Patient Satisfaction of Cervical Ripening in an Outpatient Setting

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Cedars-Sinai Medical Center.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 August 28, 2014