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

Authors

GUPTA Janesh CHODANKAR Rohan BAEV Oleg BAHLMANN Franz BREGA Eugen GALA Anisha HELLMEYER Lars HRUBAN Lukáš MAIER Josefine MEHTA Priyanka MURTHY Amitasrigowri RITTER Melanie SAAD Antonio SHMAKOV Roman SUNEJA Amita ZAHUMENSKY Jozef GDOVINOVA Daniela

Year of publication 2018
Type Article in Periodical
Magazine / Source EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY
MU Faculty or unit

Faculty of Medicine

Citation
Doi http://dx.doi.org/10.1016/j.ejogrb.2018.08.004
Keywords Cervical ripening; Dilapan-S; Induction of labour; Synthetic osmotic dilators; Pregnancy; Birth
Description 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 24h (%). 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/Dilaso 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 clinical trials comparing Dilapan-S to other mechanical or pharmacological cervical ripening agents. (C) 2018 Elsevier B.V. All rights reserved.

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