Clinical trial NCT03472937: Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women
Official title: Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women: A Randomized-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Mechanical cervical ripening
Transcervical catheter
Foley catheter for labor induction
Cervical ripening
Induction of labor
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total time from admission to delivery
timeFrame: From baseline to the time of delivery (baseline is from admission)
Secondary outcomes:
measure: Modified Bishop score on admission
timeFrame: At baseline
measure: Evaluation of patient satisfaction with care
timeFrame: Within 2-4 days after delivery
measure: Evaluation of patient experience on labor and delivery
timeFrame: Within 2-4 days after delivery
measure: Evaluation of pain experienced during childbirth
timeFrame: From placement of Foley bulb to delivery
measure: Vaginal bleeding greater than bloody show
timeFrame: From placement of Foley bulb to delivery
measure: Total hospital duration
timeFrame: From hospital admission to hospital discharge (generally less than one week)
measure: Rates of acetaminophen use
timeFrame: From placement of Foley bulb to 24 hours
measure: Rates of calls to the obstetrical triage unit
timeFrame: From placement of Foley bulb to 24 hours
measure: Early admission or early visit to the obstetrical triage unit prior to scheduled induction of labor time
timeFrame: From placement of Foley bulb to 24 hours
measure: Rates of spontaneous rupture of membranes between Foley bulb placement and admission
timeFrame: From placement of Foley bulb to 24 hours
measure: Non-reassuring fetal heart rate tracings 30-minutes after Foley bulb placement
timeFrame: From placement of Foley bulb to 30 minutes
measure: Total duration of time of neuraxial anesthesia use
timeFrame: From baseline to delivery
measure: Total time of oxytocin infusion
timeFrame: From baseline to delivery
measure: Maximum oxytocin rate
timeFrame: From baseline to delivery
measure: Highest maternal intrapartum temperature
timeFrame: From baseline to delivery
measure: Rates of chorioamnionitis
timeFrame: From baseline to delivery
measure: Rates of endometritis
timeFrame: From delivery until 30 days post-discharge
measure: Mode of delivery
timeFrame: From baseline to delivery
measure: Postpartum hemorrhage
timeFrame: At delivery
measure: Rates of hospital readmission within 30 days
timeFrame: From hospital discharge until 30 days post-discharge
measure: Rates of 5-minute Apgar score <7
timeFrame: From time of delivery up to 5 minutes post-delivery
measure: Rates of umbilical cord artery pH <7.1
timeFrame: From time of delivery up to 5 minutes post-delivery
measure: Rates of umbilical cord artery base deficit <-12
timeFrame: From time of delivery up to 5 minutes post-delivery
measure: Rates of neonatal intensive care unit admissions
timeFrame: After delivery and before neonatal discharge (generally less than one week)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Elizabeth B Ausbeck, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.
citation: Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
citation: Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
citation: Ausbeck EB, Jauk VC, Xue Y, Files P, Kuper SG, Subramaniam A, Casey BM, Szychowski JM, Harper LM, Tita AT. Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):597-606. doi: 10.1097/AOG.0000000000004041.