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Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®

NCT03665688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2023-07-27

Study results available
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Summary

The target population for our study is women who present for induction of labor. If there is a decision by the obstetrical team to place a mechanical dilator for cervical ripening, the obstetrical team will notify the research staff so that the patient may be screened for the study. If the subject is eligible for the trial, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the informed consent procedure. After informed consent is obtained and Dilapan-S is placed, the patient will be randomized to the Outpatient or the Inpatient group.

Conditions

  • Labor, Induced
  • Cervix Uteri-Diseases

Interventions

DEVICE

Outpatient Dilapan-S

After Dilapan-S placement, subjects will be given the option to either return home or to stay in a hotel if transportation is an issue. Subjects will also be instructed to return to L\&D unit 12 hours after insertion, or earlier if any excessive bleeding, rupture of membranes, pain or other concerns (contractions, decreased fetal movement) develop before the 12 hours. After the designated 12 hours' time or earlier, if indicated, subjects are to return and to be admitted to L\&D unit for standard protocol of labor induction.

DEVICE

Inpatient Dilapan-S

After Dilapan-S placement, subjects will be admitted to L\&D unit and standard clinical protocol will be initiated for cervical ripening and labor induction. During the period of 12 hours of cervical ripening subject is to remain "nothing per os" (NPO), "nothing per vagina" and undergo continuous fetal heart rate monitoring. No other interventions are to occur during this period of 12 hours, unless clinically indicated.

Sponsors & Collaborators

  • Medicem International CR s.r.o.

    collaborator INDUSTRY

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2021-11-05
Completion
2021-11-05
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 NCT03665688 on ClinicalTrials.gov