Trial · NCT01390233
Comparison of Pre-Induction Cervical Ripening
NCT01390233, Not applicable, Completed, University of South Carolina; results first posted 2014-05-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Pre-Induction Cervical Ripening. Trials, record NCT01390233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01390233
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Pre-Induction Cervical Ripening
- NCT number
- NCT01390233
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 102 participants, actual
- Lead sponsor
- University of South Carolina
- Conditions
- Failed Labour
- Interventions
- Prepidil Gel, Urinary Balloon Catheter, Combined Urinary Catheter & Prepidil Gel
- First posted
- 2011-07-08
- Last updated
- 2014-05-30
- Results first posted
- 2014-05-30
- Limitations and caveats
Limits included: patients enrolled who did not meet inclusion criteria (Bishop score too favorable, but recruited by clinician), patients who were enrolled but catheter could not be placed, patient enrolled who ultimately decided to undergo cesarean.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vaginal Delivery | Gestational age 26-42 weeks | The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Vaginal Delivery | Gestational age 26-42 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Vaginal Delivery | Urinary Balloon Catheter Only | 20 | participants | ||
| Vaginal Delivery | Prepadil Only | 21 | participants | ||
| Vaginal Delivery | Combined Urinary Catheter & Prepadil Gel | 20 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Urinary Balloon Catheter Only | 35 | |
| Overall Study | STARTED | Prepadil Only | 31 | |
| Overall Study | STARTED | Combined Urinary Catheter & Prepadil Gel | 36 | |
| Overall Study | COMPLETED | Urinary Balloon Catheter Only | 30 | |
| Overall Study | COMPLETED | Prepadil Only | 29 | |
| Overall Study | COMPLETED | Combined Urinary Catheter & Prepadil Gel | 30 | |
| Overall Study | NOT COMPLETED | Urinary Balloon Catheter Only | 5 | |
| Overall Study | NOT COMPLETED | Prepadil Only | 2 | |
| Overall Study | NOT COMPLETED | Combined Urinary Catheter & Prepadil Gel | 6 |
Source ClinicalTrials.gov
Adverse events3
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 |
|---|---|---|---|---|---|---|
| serious | Placental Abruption | Pregnancy, puerperium and perinatal conditions | Urinary Balloon Catheter Only | 0 | 35 | 0 |
| serious | Placental Abruption | Pregnancy, puerperium and perinatal conditions | Prepadil Only | 0 | 31 | 0 |
| serious | Placental Abruption | Pregnancy, puerperium and perinatal conditions | Combined Urinary Catheter & Prepadil Gel | 1 | 36 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Urinary Balloon Catheter Only | ||
| Total, all-cause mortality | Prepadil Only | ||
| Total, all-cause mortality | Combined Urinary Catheter & Prepadil Gel | ||
| Total, other adverse events | Urinary Balloon Catheter Only | 0 | 35 |
| Total, other adverse events | Prepadil Only | 0 | 31 |
| Total, other adverse events | Combined Urinary Catheter & Prepadil Gel | 0 | 36 |
| Total, serious adverse events | Urinary Balloon Catheter Only | 0 | 35 |
| Total, serious adverse events | Prepadil Only | 0 | 31 |
| Total, serious adverse events | Combined Urinary Catheter & Prepadil Gel | 1 | 36 |
Source ClinicalTrials.gov
Papers32
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01390233
GET https://conductscience.org/api/trials/v1/NCT01390233/papers?page=2