Outpatient Labor Induction With the Transcervical Foley Balloon

Status unconfirmed · Not applicable

Conditions studied: Pregnancy, Labor; Forced or Induced, Affecting Fetus or Newborn

In brief

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 foley catheter. The immediate removal technique allows the induction process to begin in the hospital setting, but allows the patient to go home without a foreign body in situ. The investigators hypothesize the outpatient group will spend less time hospitalized prior to discharge. Additionally, the investigators will explore the vaginal delivery rates and maternal/neonatal safety profiles between groups.

Key facts

Study ID

NCT02210598

Run by

University of Southern California

People needed

64

Starts

2014-03-01

Last updated by the study team

2017-04-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Los Angeles County + University of Southern California Medical Center — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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