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Dilapan-S Osmotic Dilator in Pre-induction of Labor

NCT02098382 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2015-07-29

No results posted yet for this study

Summary

Non-interventional prospective data collection designed to evaluate clinical outcome on the efficacy of the use of Dilapan-S in the indication of labor pre-induction in women with/without a history of Caesarean section. The evaluation will be based on prospective data collection in at least four obstetrics centers in the Czech Republic.

Conditions

  • Uterine Cervical Incompetence

Interventions

DEVICE

Dilapan-S

Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction

Sponsors & Collaborators

  • Medicem International CR s.r.o.

    lead INDUSTRY

Principal Investigators

  • Ondrej Simetka, AssProf,PhD · Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic

  • Lukas Hruban, M.D. · Clinic of gynecology and obstetrics, University hospital of Brno, Czech Republic

  • Igor Michalec, M.D. · Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic

  • Radovan Vlk, M.D. · Clinic of gynecology and obstetrics, University hospital of II. Medicine college of Charles University in Prague, Czech Republic

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-10-31
Completion
2014-10-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02098382 on ClinicalTrials.gov