N/A
N=100
Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening
Cervical Ripening · Induction of Labor
Bottom Line
View on ClinicalTrials.gov: NCT03111316 ↗Enrolled (actual)
100
Serious AEs
5.0%
Results posted
May 2019
Primary outcome: Primary: The Median Times From Placement of Foley Catheter to Vaginal Delivery — 21.2; 31.3; 17.1; 14.8 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cervidil 10 MG Vaginal Insert (Drug); Foley Catheter (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Oklahoma
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Median Times From Placement of Foley Catheter to Vaginal Delivery |
21.2; 31.3; 17.1; 14.8 | — |
| SECONDARY To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours |
2; 1; 3; 6; 15; 6 | — |
Summary
In term women presenting for labor induction, combined use of the controlled release dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median time from induction to vaginal delivery by at least four hours compared to the Foley catheter alone.
Eligibility Criteria
Inclusion Criteria
- Cervix ≤2 cm dilated; if 2 cm, <80% effaced
- Gestational age 37 weeks or more
- Singleton gestation
- Cephalic presentation
- Live fetus
Exclusion Criteria
- Contractions more frequent than every 5 minutes
- Premature rupture of membranes
- Prior uterine incision
- Temperature 38C or higher
- Fetal anomalies
- Placenta previa
- Suspected abruption or undiagnosed bleeding more than spotting
- Fetal heart rate tracing prior to enrollment with no more than minimal variability, late decelerations, or more than two variable decelerations
- HIV infection
- Allergy to either latex or dinoprostone
Data sourced from ClinicalTrials.gov (NCT03111316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.