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Synthetic osmotic dilators in the induction of labour-An international multicentre observational study

J. Gupta, R. Chodankar, O. Baev, F. Bahlmann, E. Brega, A. Gala, L. Hellmeyer, L. Hruban, J. Maier, P. Mehta, A. Murthy, M. Ritter, A. Saad, R. Shmakov, A. Suneja, J. Zahumensky, D. Gdovinova,

. 2018 ; 229 (-) : 70-75. [pub] 20180803

Language English Country Ireland

Document type Journal Article, Multicenter Study, Observational Study

Persistent link   https://www.medvik.cz/link/bmc19012463

INTRODUCTION: To evaluate the effects of synthetic osmotic dilators (Dilapan-S/ Dilasoft) in women who required induction of labour in a large prospective multicentre international observational study. MATERIALS AND METHODS: Primary outcomes were duration of Dilapan-S/Dilasoft insertion (hours), total induction - delivery interval (hours) and the rate of vaginal deliveries within 24 h (%). Secondary outcomes were the number of dilators inserted, Bishop score increase after extraction of Dilapan-S/Dilasoft, complications during induction (uterine contractions, uterine tachysystole and hyperstimulation, effect on the fetus) and post induction (infections and neonatal outcomes), agents / procedures used for subsequent induction of labour, immediate rate of spontaneous labours following cervical ripening period, rate of spontaneous vaginal deliveries, rate of instrumental vaginal deliveries and caesarean sections. RESULTS: Total of 543 women were recruited across 11 study sites, of which, 444 women were eligible for analysis. With Dilapan-S/Dilasoft use of <12 h (n = 188) the overall vaginal delivery rate was 76.6% with 45.7% of these births occurring within 24 h, 66% within 36 h and 75.5% within 48 h from insertion of Dilapan-S/Dilasoft. The mean insertion-delivery interval for this group was 24.3(±10.4) hours. With Dilapan-S/Dilasoft use of >12 h (n = 256), the overall vaginal delivery rate was 64.8%, with 16% of these births occurring within 24 h, 48.4% within 36 h and 54.7% within 48 h from insertion of Dilapan-S/Dilasoft. The mean insertion-delivery interval for this group was 39.1(±29.2) hours. The mean gain in the Bishops score was +3.6(±2.3). The mean number of Dilapan-S/Dilasoft dilators used was 3.8 (±1.1). The overall rate of caesarean section was 30.1%. The overall complication rate was low including infection risk. No adverse neonatal outcome was attributable to the use of Dilapan-S/Dilasoft. CONCLUSION: Dilapan-S/Dilasoft are safe and effective methods for cervical ripening. Their use is associated with low maternal and neonatal complication rates. Future research should aim at level I clinical trials comparing Dilapan-S to other mechanical or pharmacological cervical ripening agents. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02318173.

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$a Gupta, Janesh $u Birmingham Women's and Children's Hospital, Birmingham, United Kingdom. Electronic address: J.K.GUPTA@bham.ac.uk.
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$a INTRODUCTION: To evaluate the effects of synthetic osmotic dilators (Dilapan-S/ Dilasoft) in women who required induction of labour in a large prospective multicentre international observational study. MATERIALS AND METHODS: Primary outcomes were duration of Dilapan-S/Dilasoft insertion (hours), total induction - delivery interval (hours) and the rate of vaginal deliveries within 24 h (%). Secondary outcomes were the number of dilators inserted, Bishop score increase after extraction of Dilapan-S/Dilasoft, complications during induction (uterine contractions, uterine tachysystole and hyperstimulation, effect on the fetus) and post induction (infections and neonatal outcomes), agents / procedures used for subsequent induction of labour, immediate rate of spontaneous labours following cervical ripening period, rate of spontaneous vaginal deliveries, rate of instrumental vaginal deliveries and caesarean sections. RESULTS: Total of 543 women were recruited across 11 study sites, of which, 444 women were eligible for analysis. With Dilapan-S/Dilasoft use of <12 h (n = 188) the overall vaginal delivery rate was 76.6% with 45.7% of these births occurring within 24 h, 66% within 36 h and 75.5% within 48 h from insertion of Dilapan-S/Dilasoft. The mean insertion-delivery interval for this group was 24.3(±10.4) hours. With Dilapan-S/Dilasoft use of >12 h (n = 256), the overall vaginal delivery rate was 64.8%, with 16% of these births occurring within 24 h, 48.4% within 36 h and 54.7% within 48 h from insertion of Dilapan-S/Dilasoft. The mean insertion-delivery interval for this group was 39.1(±29.2) hours. The mean gain in the Bishops score was +3.6(±2.3). The mean number of Dilapan-S/Dilasoft dilators used was 3.8 (±1.1). The overall rate of caesarean section was 30.1%. The overall complication rate was low including infection risk. No adverse neonatal outcome was attributable to the use of Dilapan-S/Dilasoft. CONCLUSION: Dilapan-S/Dilasoft are safe and effective methods for cervical ripening. Their use is associated with low maternal and neonatal complication rates. Future research should aim at level I clinical trials comparing Dilapan-S to other mechanical or pharmacological cervical ripening agents. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02318173.
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$a Chodankar, Rohan $u Royal Infirmary of Edinburgh, Scotland, United Kingdom. Electronic address: rohan.chodankar@nhs.net.
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$a Baev, Oleg $u National Medical Research Center of Obstetrics, Gynecology, and Perinatology named after Academician V.I. Kulakov, Ministry of Health of Russia, Moscow. Electronic address: metod_obsgyn@hotmail.com.
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$a Bahlmann, Franz $u Buerger Hospital, Frankfurt am Main, Germany. Electronic address: f.bahlmann@buergerhospital-ffm.de.
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$a Brega, Eugen $u National Medical Research Center of Obstetrics, Gynecology, and Perinatology named after Academician V.I. Kulakov, Ministry of Health of Russia, Moscow. Electronic address: evgeniy.brega@gmail.com.
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$a Gala, Anisha $u Fernandez Hospital, Hyderabad, Telangana, India. Electronic address: dranisha@fernandezhospital.com.
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$a Hellmeyer, Lars $u Vivantes Klinikum im Friedrichshain, Berlin, Germany. Electronic address: Lars.Hellmeyer@vivantes.de.
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$a Hruban, Lukas $u Masaryk University Hospital, Brno, Czech Republic. Electronic address: hruban.lukas@fnbrno.cz.
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$a Maier, Josefine $u Vivantes Klinikum im Friedrichshain, Berlin, Germany. Electronic address: josefine.maier@googlemail.com.
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$a Mehta, Priyanka $u Sri Ramachandra University, Chennai, India. Electronic address: priyankavimal6@gmail.com.
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$a Murthy, Amitasrigowri $u Bellevue Hospital, New York School of Medicine, New York, United States. Electronic address: amitasrigowrim@hotmail.com.
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$a Ritter, Melanie $u Buerger Hospital, Frankfurt am Main, Germany. Electronic address: mela.ritter@hotmail.de.
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$a Saad, Antonio $u University of Texas Medical Branch, Galveston, TX, United States. Electronic address: afsaad@UTMB.EDU.
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$a Shmakov, Roman $u National Medical Research Center of Obstetrics, Gynecology, and Perinatology named after Academician V.I. Kulakov, Ministry of Health of Russia, Moscow. Electronic address: mdshmakov@mail.ru.
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$a Suneja, Amita $u University College of Medical Sciences & Guru Teg Bahadur Hospital, New Delhi, Delhi, India. Electronic address: gynaeoffice@gmail.com.
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$a Zahumensky, Jozef $u Department of Gynecology and Obstetrics, Medical Faculty, Comenius University and University Hospital in Bratislava, Bratislava, Slovakia. Electronic address: zahumensky@ru.unb.sk.
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$a Gdovinova, Daniela $u Ex-Medicem International, Prague, Czech Republic. Electronic address: daniela.gdovinova@centrum.cz.
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