrskaya str., 41

Narkes Emasheva

G.G. Kuvatov Republican Clinical Hospital

Email: ufa.rkbkuv@doctorrb.ru

Head of the Department of Obstetric Pathology of Pregnancy

俄罗斯联邦, 450005, Republic of Bashkortostan, Ufa, Dostoevsky str., 132

Olga Guskova

Saratov City Clinical Hospital No. 8

Email: sargkb8@mail.ru

Chief of the Perinatal Center

俄罗斯联邦, 410052, Saratov, Odesskaya str., 46A, build. 2

Victoria Klishina

V.Yu. Mishekurin Novgorod Regional Clinical Perinatal Center

Email: priemokrd@mail.ru

Deputy Chief Physician for Obstetrics and Gynecology

俄罗斯联邦, 173017, Veliky Novgorod, Derzhavina str., 1

Irina Kipriyanova

Regional Perinatal Center

Email: kipriyanovaii@list.ru

PhD, Deputy Chief Physician in Obstetrics

俄罗斯联邦, 454141, Chelyabinsk, Vorovskiy str., 70, build. 12

Kseniya Klimkina

Regional Perinatal Center

Email: kipriyanovaii@list.ru

Head of the Obstetric Department of Pregnancy Pathology

俄罗斯联邦, 454141, Chelyabinsk, Vorovskiy str., 70, build. 12

Ksenia Afanasieva

Moscow Regional Perinatal Center

Email: KseniyaTarkhova@mail.ru

Head of the Department of Pregnancy Pathology

俄罗斯联邦, 143900, Moscow region, Balashikha, Shosse Entuziastov, 12

Marina Gracheva

Yekaterinburg Clinical Perinatal Center

Email: terris808061@gmail.com

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

俄罗斯联邦, 620137, Yekaterinburg, Komsomolskaya str., 9

Nizam Osmanov

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

Email: gbu_rpc@e-dag.ru

Chief Physician

俄罗斯联邦, 367027, Republic of Dagestan, Makhachkala, Akhmed Magomedov str., 2

Lyudmila 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

俄罗斯联邦, 367027, Republic of Dagestan, Makhachkala, Akhmed Magomedov str., 2

Amina 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

俄罗斯联邦, 367027, Republic of Dagestan, Makhachkala, Akhmed Magomedov str., 2

Tatyana 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)

俄罗斯联邦, 677010, Republic of Sakha (Yakutia), Yakutsk, Lermontov str., 126

Sargylana Danilova

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

Email: rb1ncm@gov14.ru

Director

俄罗斯联邦, 677010, Republic of Sakha (Yakutia), Yakutsk, Sergelyakhskoe shosse str., 4

Danara Donskaya

Republic of Sakha (Yakutia) Yakut Republican Clinical Hospital

Email: gorclinbol@mail.ru

Deputy Chief Physician for Obstetrics and Gynecology

俄罗斯联邦, 677005, Republic of Sakha (Yakutia), Yakutsk, Stadukhina str., 81

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