Clinical trial NCT02756689: Outpatient Foley For Starting Induction of Labor at TErm
Official title: Outpatient Foley for Starting Induction of Labor at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
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: 2016-04-29
Enrollment: 129
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. This is a pilot study to establish the efficacy of this method in decreasing time as in inpatient and evaluate patient satisfaction.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total Time From Admission to Delivery
timeFrame: From baseline to the time of delivery (baseline is from admission), up to 7 days
Secondary outcomes:
measure: Total Hospital Duration
timeFrame: From admission time to the hospital until discharge from the hospital, up to 7 days
measure: Number of Participants Using Acetaminophen
timeFrame: From placement of Foley bulb to 24 hours.
measure: Number of Participants Calling the Obstetrical Triage Unit
timeFrame: From placement of Foley bulb to 24 hours.
measure: Number of Participants Admitted Prior to the Scheduled Induction of Labor Time
timeFrame: From placement of Foley bulb to 24 hours.
measure: Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission
timeFrame: From placement of Foley bulb to 24 hours.
measure: Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.
timeFrame: From placement until 30 minutes.
measure: Total Duration of Time of Neuraxial Anesthesia Use
timeFrame: Assessed from baseline to delivery, up to 3 days
measure: Total Duration of Time From Rupture of Membranes Until Delivery
timeFrame: Assessed from baseline to delivery, up to 3 days
measure: Maximum Oxytocin Rate
timeFrame: Assessed from baseline to delivery, up to 3 days
measure: Highest Maternal Intrapartum Temperature
timeFrame: Assessed from baseline to delivery, up to 3 days
measure: Number of Participants With Chorioamnionitis
timeFrame: Assessed from baseline to delivery.
measure: Number of Participants With Meconium-stained Fluid
timeFrame: Assessed from baseline to delivery.
measure: Number of Participants With Neonates With Shoulder Dystocia
timeFrame: Assessed at delivery.
measure: Number of Participants Who Had a Cesarean Delivery
timeFrame: Assessed from baseline to delivery.
measure: Number of Participants With an Operative Vaginal Delivery
timeFrame: Assessed at delivery.
measure: Postpartum Hemorrhage
timeFrame: Assessed at delivery.
measure: Number of Participants With Endometritis
timeFrame: Assessed from delivery until 30 days post-discharge.
measure: Number of Participants With Readmission Within 30 Days
timeFrame: Assessed from time of discharge until 30 days post-discharge.
measure: Number of Neonates With a 5-minute Apgar Score Less Than 7
timeFrame: Assessed at time of delivery up to 5-minutes post-delivery.
measure: Number of Neonates With Umbilical Artery Cord pH < 7.1
timeFrame: Assessed at time of delivery up to 5-minutes post-delivery.
measure: Number of Neonates With an Umbilical Cord Artery Base Deficit Less Than Negative 12
timeFrame: Assessed at time of delivery up to 5-minutes post-delivery.
measure: Number of Neonates With Birth Injuries
timeFrame: Assessed at time of delivery up to time of neonatal discharge, up to 30 days.
measure: Number of Neonates Admitted to the Neonatal Intensive Care Unit Admissions
timeFrame: Assessed at time of delivery up to time of neonatal discharge, up to 30-days
measure: Patient Satisfaction Six Simple Questions, Q1
timeFrame: At discharge.
measure: Patient Satisfaction (Six Simple Questions, Question 2)
timeFrame: At discharge
measure: Patient Satisfaction (Six Simple Questions, Question 3)
timeFrame: At discharge
measure: Patient Satisfaction (Six Simple Questions, Question 4)
timeFrame: At discharge
measure: Patient Satisfaction (Six Simple Questions, Question 5)
timeFrame: At discharge
measure: Patient Satisfaction (Six Simple Questions, Question 6)
timeFrame: At discharge
measure: Patient Satisfaction (Lady-X Survey, Question 1)
timeFrame: At discharge
measure: Patient Satisfaction (Lady-X Survey, Question 2)
timeFrame: At discharge
measure: Patient Satisfaction (Lady-X Survey, Question 3)
timeFrame: At discharge
measure: Patient Satisfaction (Lady-X Survey, Question 4)
timeFrame: At discharge
measure: Patient Satisfaction (Lady-X Survey, Question 5)
timeFrame: At discharge
measure: Patient Satisfaction (Lady-X Survey, Question 6)
timeFrame: At discharge
measure: Patient Satisfaction (Lady-X, Question 7)
timeFrame: At discharge
measure: Patient Satisfaction (Labor Pain Scale, Question 1)
timeFrame: At discharge
measure: Patient Satisfaction (Labor Pain Scale, Question 2)
timeFrame: At discharge
measure: Patient Satisfaction (Labor Pain Scale, Question 3)
timeFrame: At discharge
measure: Patient Satisfaction (Labor Pain Scale, Question 4)
timeFrame: At discharge
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UAB, Department of Maternal-Fetal Medicine
name: Spencer G Kuper, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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: McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002.
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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: Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, Harper LM. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):94-101. doi: 10.1097/AOG.0000000000002678.