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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 is a NA study of Failed Labour that has completed, run by University of South Carolina. The registered enrollment target is 102 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01390233
The ClinicalTrials.gov registry entry for NCT01390233 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Carolina, which has 157 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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