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



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:6/9/2018
Start Date:May 4, 2018
End Date:May 2020
Contact:Elizabeth B Ausbeck, MD
Email:eausbeck@uabmc.edu
Phone:205-996-2505

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Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women: A Randomized-Controlled Study

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).

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.

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)
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-996-2502
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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mi
from
Birmingham, AL
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