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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: Clinical Trial Phase 3 study, sponsored by Intermountain Health Care.
NCT03806231 is a Phase 3 study that was terminated before completion, run by Intermountain Health Care. The registered enrollment target is 8 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time of admission for induction to complete dilation.
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 |
Why NCT03806231 stopped before completion
NCT03806231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Outpatient Dinoprostone 10mg is the first listed.
NCT03806231 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03806231's enrollment target sits among peer trials
8 1993rd of 2000 higher than 6 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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