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Dilapan-S®: A Multicenter US E-registry

NCT04451109 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2024-11-22

No results posted yet for this study

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 registry, relevant collected data will be analyzed and published.

Conditions

  • Post Term Pregnancy
  • Premature Rupture of Membrane
  • Fetal Growth Retardation
  • Oligohydramnios
  • Gestational Diabetes
  • High Blood Pressure in Pregnancy

Interventions

DEVICE

Dilapan-S

Application of Dilapan-S and all other procedures regarding cervical ripening and induction of labor will be carried out as per the hospital's standard practice.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    collaborator OTHER

  • Medicem Technology s.r.o.

    lead OTHER

Principal Investigators

  • Antonio Saad, MD · The University of Texas Medical Branch, Galveston

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-12-31
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States

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 NCT04451109 on ClinicalTrials.gov