- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03472937
Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women (OFFSITE II)
Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women: A Randomized-Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Inpatient cervical ripening group
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.
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Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.
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ACTIVE_COMPARATOR: Outpatient cervical ripening group
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.
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Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Total time from admission to delivery
Time Frame: From baseline to the time of delivery (baseline is from admission)
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From baseline to the time of delivery (baseline is from admission)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Bishop score on admission
Time Frame: At baseline
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At baseline
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Evaluation of patient satisfaction with care
Time Frame: Within 2-4 days after delivery
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Assessed through survey adapted from "Six Simple Questions Survey," which has been published by Harvey et al (Harvey et al.
Evaluation of satisfaction with midwifery care.
Midwifery.
2002 Dec; 18(4):260-7.)
This survey has 6 questions to assess perceptions of satisfaction with care.
The questions include questions such as, "I had appropriate and adequate control over my care," "The person(s) responsible for my care are/were caring and compassionate," and "Problems that have arisen up to now have not been dealt with effectively."
The scare ranges from 1-7, with 1 representing Strongly Disagree and 7 representing Strongly Agree.
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Within 2-4 days after delivery
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Evaluation of patient experience on labor and delivery
Time Frame: Within 2-4 days after delivery
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Assessed through survey adapted from "Labor and Delivery Index (LADY-X" Survey, which has been published by Gartner et al (Gartner et al.
Calculating Preference Weights for the Labor and Delivery Index: A Discrete Choice Experiment on Women's Birth Experiences.
Value Health.
2015 Sep; 18(6):856-864.)
This survey has 7 questions to assess experiences during labor and birth.
Each question then has 3 answer choices that describe how good/poor the experience was.
An example of a question is, "Taking your wishes seriously during childbirth."
The answers then include "very seriously, sufficiently seriously, or insufficiently seriously."
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Within 2-4 days after delivery
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Evaluation of pain experienced during childbirth
Time Frame: From placement of Foley bulb to delivery
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Assessed through survey that contains 4 questions.
The first 3 questions assess pain (worst pain during labor, overall pain during labor, and worse pain during placement of the Foley balloon).
The 4th question asks how likely a patient is to recommend her method of induction to a friend/family member.
The scale ranges from 0-100, with 0 representing no pain or very unlikely and 100 representing pain as bad as it could possibly be or very likely.
The patient is instructed to place a hash mark over the line.
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From placement of Foley bulb to delivery
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Vaginal bleeding greater than bloody show
Time Frame: From placement of Foley bulb to delivery
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Vaginal bleeding that is like a period or more
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From placement of Foley bulb to delivery
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Total hospital duration
Time Frame: From hospital admission to hospital discharge (generally less than one week)
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From hospital admission to hospital discharge (generally less than one week)
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Rates of acetaminophen use
Time Frame: From placement of Foley bulb to 24 hours
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From placement of Foley bulb to 24 hours
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Rates of calls to the obstetrical triage unit
Time Frame: From placement of Foley bulb to 24 hours
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From placement of Foley bulb to 24 hours
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Early admission or early visit to the obstetrical triage unit prior to scheduled induction of labor time
Time Frame: From placement of Foley bulb to 24 hours
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From placement of Foley bulb to 24 hours
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Rates of spontaneous rupture of membranes between Foley bulb placement and admission
Time Frame: From placement of Foley bulb to 24 hours
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From placement of Foley bulb to 24 hours
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Non-reassuring fetal heart rate tracings 30-minutes after Foley bulb placement
Time Frame: From placement of Foley bulb to 30 minutes
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From placement of Foley bulb to 30 minutes
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Total duration of time of neuraxial anesthesia use
Time Frame: From baseline to delivery
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From baseline to delivery
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Total time of oxytocin infusion
Time Frame: From baseline to delivery
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From baseline to delivery
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Maximum oxytocin rate
Time Frame: From baseline to delivery
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From baseline to delivery
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Highest maternal intrapartum temperature
Time Frame: From baseline to delivery
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From baseline to delivery
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Rates of chorioamnionitis
Time Frame: From baseline to delivery
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From baseline to delivery
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Rates of endometritis
Time Frame: From delivery until 30 days post-discharge
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From delivery until 30 days post-discharge
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Mode of delivery
Time Frame: From baseline to delivery
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Rates of vaginal delivery, cesarean delivery, and operative vaginal delivery (vacuum or forceps)
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From baseline to delivery
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Postpartum hemorrhage
Time Frame: At delivery
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At delivery
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Rates of hospital readmission within 30 days
Time Frame: From hospital discharge until 30 days post-discharge
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From hospital discharge until 30 days post-discharge
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Rates of 5-minute Apgar score <7
Time Frame: From time of delivery up to 5 minutes post-delivery
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From time of delivery up to 5 minutes post-delivery
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Rates of umbilical cord artery pH <7.1
Time Frame: From time of delivery up to 5 minutes post-delivery
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From time of delivery up to 5 minutes post-delivery
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Rates of umbilical cord artery base deficit <-12
Time Frame: From time of delivery up to 5 minutes post-delivery
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From time of delivery up to 5 minutes post-delivery
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Rates of neonatal intensive care unit admissions
Time Frame: After delivery and before neonatal discharge (generally less than one week)
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After delivery and before neonatal discharge (generally less than one week)
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Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth B Ausbeck, MD, University of Alabama at Birmingham
Publications and helpful links
General Publications
- 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.
- Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
- Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
- ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
- Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3.
- Amorosa JM, Stone JL. Outpatient cervical ripening. Semin Perinatol. 2015 Oct;39(6):488-94. doi: 10.1053/j.semperi.2015.07.014. Epub 2015 Sep 11.
- O'Brien JM, Mercer BM, Cleary NT, Sibai BM. Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 1995 Dec;173(6):1855-9. doi: 10.1016/0002-9378(95)90440-9.
- McKenna DS, Costa SW, Samuels P. Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol. 1999 Jul;94(1):11-4. doi: 10.1016/s0029-7844(99)00244-6.
- Rayburn W, Gosen R, Ramadei C, Woods R, Scott J Jr. Outpatient cervical ripening with prostaglandin E2 gel in uncomplicated postdate pregnancies. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1417-23. doi: 10.1016/0002-9378(88)90376-6.
- Sawai SK, O'Brien WF, Mastrogiannis DS, Krammer J, Mastry MG, Porter GW. Patient-administered outpatient intravaginal prostaglandin E2 suppositories in post-date pregnancies: a double-blind, randomized, placebo-controlled study. Obstet Gynecol. 1994 Nov;84(5):807-10.
- Biem SR, Turnell RW, Olatunbosun O, Tauh M, Biem HJ. A randomized controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction. J Obstet Gynaecol Can. 2003 Jan;25(1):23-31. doi: 10.1016/s1701-2163(16)31079-9.
- Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.
- Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- F9999999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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