Patient Satisfaction of Cervical Ripening in an Outpatient Setting
This study is currently recruiting participants.
Verified May 2012 by Cedars-Sinai Medical Center
Sponsor:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Gregory W. Lau, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01605474
First received: May 18, 2012
Last updated: May 23, 2012
Last verified: May 2012
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Purpose
This study examines whether outpatient pre-induction cervical ripening improves patient satisfaction and is safe and effective.
| Condition | Intervention |
|---|---|
|
Pregnancy |
Other: Patient discharged home after foley bulb placement. Other: Inpatient |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety, Efficacy, and Patient Satisfaction of Cervical Ripening With Transcervical Use of the Foley Catheter in an Outpatient Setting |
Further study details as provided by Cedars-Sinai Medical Center:
Primary Outcome Measures:
- Cesarean section rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]Cesarean delivery rate between groups
Secondary Outcome Measures:
- Patient satisfaction (Pain /discomfort) [ Time Frame: 2 year ] [ Designated as safety issue: No ]Patient satisfaction. Administering a questionaire on which the patient will rate her pain/discomofrt during the placement of the foley bulb and her pain/discomfort while undergoing labor. The Wong Baker Faces scale will be used to assess this measure.
- Apgar scores [ Time Frame: 2 years ] [ Designated as safety issue: No ]Apgar scores
- NICU admissions [ Time Frame: 2 years ] [ Designated as safety issue: No ]Neonatal ICU admissions after delivery
| Estimated Enrollment: | 800 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Outpatient Cervical Ripening
Patients 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.
|
Other: Patient discharged home after foley bulb placement.
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.
Other Name: Foley bulb (16 French)
|
|
No Intervention: Inpatient Cervical Ripening
In this arm, the fetus will be assessed and a foley bulb placed but these patients will be kept in the hospital.
|
Other: Inpatient
The patients will not be discharged home after assessment and placement of the foley catheter.
Other Name: Foley Bulb (16 French)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- term pregnancy
- singleton gestation
- cephalic presentation
- scheduled for an induction of labor (acceptable conditions include gestational diabetes, chronic hypertension)
Exclusion criteria include the following:
- 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
- unreliable transportation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605474
Contacts
| Contact: Tania F Esakoff, MD | 310-423-7568 | tania.esakoff@cshs.org |
| Contact: Gregory W Lau, MD | 310-423-0895 | gregory.lau@cshs.org |
Locations
| United States, California | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Principal Investigator: Tania F Esakoff, MD | |
| Sub-Investigator: Gregory W Lau, MD | |
| Sub-Investigator: Steve Rad, MD | |
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
| Principal Investigator: | Tania Esaoff, MD | Cedars-Sinai Medical Center, Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Gregory W. Lau, MD, Fellow, Maternal Fetal Medicine, Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT01605474 History of Changes |
| Other Study ID Numbers: | Pro00026352 |
| Study First Received: | May 18, 2012 |
| Last Updated: | May 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cedars-Sinai Medical Center:
|
foley catheter foley bulb induction of labor labor |
ClinicalTrials.gov processed this record on May 16, 2013