Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women (OFFSITE II)

The University of Alabama at Birmingham

Status: Completed

Conditions: Pregnancy Related

Treatments: Procedure: Transcervical Foley catheter placement for cervical ripening

Study type: Interventional

Funder types: Other

Identifiers

NCT03472937

F9999999

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. 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).

Full description

Approximately 20-25% of pregnant women undergo an induction of labor, and a large percentage of these women require cervical ripening in order to "ready" the cervix for induction. In the setting of an unfavorable cervix, induction of labor with oxytocin alone can be associated with longer times to delivery, uterine tachysystole (uterine contractions that are too frequent), and increased rates of cesarean delivery.

Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own 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 from the hospital.

Enrollment: 126 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Inpatient cervical ripening group

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:

Procedure: Transcervical Foley catheter placement for cervical ripening

Outpatient cervical ripening group

Active Comparator group

Description:

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

Treatment:

Procedure: Transcervical Foley catheter placement for cervical ripening