Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03806231 · ClinicalTrials.gov registry record · Phase 3
A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening
A Phase 3 study, sponsored by Intermountain Health Care.
- Terminated
- Registry status
- Phase 3
- Development phase
- 8
- Enrollment target
NCT03806231 is a Phase 3 study that was terminated before completion, run by Intermountain Health Care. The registered enrollment target is 8 participants.
The verdict
NCT03806231, a Phase 3 study, was terminated before completion, sponsored by Intermountain Health Care.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 8 participants
- Enrollment target
Study Summary
Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score \<6) increases the risk of cesarean section. This risk may be reduced by ripening or softening the cervix before the induction of labor. This protocol outlines a randomized trial of 200 women evaluating the placement and use of Cervidil to the post vaginal fornix to soften the cervix in preparation for induction. This trial is looking at inpatient vs outpatient pre-induction cervical ripening using Cervidil and the effects on (1) maternal and newborn outcomes including time of admission to delivery, (2) system healthcare cost, (3) cost to patient, and (4) patient satisfaction. The investigators hypothesize when compared to patients admitted to the hospital for cervical ripening: 1. From the time of admission, patients in the outpatient cervical ripening arm will progress to complete cervical dilation in less time. 2. The total overall cost of care for the encounter will be reduced for the group in the outpatient cervical ripening arm. 3. Patients in the outpatient cervical ripening arm will have more overall satisfaction.
Interventions
- DRUG Outpatient Dinoprostone 10mg
- DRUG Inpatient Dinoprostone 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-08-07 |
| Est. Completion | 2020-04-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03806231
The ClinicalTrials.gov registry entry for NCT03806231 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intermountain Health Care, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Outpatient Dinoprostone 10mg is the first listed.
NCT03806231 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03806231 about?
NCT03806231 is a clinical study titled "A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening". Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score \<6) increases the risk of cesarean section. This risk may be reduced by ripening or softening the cervix before the induction of labor. This protocol outlines a randomized tr...
What is the current status of trial NCT03806231?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 8 participants. The study started on 2019-08-07. Estimated completion is 2020-04-11.
What interventions are being tested in trial NCT03806231?
The interventions under investigation include: Outpatient Dinoprostone 10mg (DRUG), Inpatient Dinoprostone 10 mg (DRUG).
Who is sponsoring clinical trial NCT03806231?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.