Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women

Completed · Not applicable

Conditions studied: Pregnancy Related

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. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).

Key facts

Study ID

NCT03472937

Run by

University of Alabama at Birmingham

People needed

126

Starts

2018-05-04

Expected to finish

2019-12-13

Last updated by the study team

2020-02-06

Who can join

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

You may qualify if…

• Age ≥ 18
• Nulliparous
• Singleton gestation
• Gestational age between 39+0 and 42+0 weeks
• Vertex presentation
• Modified Bishop score <5 and cervical dilation ≤ 2 cm
• No prior cesarean or prior uterine surgery
• Resides within 30 minutes of UAB Hospital
• Access to a telephone
• Reliable transportation

You may not qualify if…

• Unsuitable for outpatient cervical ripening (e.g., IUGR, oligohydramnios, polyhydramnios, gestational hypertension or preeclampsia, complex maternal disease, provider discretion). Patients with well controlled Class A or B DM or chronic hypertension will be eligible.
• Latex allergy
• Contraindication to induction of labor
• Evidence of labor
• Fetal demise
• Fetal anomaly
• Inability to give consent (e.g., 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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