Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
444 participants
OBSERVATIONAL
2015-05-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Dilapan-S
Synthetic osmotic dilators Dilapan-S, Dilasoft for cervical ripening prior to induction of labor in women with unfavourable cervix
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unfavourable cervix
Exclusion Criteria
FEMALE
No
Sponsors
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Medicem International CR s.r.o.
INDUSTRY
Responsible Party
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Principal Investigators
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Lars Hellmeyer, Doz, MD
Role: PRINCIPAL_INVESTIGATOR
Vivantes Klinikum im Friedrichshain, Berlin, Germany
Franz Bahlman, Doz, MD
Role: PRINCIPAL_INVESTIGATOR
Buerger Hospital, Frankfurt am Main, Germany
Janesh Gupta, MD, FRCOG
Role: STUDY_CHAIR
Birmingham Women´s Hospital, Birmingham, UK
Petr Janku, MD
Role: PRINCIPAL_INVESTIGATOR
Masaryk University Hospital, Brno, Czech Republic
Jozef Zahumensky, Doc, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Trnava, Slovakia
Oleg Baev, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation, Moscow, RUS
Antonio Saad, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Medical Branch Galveston, TX, US
Amitasrigowri Murthy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Bellevue Hospital, New York City, NY, US
Amita Suneja, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Guru Teg Bahadur Hospital, New Delhi, India
Usha Vishwanath, MD
Role: PRINCIPAL_INVESTIGATOR
Sri Ramachandra Medical Center, Chennai, India
Anisha Gala, MD
Role: PRINCIPAL_INVESTIGATOR
Fernandez Hospital, Hyderabad, India
Locations
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Bellevue Hospital
New York, New York, United States
University of Texas Medical Branch Galveston
Galveston, Texas, United States
Masaryk University
Brno, , Czechia
Vivantes Klinikum im Friedrichshain
Berlin, , Germany
Buerger Hospital
Frankfurt am Main, , Germany
Guru Teg Bahadur Hospital
New Delhi, National Capital Territory of Delhi, India
Sri Ramachandra Medical Center
Chennai, Tamil Nadu, India
Fernandez Hospital
Hyderabad, Telangana, India
Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation
Moscow, , Russia
University Hospital Trnava
Trnava, , Slovakia
Birmingham Women´s Hospital
Birmingham, West Midlands, United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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DIS-2014-009
Identifier Type: -
Identifier Source: org_study_id
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