Outpatient Foley For Starting Induction of Labor at TErm

Completed · Not applicable

Conditions studied: Pregnancy

In brief

The investigators are performing a randomized controlled-trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. This is a pilot study to establish the efficacy of this method in decreasing time as in inpatient and evaluate patient satisfaction.

Key facts

Study ID

NCT02756689

Run by

University of Alabama at Birmingham

People needed

129

Starts

2016-03-01

Expected to finish

2017-10-01

Last updated by the study team

2019-07-09

Who can join

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

You may qualify if…

• Age ≥18
• Multiparous
• Singleton gestation
• Gestational age between 39+0 and 42+0
• Vertex presentation
• Cervix ≤ 3 cm. If cervix is between 2 and 3 cm dilated, it must be <80% effaced
• No prior cesarean section or uterine surgery
• Resides within Jefferson County, Alabama.
• Access to a telephone
• Reliable transportation

You may not qualify if…

• Unsuitable for outpatient Foley placement management (IUGR, oligohydramnios, prior cesarean delivery, gestational hypertension, preeclampsia, or uncontrolled chronic hypertension, complex maternal disease, provider discretion). Any patient with pregestational or gestational diabetes on medications will be excluded.
• Latex allergy
• Contraindication to induction of labor
• Evidence of labor
• Fetal anomaly or demise
• Inability to given consent (non-English speaking, inability to read or write)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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