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

Janesh Gupta, Rohan Chodankar, Oleg Baev, Franz Bahlmann, Eugen Brega, Anisha Gala, Lars Hellmeyer, Lukas Hruban, Josefine Maier, Priyanka Mehta, Amitasrigowri Murthy, Melanie Ritter, Antonio Saad, Roman Shmakov, Amita Suneja, Jozef Zahumensky, Daniela Gdovinova

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)70-75
Number of pages6
JournalEuropean Journal of Obstetrics Gynecology and Reproductive Biology
Volume229
DOIs
StatePublished - Oct 1 2018

Fingerprint

Multicenter Studies
Observational Studies
Cervical Ripening
Induced Labor
Cesarean Section
Clinical Trials
dilapan
Uterine Contraction
Infection
Fetus
Mothers
Parturition
Pharmacology

Keywords

  • Birth
  • Cervical ripening
  • Dilapan-S
  • Induction of labour
  • Pregnancy
  • Synthetic osmotic dilators

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Synthetic osmotic dilators in the induction of labour—An international multicentre observational study. / Gupta, Janesh; Chodankar, Rohan; Baev, Oleg; Bahlmann, Franz; Brega, Eugen; Gala, Anisha; Hellmeyer, Lars; Hruban, Lukas; Maier, Josefine; Mehta, Priyanka; Murthy, Amitasrigowri; Ritter, Melanie; Saad, Antonio; Shmakov, Roman; Suneja, Amita; Zahumensky, Jozef; Gdovinova, Daniela.

In: European Journal of Obstetrics Gynecology and Reproductive Biology, Vol. 229, 01.10.2018, p. 70-75.

Research output: Contribution to journalArticle

Gupta, J, Chodankar, R, Baev, O, Bahlmann, F, Brega, E, Gala, A, Hellmeyer, L, Hruban, L, Maier, J, Mehta, P, Murthy, A, Ritter, M, Saad, A, Shmakov, R, Suneja, A, Zahumensky, J & Gdovinova, D 2018, 'Synthetic osmotic dilators in the induction of labour—An international multicentre observational study', European Journal of Obstetrics Gynecology and Reproductive Biology, vol. 229, pp. 70-75. https://doi.org/10.1016/j.ejogrb.2018.08.004
Gupta, Janesh ; Chodankar, Rohan ; Baev, Oleg ; Bahlmann, Franz ; Brega, Eugen ; Gala, Anisha ; Hellmeyer, Lars ; Hruban, Lukas ; Maier, Josefine ; Mehta, Priyanka ; Murthy, Amitasrigowri ; Ritter, Melanie ; Saad, Antonio ; Shmakov, Roman ; Suneja, Amita ; Zahumensky, Jozef ; Gdovinova, Daniela. / Synthetic osmotic dilators in the induction of labour—An international multicentre observational study. In: European Journal of Obstetrics Gynecology and Reproductive Biology. 2018 ; Vol. 229. pp. 70-75.
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abstract = "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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T1 - Synthetic osmotic dilators in the induction of labour—An international multicentre observational study

AU - Gupta, Janesh

AU - Chodankar, Rohan

AU - Baev, Oleg

AU - Bahlmann, Franz

AU - Brega, Eugen

AU - Gala, Anisha

AU - Hellmeyer, Lars

AU - Hruban, Lukas

AU - Maier, Josefine

AU - Mehta, Priyanka

AU - Murthy, Amitasrigowri

AU - Ritter, Melanie

AU - Saad, Antonio

AU - Shmakov, Roman

AU - Suneja, Amita

AU - Zahumensky, Jozef

AU - Gdovinova, Daniela

PY - 2018/10/1

Y1 - 2018/10/1

N2 - 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.

AB - 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.

KW - Birth

KW - Cervical ripening

KW - Dilapan-S

KW - Induction of labour

KW - Pregnancy

KW - Synthetic osmotic dilators

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