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NCT02975167 · ClinicalTrials.gov registry record · NA
Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor
A NA study of Patient Satisfaction and Cervical Ripening, sponsored by MemorialCare Health System.
- Completed
- Registry status
- NA
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT02975167: Completed NA study of Patient Satisfaction and Cervical Ripening, sponsored by MemorialCare Health System.
NCT02975167 is a NA study of Patient Satisfaction and Cervical Ripening that has completed, run by MemorialCare Health System. The registered enrollment target is 94 participants, below the 463-participant average among 20 other Patient Satisfaction trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02975167, a NA study of Patient Satisfaction and Cervical Ripening, has completed, sponsored by MemorialCare Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 94 participants
- Enrollment target
- 1
- Study location
Study Summary
Labor induction is one of the most common obstetric procedures performed in the U.S. In 2012, the last year for which data is available, 23.7% of all deliveries were the result of inductions. Labor induction first requires cervical ripening, which can be accomplished by several different methods. Vaginal or oral prostaglandins, extra amniotic saline infusion, osmotic dilators and transcervical Foley catheters are all widely used instruments for pre-induction cervical ripening. The ideal cervical ripening tool is safe for both mother and fetus, incurs low cost, does not require extensive monitoring, and causes minimal maternal discomfort. The Foley catheter has been found to be both safe and effective, but little is known about patient satisfaction with the device in an in-patient and out-patient setting. The proposed study will investigate patient satisfaction in a randomized controlled trial of in-patient versus out-patient use of Foley catheters.
Primary Outcome
The primary outcome will be the total score on Part A of the survey, giving an overall rating of the patients' experience with treatment. Means and standard deviations of the total score will be calculated and reported by treatment group among nulliparous and multiparous patients separately. To address the main hypothesis, an ANOVA (analysis-of-variance) will be performed on an intention-to-treat basis and the stratum (nulliparous vs multiparous) will be controlled for in the analysis. The mean
Conditions Studied
Interventions
- OTHER Outpatient Cervical Ripening
- OTHER Inpatient Cervical Ripening
- PROCEDURE Foley catheter placement
- BEHAVIORAL Pre-Foley Questionnaire
- BEHAVIORAL Post-Foley Questionnaire
Study Locations (1)
California
- Miller Women's and Children's Hospital Long Beach - Long Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2016-11 |
| Est. Completion | 2025-01-29 |
| Phase | NA |
What the finished NCT02975167 record still lists
NCT02975167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 463-participant average among 20 other Patient Satisfaction trials with a reported enrollment target (80% lower).
The record links to 3 conditions, with Patient Satisfaction appearing as the primary indexed condition, and to 5 interventions - of which Outpatient Cervical Ripening is the first listed.
NCT02975167 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02975167 about?
NCT02975167 is a clinical study titled "Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor". Labor induction is one of the most common obstetric procedures performed in the U.S. In 2012, the last year for which data is available, 23.7% of all deliveries were the result of inductions. Labor induction first requires cervical ripening, which can be accomplished by several different methods. Va...
What is the current status of trial NCT02975167?
This trial is currently completed. It is a NA study. The enrollment target is 94 participants. The study started on 2016-11. Estimated completion is 2025-01-29.
What conditions does trial NCT02975167 study?
This clinical trial studies the following conditions: Patient Satisfaction, Cervical Ripening, Induction of Labor Affected Fetus / Newborn.
What interventions are being tested in trial NCT02975167?
The interventions under investigation include: Outpatient Cervical Ripening (OTHER), Inpatient Cervical Ripening (OTHER), Foley catheter placement (PROCEDURE), Pre-Foley Questionnaire (BEHAVIORAL), Post-Foley Questionnaire (BEHAVIORAL).
Who is sponsoring clinical trial NCT02975167?
This trial is sponsored by MemorialCare Health System, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02975167 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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