Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01390233 · ClinicalTrials.gov registry record · NA
Comparison of Pre-Induction Cervical Ripening
A NA study of Failed Labour, sponsored by University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT01390233: Completed NA study of Failed Labour, sponsored by University of South Carolina.
NCT01390233 is a NA study of Failed Labour that has completed, run by University of South Carolina. The registered enrollment target is 102 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01390233, a NA study of Failed Labour, has completed, sponsored by University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel. The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising. This has led to a renewed effort to examine the effectiveness of the varied methods of induction. The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial. Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The investigator will be given the next sequentially numbered study randomization envelope by the patient's nurse. The randomization assignment will be unblinded to the patient and her physicians. If the patient is not in active labor 6 hours after initiation of the intervention, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Prepidil Gel
- DEVICE Urinary Balloon Catheter
- OTHER Combined Urinary Catheter & Prepidil Gel
Study Locations (1)
South Carolina
- Palmetto Health Richland Hospital - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-05 |
| Phase | NA |
What the finished NCT01390233 record still lists
NCT01390233 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Failed Labour appearing as the primary indexed condition, and to 3 interventions - of which Prepidil Gel is the first listed.
NCT01390233 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT01390233 about?
NCT01390233 is a clinical study titled "Comparison of Pre-Induction Cervical Ripening". This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel. The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the freq...
What is the current status of trial NCT01390233?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2010-07. Estimated completion is 2013-05.
What conditions does trial NCT01390233 study?
This clinical trial studies the following conditions: Failed Labour.
What interventions are being tested in trial NCT01390233?
The interventions under investigation include: Prepidil Gel (DRUG), Urinary Balloon Catheter (DEVICE), Combined Urinary Catheter & Prepidil Gel (OTHER).
Who is sponsoring clinical trial NCT01390233?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01390233 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01390233's enrollment target sits among peer trials
102 837th of 2000 higher than 1,161 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03704662 · 102 participants · NA
Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
- NCT04174742 · 102 participants
Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
- NCT04275362 · 102 participants
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
- NCT04541082 · 102 participants · Phase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia