Dilapan-S Osmotic Dilator in Pre-induction of Labor
Launched by MEDICEM INTERNATIONAL CR S.R.O. · Mar 24, 2014
Trial Information
Current as of June 10, 2025
Completed
Keywords
ClinConnect Summary
Nowadays there is a rising need for non-pharmacological cervical ripening methods as the use of prostaglandins is frequently limited by various contraindications. Dilapan-S is a hygroscopic uterine neck dilator. Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of Dilapan-S sticks which subsequently exert radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results not only in its mechanical dilatation but pressure on...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Single pregnancy
- • Pregnancy more than 36 weeks
- • Vertex presentation of the fetus
- • Cervix Score less than 4 points
- Exclusion Criteria:
- • Contraindication to vaginal delivery
- • 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)
About Medicem International Cr S.R.O.
Medicem International CR s.r.o. is a leading clinical trial sponsor specializing in the development and management of innovative therapies across various therapeutic areas. With a commitment to advancing healthcare through rigorous scientific research, Medicem International CR s.r.o. collaborates with healthcare professionals and regulatory bodies to ensure the highest standards of patient safety and data integrity. The organization leverages its extensive expertise in clinical operations and regulatory compliance to facilitate the efficient conduct of clinical trials, ultimately aiming to bring novel treatments to market that improve patient outcomes and enhance the quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brno, , Czech Republic
Patients applied
Trial Officials
Ondrej Simetka, AssProf,PhD
Principal Investigator
Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic
Lukas Hruban, M.D.
Principal Investigator
Clinic of gynecology and obstetrics, University hospital of Brno, Czech Republic
Igor Michalec, M.D.
Principal Investigator
Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic
Radovan Vlk, M.D.
Principal Investigator
Clinic of gynecology and obstetrics, University hospital of II. Medicine college of Charles University in Prague, Czech Republic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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