Outpatient Foley For Starting Induction of Labor at TErm (OFFSITE)

Outpatient Foley for Starting Induction of Labor at Term

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Inpatient cervical ripening; Other: Outpatient cervical ripening

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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inpatient cervical Ripening; 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.	Other: Inpatient cervical ripening; Subjects will undergo cervical ripening in the inpatient setting.
Active Comparator: Outpatient cervical Ripening; Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.	Other: Outpatient cervical ripening; Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Time From Admission to Delivery	From baseline to the time of delivery (baseline is from admission), up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Hospital Duration		From admission time to the hospital until discharge from the hospital, up to 7 days
Number of Participants Using Acetaminophen		From placement of Foley bulb to 24 hours.
Number of Participants Calling the Obstetrical Triage Unit		From placement of Foley bulb to 24 hours.
Number of Participants Admitted Prior to the Scheduled Induction of Labor Time		From placement of Foley bulb to 24 hours.
Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission		From placement of Foley bulb to 24 hours.
Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.		From placement until 30 minutes.
Total Duration of Time of Neuraxial Anesthesia Use		Assessed from baseline to delivery, up to 3 days
Total Duration of Time From Rupture of Membranes Until Delivery		Assessed from baseline to delivery, up to 3 days
Maximum Oxytocin Rate		Assessed from baseline to delivery, up to 3 days
Highest Maternal Intrapartum Temperature		Assessed from baseline to delivery, up to 3 days
Number of Participants With Chorioamnionitis		Assessed from baseline to delivery.
Number of Participants With Meconium-stained Fluid		Assessed from baseline to delivery.
Number of Participants With Neonates With Shoulder Dystocia		Assessed at delivery.
Number of Participants Who Had a Cesarean Delivery		Assessed from baseline to delivery.
Number of Participants With an Operative Vaginal Delivery		Assessed at delivery.
Postpartum Hemorrhage		Assessed at delivery.
Number of Participants With Endometritis		Assessed from delivery until 30 days post-discharge.
Number of Participants With Readmission Within 30 Days		Assessed from time of discharge until 30 days post-discharge.
Number of Neonates With a 5-minute Apgar Score Less Than 7	Apgar scores are assigned to all births. These are universally performed and assigned in the United States. The scoring system is between 0-10. 0 is the minimum score and 10 is the maximum. Lower scores are worse than higher scores.	Assessed at time of delivery up to 5-minutes post-delivery.
Number of Neonates With Umbilical Artery Cord pH < 7.1		Assessed at time of delivery up to 5-minutes post-delivery.
Number of Neonates With an Umbilical Cord Artery Base Deficit Less Than Negative 12	Base deficit is a lab value.	Assessed at time of delivery up to 5-minutes post-delivery.
Number of Neonates With Birth Injuries	Cephalohematomas, subgaleal hematomas, fracture of the clavicle, and scalp lacerations	Assessed at time of delivery up to time of neonatal discharge, up to 30 days.
Number of Neonates Admitted to the Neonatal Intensive Care Unit Admissions	The rates of neonatal intensive care unit admissions will be calculated.	Assessed at time of delivery up to time of neonatal discharge, up to 30-days
Patient Satisfaction Six Simple Questions, Q1	Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1	At discharge.
Patient Satisfaction (Six Simple Questions, Question 2)	Assessed through validated survey (Six simple questions, Q-2). Question 2: The person(s) responsible for my care are/were caring and compassionate. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1	At discharge
Patient Satisfaction (Six Simple Questions, Question 3)	Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 3: Problems that have arisen up to now have not been dealt with effectively. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1	At discharge
Patient Satisfaction (Six Simple Questions, Question 4)	Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 4: My needs have been addressed with appropriate consideration for my time. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1	At discharge
Patient Satisfaction (Six Simple Questions, Question 5)	Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 5: The overall organization of my ca re has not been appropiate. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1	At discharge
Patient Satisfaction (Six Simple Questions, Question 6)	Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 6: I would choose the same type of care for my next pregnancy. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1	At discharge
Patient Satisfaction (Lady-X Survey, Question 1)	Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 1: Presence of healthcare professionals during my birth. Scale 1-3. 1 = At all times, 2 = Most of the time, 3 = rarely Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3	At discharge
Patient Satisfaction (Lady-X Survey, Question 2)	Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 2: Information given by the healthcare professionals during childbirth. Scale 1-3. 1 = I felt very well informed by the healthcare professionals, 2 = I felt adequately informed by the healthcare professionals, 3 = I felt inadequately informed by the healthcare professionals. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3	At discharge
Patient Satisfaction (Lady-X Survey, Question 3)	Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 3: Taking your wishes seriously during childbirth. Scale 1-3. 1 = Very seriously, 2 = sufficiently, 3 = insufficiently Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3	At discharge
Patient Satisfaction (Lady-X Survey, Question 4)	Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 4: Emotional support by healthcare professionals during childbirth. Scale 1-3. 1 = Very well supported, 2 = adequately supported, 3 = inadequately supported. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3	At discharge
Patient Satisfaction (Lady-X Survey, Question 5)	Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 5: Feeling of security during childbirth: Scale 1-3. 1 = very safe, 2 = sufficiently safe, 3 = insufficiently safe. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3	At discharge
Patient Satisfaction (Lady-X Survey, Question 6)	Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 6: Worries about the health of your child during childbirth. Scale 1-3; 1 = not worried, 2 = somewhat worried, 3 = very worried. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3	At discharge
Patient Satisfaction (Lady-X, Question 7)	Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 7: Time until first contact with your child. Scale 1-3. 1 = Did not take long, 2 = Took quite a long time, 3 = Took a very long time. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3	At discharge
Patient Satisfaction (Labor Pain Scale, Question 1)	Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 1: Worst amount of pain experienced during labor. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0	At discharge
Patient Satisfaction (Labor Pain Scale, Question 2)	Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 2: Overall pain experienced during labor. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0	At discharge
Patient Satisfaction (Labor Pain Scale, Question 3)	Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 3: Worse amount of pain experienced during the placement of the Foley balloon. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0	At discharge
Patient Satisfaction (Labor Pain Scale, Question 4)	Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 4: How likely are you to recommend your method of induction to a friend or family member. Scale 0-100. 0= very unlikely, 100= very likely. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0	At discharge

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Spencer G Kuper, MD, UAB, Department of Maternal-Fetal Medicine

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.
• 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.
• WHO Recommendations for Induction of Labour. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK131963/
• Wing DA. Labor induction with misoprostol. Am J Obstet Gynecol. 1999 Aug;181(2):339-45. doi: 10.1016/s0002-9378(99)70558-2.
• Alfirevic Z, Kelly AJ, Dowswell T. Intravenous oxytocin alone for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD003246. doi: 10.1002/14651858.CD003246.pub2.
• Farmer KC, Schwartz WJ 3rd, Rayburn WF, Turnbull G. A cost-minimization analysis of intracervical prostaglandin E2 for cervical ripening in an outpatient versus inpatient setting. Clin Ther. 1996 Jul-Aug;18(4):747-56; discussion 702. doi: 10.1016/s0149-2918(96)80224-4.
• 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.
• 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.
• Edwards RK, Szychowski JM, Berger JL, Petersen M, Ingersoll M, Bodea-Braescu AV, Lin MG. Foley catheter compared with the controlled-release dinoprostone insert: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1280-1287. doi: 10.1097/AOG.0000000000000238.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Induction of labor; Cervical ripening; Mechanical cervical ripening; Transcervical catheter; Foley catheter for labor induction
• Other Study ID Numbers: F151022005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO