Patient Satisfaction of Cervical Ripening in an Outpatient Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01605474
Recruitment Status : Unknown
Verified May 2012 by Gregory W. Lau, MD, Cedars-Sinai Medical Center.
Recruitment status was:  Recruiting
First Posted : May 25, 2012
Last Update Posted : May 25, 2012
Information provided by (Responsible Party):
Gregory W. Lau, MD, Cedars-Sinai Medical Center

Brief Summary:
This study examines whether outpatient pre-induction cervical ripening improves patient satisfaction and is safe and effective.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Patient discharged home after foley bulb placement. Other: Inpatient Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2012
Estimated Primary Completion Date : July 2014

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Cesarean section rate [ Time Frame: 2 years ]
    Cesarean delivery rate between groups

Secondary Outcome Measures :
  1. Patient satisfaction (Pain /discomfort) [ Time Frame: 2 year ]
    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.

  2. Apgar scores [ Time Frame: 2 years ]
    Apgar scores

  3. NICU admissions [ Time Frame: 2 years ]
    Neonatal ICU admissions after delivery

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01605474

Contact: Tania F Esakoff, MD 310-423-7568
Contact: Gregory W Lau, MD 310-423-0895

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
Principal Investigator: Tania Esaoff, MD Cedars-Sinai Medical Center, Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine

Responsible Party: Gregory W. Lau, MD, Fellow, Maternal Fetal Medicine, Cedars-Sinai Medical Center Identifier: NCT01605474     History of Changes
Other Study ID Numbers: Pro00026352
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012

Keywords provided by Gregory W. Lau, MD, Cedars-Sinai Medical Center:
foley catheter
foley bulb
induction of labor