Status:
UNKNOWN
Outpatient Labor Induction With the Transcervical Foley Balloon
Lead Sponsor:
University of Southern California
Conditions:
Pregnancy
Labor; Forced or Induced, Affecting Fetus or Newborn
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study represents the first randomized trial comparing traditional inpatient induction with a transcervical foley catheter versus outpatient induction with immediate removal of a transcervical fol...
Detailed Description
This is a randomized controlled trial. Patients who are candidates for labor induction and meet inclusion criteria will be identified in the obstetrics clinic when they are being scheduled for induct...
Eligibility Criteria
Inclusion
- Viable Intrauterine Pregnancy
- Greater than or equal to 37 weeks gestation on date of induction
- Cephalic Presentation
- Medically indicated induction of labor
- AFI greater than or equal to 5
- Patient able to be contacted by phone and demonstrates an understanding of the return instructions
- Cervical Dilation 2cm or less
Exclusion
- Placenta Previa/Low Lying Placenta
- Placenta accreta/increta/percreta
- Undiagnosed vaginal bleeding
- Preeclampsia or HELLP Syndrome
- Intrauterine Growth Restriction
- Rupture of Membranes
- Prior cesarean section or transfundal uterine surgery
- Twin Gestation
- Fetal Anomaly
- Rh Isoimmunization
- Fetal Demise
- Uterine Tachysystole
- Less than 18 years of age
- HIV Infection
- Active herpes, hepatitis B or C infection
- Latex Allergy
- EFW\>4000g
- Chorioamnionitis
- Non-English or Non-Spanish Speaking
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02210598
Start Date
March 1 2014
Last Update
April 19 2017
Active Locations (1)
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1
Los Angeles County + University of Southern California Medical Center
Los Angeles, California, United States, 90033