Recruiting

Observational Study

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT01605474

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Patient discharged home after foley bulb placement.

Inpatient

Study Details

Brief summary:

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

Conditions

Pregnancy

Study ID

NCT01605474

Start date

Apr, 2012

Status verified date

May, 2012

Primary completion date

Jul, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Inpatient

The patients will not be discharged home after assessment and placement of the foley catheter.

Primary outcome measure

  • Cesarean section rate [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Tania F Esakoff, MD

310-423-7568tania.esakoff@cshs.org

Gregory W Lau, MD

310-423-0895gregory.lau@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Tania F Esakoff, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

May 25, 2012

Last verified

May, 2012

Keywords

  • foley catheter
  • foley bulb
  • induction of labor
  • labor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2012-05-25.