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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
125 participants
OBSERVATIONAL
2013-05-31
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dilapan-S/Dilasoft E-Registry in Induction of Labor
NCT02318173
Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®
NCT03665688
Comparison Between Two Medical Devices for Labor Induction After Previous C-section
NCT06506721
An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt
NCT03001661
Dilapan-S® for Induction of Labor The Feasibility Study
NCT04521062
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dilapan-S
125 Patients with / without caesarean section in their medical history
Dilapan-S
Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dilapan-S
Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pregnancy more than 36 weeks
* Vertex presentation of the fetus
* Cervix Score less than 4 points
Exclusion Criteria
* Pathological fetal station
* States after uterine body surgery - except for Caesarean section
* Clinical signs of uterine, vaginal or vulvar infection
* Fetus hypoxia (KTG recording evaluated as pathological prior to pre-induction initiation)
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medicem International CR s.r.o.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ondrej Simetka, AssProf,PhD
Role: PRINCIPAL_INVESTIGATOR
Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic
Lukas Hruban, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinic of gynecology and obstetrics, University hospital of Brno, Czech Republic
Igor Michalec, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic
Radovan Vlk, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinic of gynecology and obstetrics, University hospital of II. Medicine college of Charles University in Prague, Czech Republic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinic of Gynecology&Obstetrics, University hospital in Brno and Masaryk University Medical School
Brno, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Serhal P, Ranieri DM, Khadum I, Wakim RA. Cervical dilatation with hygroscopic rods prior to ovarian stimulation facilitates embryo transfer. Hum Reprod. 2003 Dec;18(12):2618-20. doi: 10.1093/humrep/deg477.
Chen FC, Bergann A, Krosse J, Merholz A, David M. Isosorbide mononitrate vaginal gel versus misoprostol vaginal gel versus Dilapan-S for cervical ripening before first trimester curettage. Eur J Obstet Gynecol Reprod Biol. 2008 Jun;138(2):176-9. doi: 10.1016/j.ejogrb.2007.09.009. Epub 2007 Nov 5.
Allen RH, Goldberg AB; Board of Society of Family Planning. Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation). SFP Guideline 20071. Contraception. 2007 Aug;76(2):139-56. doi: 10.1016/j.contraception.2007.05.001. Epub 2007 Jul 10.
Samuel MI, Parsons JH. Hygroscopic dilator (Dilapan-S) and misoprostol combination for the early first-trimester termination of pregnancy: a pilot study. J Fam Plann Reprod Health Care. 2009 Jan;35(1):45-7. doi: 10.1783/147118909787072234.
Wilson LC, Meyn LA, Creinin MD. Cervical preparation for surgical abortion between 12 and 18 weeks of gestation using vaginal misoprostol and Dilapan-S. Contraception. 2011 Jun;83(6):511-6. doi: 10.1016/j.contraception.2010.10.004. Epub 2010 Dec 3.
Chambers DG, Willcourt RJ, Laver AR, Baird JK, Herbert WY. Comparison of Dilapan-S and laminaria for cervical priming before surgical pregnancy termination at 17-22 weeks' gestation. Int J Womens Health. 2011;3:347-52. doi: 10.2147/IJWH.S25551. Epub 2011 Oct 20.
Lyus R, Lohr PA, Taylor J, Morroni C. Outcomes with same-day cervical preparation with Dilapan-S osmotic dilators and vaginal misoprostol before dilatation and evacuation at 18 to 21+6 weeks' gestation. Contraception. 2013 Jan;87(1):71-5. doi: 10.1016/j.contraception.2012.07.006. Epub 2012 Aug 13.
Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11.
Bartz D, Maurer R, Allen RH, Fortin J, Kuang B, Goldberg AB. Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):57-63. doi: 10.1097/AOG.0b013e3182983889.
Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.
Borgatta L, Lopatinsky I, Shaw FM. Overcoming unsatisfactory colposcopy. Use of osmotic dilators. J Reprod Med. 1997 May;42(5):271-5.
Newmann SJ, Sokoloff A, Tharyil M, Illangasekare T, Steinauer JE, Drey EA. Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):271-278. doi: 10.1097/AOG.0000000000000080.
Roztocil A, Pilka L, Jelinek J, Koudelka M, Miklica J. A comparison of three preinduction cervical priming methods: prostaglandin E2 gel, Dilapan S rods and Estradiol gel. Ceska Gynekol. 1998 Feb;63(1):3-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DIS2013-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.