Outpatient Foley For Starting Induction of Labor at TErm (OFFSITE)

The University of Alabama at Birmingham

Status: Completed

Conditions: Pregnancy

Treatments: Other: Outpatient cervical ripening; Other: Inpatient cervical ripening

Study type: Interventional

Funder types: Other

Identifiers

NCT02756689

F151022005

Details and patient eligibility

About

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.

Full description

Induction of labor is necessary in one-fourth of women and a large proportion requires cervical ripening. Cervical ripening is necessary to shorten the time to delivery and increases the chances of a vaginal delivery.

Outpatient cervical ripening is an attractive alternative to women and physicians because of the decreased amount of time spent in the hospital and opportunity for patients to be in the comforts of their home.

The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge.

Enrollment: 129 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

Inpatient cervical Ripening

Active Comparator group

Description:

Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.

Treatment:

Other: Inpatient cervical ripening

Outpatient cervical Ripening

Active Comparator group

Description:

Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.

Treatment:

Other: Outpatient cervical ripening