Patient Satisfaction of Cervical Ripening in an Outpatient Setting
Safety, Efficacy, and Patient Satisfaction of Cervical Ripening With Transcervical Use of the Foley Catheter in an Outpatient Setting
1 other identifier
interventional
800
1 country
1
Brief Summary
This study examines whether outpatient pre-induction cervical ripening improves patient satisfaction and is safe and effective.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 18, 2012
CompletedFirst Posted
Study publicly available on registry
May 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedMay 25, 2012
May 1, 2012
2.2 years
May 18, 2012
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cesarean section rate
Cesarean delivery rate between groups
2 years
Secondary Outcomes (3)
Patient satisfaction (Pain /discomfort)
2 year
Apgar scores
2 years
NICU admissions
2 years
Study Arms (2)
Outpatient Cervical Ripening
ACTIVE COMPARATORPatients who are randomized to this arm will be allowed discharged home for 12 hours after fetal status is assessed and noted to be reassuring with the foley bulb in place. They will return sooner if they experience rupture of membranes or enter active labor or if the foley bulb falls out.
Inpatient Cervical Ripening
NO INTERVENTIONIn this arm, the fetus will be assessed and a foley bulb placed but these patients will be kept in the hospital.
Interventions
The patient will be discharged home after fetal status is evaluated and noted to be reassuring. A 16 French foley bulb insufflated with 30 cc of normal saline will be placed and secured to the patient's inner thigh.
The patients will not be discharged home after assessment and placement of the foley catheter.
Eligibility Criteria
You may qualify if:
- term pregnancy
- singleton gestation
- cephalic presentation
- scheduled for an induction of labor (acceptable conditions include gestational diabetes, chronic hypertension)
You may not qualify if:
- placenta previa and/or accreta
- low lying placenta
- undiagnosed vaginal bleeding
- preeclampsia
- fetal anomaly
- intrauterine growth restriction
- RH isoimmunization
- fetal demise
- rupture of membranes
- maternal heart disease
- known latex allergy
- active genital herpes infection
- previous uterine surgery
- limited access to a telephone
- excessive distance from the hospital, and/or
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Related Publications (1)
Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
PMID: 11704164BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tania Esaoff, MD
Cedars-Sinai Medical Center, Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow, Maternal Fetal Medicine
Study Record Dates
First Submitted
May 18, 2012
First Posted
May 25, 2012
Study Start
April 1, 2012
Primary Completion
July 1, 2014
Last Updated
May 25, 2012
Record last verified: 2012-05