Status:
ACTIVE_NOT_RECRUITING
Dilapan-S®: A Multicenter US E-registry
Lead Sponsor:
Medicem Technology s.r.o.
Collaborating Sponsors:
The University of Texas Medical Branch, Galveston
Conditions:
Post Term Pregnancy
Premature Rupture of Membrane
Eligibility:
FEMALE
18+ years
Brief Summary
Objective of this registry is to collect a representative set of real world data on the use of Dilapan-S® for pre-induction cervical ripening in daily clinical practice. Upon completion of the registr...
Detailed Description
In the US, 23% of pregnant women undergo labor induction. A recent randomized controlled trial showed that elective labor induction at term in low-risk nulliparous women is associated with a lower ris...
Eligibility Criteria
Inclusion
- Pregnant woman whose plan of care is induction of labor
- Maternal age ≥ 18 years
- Gestational age ≥ 37 +0/7 weeks
- Dilapan-S® used for cervical ripening
Exclusion
- Data not available for extraction
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04451109
Start Date
December 1 2020
End Date
June 30 2025
Last Update
November 22 2024
Active Locations (1)
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1
The University of Texas Medical Branch
Galveston, Texas, United States, 77555