Trial · NCT03806231
A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening
NCT03806231, Phase 3, Terminated, Intermountain Health Care, Inc.; results first posted 2021-09-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening. Trials, record NCT03806231. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03806231
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening
- NCT number
- NCT03806231
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 8 participants, actual
- Lead sponsor
- Intermountain Health Care, Inc.
- Conditions
- Induction of Labor Affected Fetus / Newborn
- Interventions
- Outpatient Dinoprostone 10mg, Inpatient Dinoprostone 10 mg
- First posted
- 2019-01-16
- Last updated
- 2021-09-05
- Results first posted
- 2021-09-05
- Limitations and caveats
- Trial terminated prior to meeting sufficient sample size for outcome analyses.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dilation Completion Time | Time of admission to completion of dilation (up to 48 hours) | Time of admission for induction to complete dilation. |
| Primary | Total Cost of Induction Charged to Patient | Through study completion (up to 1 year) | Total hospital charges to patient, as obtained by Intermountain Healthcare billing |
| Secondary | Patient Satisfaction: Survey | Time of delivery to discharge (up to 96 hours) | Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls. |
| Secondary | Vaginal Delivery Rate | Through study completion (up to 1 year) | Number of patients enrolled who delivered vaginally |
| Secondary | Operative Vaginal Delivery Rate | Through study completion (up to 1 year) | Number of patients enrolled who required an operative vaginal delivery |
| Secondary | Cesarean Delivery Rate | Through study completion (up to 1 year) | Number of patients enrolled who had a c-section delivery |
| Secondary | Start of Oxytocin Until Delivery | Time oxytocin is administered to time of delivery (up to 24 hours) | Length of time between patient receiving oxytocin and delivery |
| Secondary | Time of Delivery Until Discharge | Time of delivery to discharge (up to 96 hours) | Length of time between delivery and discharge. |
| Secondary | Time of Admission Until Discharge | Time of admission to labor and delivery to discharge (up to 96 hours) | Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge |
| Other | Infant 5 Minute APGAR Score | From delivery to 5 minutes following delivery | APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dilation Completion Time | Time of admission to completion of dilation (up to 48 hours) | Trial terminated prior to meeting sufficient sample size for analysis. | ||
| PRIMARY | Total Cost of Induction Charged to Patient | Through study completion (up to 1 year) | Trial terminated prior to meeting sample size for sufficient analysis. | ||
| SECONDARY | Patient Satisfaction: Survey | Time of delivery to discharge (up to 96 hours) | Trial terminated prior to meeting sufficient sample size for analysis. | ||
| SECONDARY | Vaginal Delivery Rate | Through study completion (up to 1 year) | Trial terminated prior to meeting sufficient sample size for analysis. | ||
| SECONDARY | Operative Vaginal Delivery Rate | Through study completion (up to 1 year) | Trial terminated prior to meeting sufficient sample size for analysis. | ||
| SECONDARY | Cesarean Delivery Rate | Through study completion (up to 1 year) | Trial terminated prior to meeting sufficient sample size for analysis. | ||
| SECONDARY | Start of Oxytocin Until Delivery | Time oxytocin is administered to time of delivery (up to 24 hours) | Trial terminated prior to meeting sufficient sample size for analysis. | ||
| SECONDARY | Time of Delivery Until Discharge | Time of delivery to discharge (up to 96 hours) | Trial terminated prior to meeting sufficient sample size for analysis. | ||
| SECONDARY | Time of Admission Until Discharge | Time of admission to labor and delivery to discharge (up to 96 hours) | Trial terminated prior to meeting sufficient sample size for analysis. | ||
| OTHER_PRE_SPECIFIED | Infant 5 Minute APGAR Score | From delivery to 5 minutes following delivery | Trial terminated prior to meeting sufficient sample size for analysis. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Outpatient Cervical Ripening | 4 | |
| Overall Study | STARTED | Inpatient Cervical Ripening | 4 | |
| Overall Study | COMPLETED | Outpatient Cervical Ripening | 2 | |
| Overall Study | COMPLETED | Inpatient Cervical Ripening | 4 | |
| Overall Study | NOT COMPLETED | Outpatient Cervical Ripening | 2 | |
| Overall Study | NOT COMPLETED | Inpatient Cervical Ripening | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Non-Serious Adverse Event | Pregnancy, puerperium and perinatal conditions | Outpatient Cervical Ripening | 0 | 4 | 0 |
| other | Non-Serious Adverse Event | Pregnancy, puerperium and perinatal conditions | Inpatient Cervical Ripening | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Outpatient Cervical Ripening | 0 | 4 |
| Total, all-cause mortality | Inpatient Cervical Ripening | 0 | 4 |
| Total, other adverse events | Outpatient Cervical Ripening | 0 | 4 |
| Total, other adverse events | Inpatient Cervical Ripening | 1 | 4 |
| Total, serious adverse events | Outpatient Cervical Ripening | 0 | 4 |
| Total, serious adverse events | Inpatient Cervical Ripening | 0 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32852803 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Outpatient Cervical Ripening vs Inpatient Cervical Ripening: deaths from any cause | Trial comparisons |
| Outpatient Cervical Ripening vs Inpatient Cervical Ripening: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03806231
GET https://conductscience.org/api/trials/v1/NCT03806231/registered