Dilapan-S/Dilasoft E-Registry in Induction of Labor (DSREGISTRYIL)

International Observational E-Registry on the Use of Dilapan-S / Dilasoft Osmotic Dilators for Cervical Ripening Prior to Labour Induction

International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.

Study Overview

• Status: Completed
• Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn; Labour Onset and Length Abnormalities
• Intervention / Treatment: Device: Dilapan-S

Detailed Description

International Observational E-Registry to monitor current common clinical practice of use of Dilapan-S / Dilasoft for cervical ripening and following procedures of labour induction with the main focus on the duration of induced labor procedure .

• Study Type: Observational
• Enrollment (Actual): 444

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 625 00
    • Masaryk University
• Germany
  • Berlin, Germany, 10249
    • Vivantes Klinikum im Friedrichshain
  • Frankfurt am Main, Germany, 60318
    • Buerger Hospital
• India
  • Delhi
    • New Delhi, Delhi, India, 110095
      • Guru Teg Bahadur Hospital
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600116
      • Sri Ramachandra Medical Center
  • Telangana
    • Hyderabad, Telangana, India, 500001
      • Fernandez Hospital
• Russian Federation
  • Moscow, Russian Federation, 117997
    • Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation
• Slovakia
  • Trnava, Slovakia, 917 75
    • University Hospital Trnava
• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2TG
      • Birmingham Women´s Hospital
• United States
  • New York
    • New York, New York, United States, 10016
      • Bellevue Hospital
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch Galveston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All the patients in whom the use of osmotic dilators Dilapan-S or Dilasoft is indicated by the Investigator after a thorough Medical examination will be included in the study unless that the patient disagree.

Description

Inclusion Criteria:

• Indication for induction of labor
• Unfavourable cervix

Exclusion Criteria:

• Presence of overt genital tract infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Dilapan-S/Dilasoft insertion	duration of cervical ripening	max. up to 24 hrs; estimated average 12 hrs)
Induction - delivery interval	Overall duration of induced labor procedure	estimated maximum up to 72 hrs
Rate of vaginal deliveries within 24 hours	Rate of vaginal deliveries achieved within 24 hours from the beginning of induced labor procedure	up to 24 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of osmotic dilator used: Dilapan-S or Dilasoft		up to 24 hrs; estimated average 12 hrs
Number of dilators inserted		up to 24 hrs; estimated average 12 hrs
Bishop Score increase after extraction of osmotic dilators		up to 24 hrs; estimated average 12 hrs
Complications during pre-induction	uterine contractions, uterine hypersensitivity, effect on the foetus	up to 24 hrs; estimated average 12 hrs
Agents / procedures used for induction of labour, if any	which, total dosage	estimated maximum up to 72 hrs
% of spontaneous vaginal deliveries following immediately after pre-induction		up to 24 hrs
% of total spontaneous vaginal deliveries		estimated maximum up to 72 hrs
% of instrumented vaginal deliveries		estimated maximum up to 72 hrs
% of Caesarean sections		estimated maximum up to 72 hrs
Foetal status	Apgar score at 0, 5 and 10 minutes after delivery, venous and arterial cord pH and base excess measurements	0, 5 and 10 minutes after delivery (estimated maximum up to 72 hrs)
Maternal infectious complication and its relation to the use of Dilapan-S/Dilasoft	Clinical signs of maternal infection found at patient´s examination are defined as follows: Body temperature > 37.8°C; Increased pain; Other overt clinical signs of infection e.g. vaginal dischargeLaboratory test results that need to be correlated with clinical signs of infection:; CRP levels > 8 mg/l; Leukocyte count > 18 x 109/l; Positive microbiological testing	up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.
Neonatal infectious complication and its relation to the use of Dilapan-S/Dilasoft	Clinical signs of neonatal infection found at patient´s examination are defined as follows: Body temperature > 37.8°C; Increased pain; Other overt clinical signs of infection e.g. vaginal dischargeLaboratory test results that need to be correlated with clinical signs of infection:; CRP levels > 8 mg/l; Leukocyte count > 18 x 109/l; Positive microbiological testing	up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.

Collaborators and Investigators

• Sponsor: Medicem International CR s.r.o.
• Investigators: Principal Investigator: Lars Hellmeyer, Doz, MD, Vivantes Klinikum im Friedrichshain, Berlin, Germany; Principal Investigator: Franz Bahlman, Doz, MD, Buerger Hospital, Frankfurt am Main, Germany; Study Chair: Janesh Gupta, MD, FRCOG, Birmingham Women´s Hospital, Birmingham, UK; Principal Investigator: Petr Janku, MD, Masaryk University Hospital, Brno, Czech Republic; Principal Investigator: Jozef Zahumensky, Doc, MD, University Hospital, Trnava, Slovakia; Principal Investigator: Oleg Baev, MD, PhD, Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation, Moscow, RUS; Principal Investigator: Antonio Saad, MD, PhD, University of Texas Medical Branch Galveston, TX, US; Principal Investigator: Amitasrigowri Murthy, MD, PhD, Bellevue Hospital, New York City, NY, US; Principal Investigator: Amita Suneja, Prof, MD, Guru Teg Bahadur Hospital, New Delhi, India; Principal Investigator: Usha Vishwanath, MD, Sri Ramachandra Medical Center, Chennai, India; Principal Investigator: Anisha Gala, MD, Fernandez Hospital, Hyderabad, India

Publications and helpful links

General Publications

• Sanchez-Ramos L. Induction of labor. Obstet Gynecol Clin North Am. 2005 Jun;32(2):181-200, viii. doi: 10.1016/j.ogc.2004.12.004.
• Tenore JL. Methods for cervical ripening and induction of labor. Am Fam Physician. 2003 May 15;67(10):2123-8.
• Ten Eikelder ML, Neervoort F, Oude Rengerink K, van Baaren GJ, Jozwiak M, de Leeuw JW, de Graaf I, van Pampus MG, Franssen M, Oudijk M, van der Salm P, Woiski M, Pernet PJ, Feitsma AH, van Vliet H, Porath M, Roumen F, van Beek E, Versendaal H, Heres M, Mol BW, Bloemenkamp KW. Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial. BMC Pregnancy Childbirth. 2013 Mar 19;13:67. doi: 10.1186/1471-2393-13-67. Erratum In: BMC Pregnancy Childbirth. 2013;13:183. van Baaren, Gert J [added].
• Jozwiak M, ten Eikelder M, Oude Rengerink K, de Groot C, Feitsma H, Spaanderman M, van Pampus M, de Leeuw JW, Mol BW, Bloemenkamp K; PROBAAT Study Group. Foley catheter versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and meta-analysis of literature. Am J Perinatol. 2014 Feb;31(2):145-56. doi: 10.1055/s-0033-1341573. Epub 2013 Apr 5.
• Sciscione AC, McCullough H, Manley JS, Shlossman PA, Pollock M, Colmorgen GH. A prospective, randomized comparison of Foley catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. Am J Obstet Gynecol. 1999 Jan;180(1 Pt 1):55-60. doi: 10.1016/s0002-9378(99)70149-3.
• Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.
• Suffecool K, Rosenn BM, Kam S, Mushi J, Foroutan J, Herrera K. Labor induction in nulliparous women with an unfavorable cervix: double balloon catheter versus dinoprostone. J Perinat Med. 2014 Mar;42(2):213-8. doi: 10.1515/jpm-2013-0152.
• Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. doi: 10.1097/00006254-200407000-00022.
• Chua S, Arulkumaran S, Vanaja K, Ratnam SS. Preinduction cervical ripening: prostaglandin E2 gel vs hygroscopic mechanical dilator. J Obstet Gynaecol Res. 1997 Apr;23(2):171-7. doi: 10.1111/j.1447-0756.1997.tb00828.x.
• 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. Synthetic osmotic dilators in the induction of labour-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:70-75. doi: 10.1016/j.ejogrb.2018.08.004. Epub 2018 Aug 3.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 17, 2014

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Cervical dilatation
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: DIS-2014-009