Dilapan-S/Dilasoft E-Registry in Induction of Labor

NCT02318173 | Completed

• 1 other identifier: DIS-2014-009
• Study Type: observational
• Target: 444
• Locations: 7 countries
• Sites: 11

Brief Summary

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

Conditions

Labour Onset and Length Abnormalities; Labor; Forced or Induced, Affecting Fetus or Newborn

Keywords

Cervical dilatation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• 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

  up to 24 hrs; estimated average 12 hrs

• Agents / procedures used for induction of labour, if any

  estimated maximum up to 72 hrs

Interventions

Dilapan-S DEVICE

Synthetic osmotic dilators Dilapan-S, Dilasoft for cervical ripening prior to induction of labor in women with unfavourable cervix

Also known as: Dilasoft

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Indication for induction of labor
• Unfavourable cervix

You may not qualify if:

• Presence of overt genital tract infection

Sponsors & Collaborators

• Medicem International CR s.r.o.: lead

Study Sites (11)

Bellevue Hospital

New York, New York, 10016, United States

Location

University of Texas Medical Branch Galveston

Galveston, Texas, 77555, United States

Location

Masaryk University

Brno, 625 00, Czechia

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Buerger Hospital

Frankfurt am Main, 60318, Germany

Location

Guru Teg Bahadur Hospital

New Delhi, National Capital Territory of Delhi, 110095, India

Location

Sri Ramachandra Medical Center

Chennai, Tamil Nadu, 600116, India

Location

Fernandez Hospital

Hyderabad, Telangana, 500001, India

Location

Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation

Moscow, 117997, Russia

Location

University Hospital Trnava

Trnava, 917 75, Slovakia

Location

Birmingham Women´s Hospital

Birmingham, West Midlands, B15 2TG, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 15899354 BACKGROUND

• Tenore JL. Methods for cervical ripening and induction of labor. Am Fam Physician. 2003 May 15;67(10):2123-8.

  PMID: 12776961 BACKGROUND

• 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.

  PMID: 23506128 BACKGROUND

• 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.

  PMID: 23564065 BACKGROUND

• 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.

  PMID: 9914578 BACKGROUND

• 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.

  PMID: 22704766 BACKGROUND

• 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.

  PMID: 24096438 BACKGROUND

• Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. doi: 10.1097/00006254-200407000-00022.

  PMID: 15199271 BACKGROUND

• 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.

  PMID: 9158305 BACKGROUND

• 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.

  PMID: 30107363 DERIVED

Study Officials

• Lars Hellmeyer, Doz, MD

  Vivantes Klinikum im Friedrichshain, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Franz Bahlman, Doz, MD

  Buerger Hospital, Frankfurt am Main, Germany

  PRINCIPAL INVESTIGATOR

• Janesh Gupta, MD, FRCOG

  Birmingham Women´s Hospital, Birmingham, UK

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 17, 2014
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 19, 2017

Record last verified: 2017-05

Locations

IN (3); SL (1); RU (1); CZ (1); DE (2); GB (1); US (2)