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Dilapan-S®: A Multicenter US E-registry

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 22, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Study completion date: Dec 31, 2024 to Jun 30, 2025
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Enrollment target: 500 to 1200
    • Primary completion date: Dec 31, 2021 to Dec 31, 2024
    • Study completion date: Aug 1, 2022 to Dec 31, 2024
    v3
  4. Primary completion date changed from estimate of Dec 30, 2020 to Dec 31, 2021
    • Start date changed from estimate of Aug 1, 2020 to Dec 1, 2020
    • Study completion date: Dec 30, 2020 to Aug 1, 2022
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 registry, relevant collected data will be analyzed and published.
Trial Details
NCT Number NCT04451109
Lead Sponsor Medicem Technology s.r.o.
Collaborators: The University of Texas Medical Branch, Galveston
Conditions
(from sponsor)		 Post Term Pregnancy, Premature Rupture of Membrane, Fetal Growth Retardation, Oligohydramnios, Gestational Diabetes, High Blood Pressure in Pregnancy
Related terms Diabetes, Gestational, Fetal Growth Retardation, Oligohydramnios, Pregnancy, Prolonged, Premature Rupture of Fetal Membranes
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov