Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor

NCT02975167 | Completed

• 1 other identifier: 630-15
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Labor induction is one of the most common obstetric procedures performed in the U.S. In 2012, the last year for which data is available, 23.7% of all deliveries were the result of inductions. Labor induction first requires cervical ripening, which can be accomplished by several different methods. Vaginal or oral prostaglandins, extra amniotic saline infusion, osmotic dilators and transcervical Foley catheters are all widely used instruments for pre-induction cervical ripening. The ideal cervical ripening tool is safe for both mother and fetus, incurs low cost, does not require extensive monitoring, and causes minimal maternal discomfort. The Foley catheter has been found to be both safe and effective, but little is known about patient satisfaction with the device in an in-patient and out-patient setting. The proposed study will investigate patient satisfaction in a randomized controlled trial of in-patient versus out-patient use of Foley catheters.

Conditions

Induction of Labor Affected Fetus / Newborn; Cervical Ripening; Patient Satisfaction

Keywords

Induction of labor; mechanical cervical ripening; patient satisfaction; outpatient; cost savings

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction scores

  The primary outcome will be the total score on Part A of the survey, giving an overall rating of the patients' experience with treatment. Means and standard deviations of the total score will be calculated and reported by treatment group among nulliparous and multiparous patients separately. To address the main hypothesis, an ANOVA (analysis-of-variance) will be performed on an intention-to-treat basis and the stratum (nulliparous vs multiparous) will be controlled for in the analysis. The mean difference between treatment groups will be calculated and reported with a 95% confidence interval for the population difference. A two-sample t-test will be used to test for a significant difference in overall rating between in-patient versus out-patient treatment groups.

  Through study completion - expected to be one year

Secondary Outcomes (1)

• Multiparous versus Nulliparous subjects

  Through study completion - expected to be one year

Study Arms (2)

Inpatient

EXPERIMENTAL

Subjects randomized to this group will receive the same intervention as the outpatient group -- cervical ripening with Foley catheter -- but remain within the hospital. Subjects will be asked to complete a survey assessing their fears, opinions, anxiety, satisfaction and hours of sleep before and after the catheter is placed and removed, respectively. The intervention: randomization to inpatient cervical ripening

Other: Inpatient Cervical Ripening; Procedure: Foley catheter placement; Behavioral: Pre-Foley Questionnaire; Behavioral: Post-Foley Questionnaire; Procedure: Fetal Non-Stress Test

Outpatient

EXPERIMENTAL

Subjects randomized to this group will receive the same intervention as the inpatient group -- cervical ripening with Foley catheter -- but will be discharged home. Subjects will be asked to return to the hospital when the catheter falls out or if 24 hours has elapsed. They will be given detailed instructions and provided a 24 hour phone number to call should they have any concerns. Subjects will be asked to complete a survey assessing their fears, opinions, anxiety, satisfaction and hours of sleep before and after the catheter is placed and removed, respectively. The intervention: randomization to outpatient cervical ripening

Other: Outpatient Cervical Ripening; Procedure: Foley catheter placement; Behavioral: Pre-Foley Questionnaire; Behavioral: Post-Foley Questionnaire; Procedure: Fetal Non-Stress Test

Interventions

Outpatient Cervical Ripening OTHER

The experimental arm of the study will be subjects randomized to the outpatient group. Once randomized, subjects will complete a survey assessing their attitudes, fears, anxiety, satisfaction and expected hours of sleep with outpatient induction of labor. Following placement of the Foley catheter, the subjects will be given detailed instructions for which to return to the hospital, as well as provided a 24 hour phone number to call if they have questions. They will be instructed to return to the hospital once the catheter falls out or if 24 hours has passed since its placement. Upon returning to the hospital, subjects will complete another survey assessing their satisfaction with their induction process.

Also known as: randomization to outpatient cervical ripening

Outpatient

Inpatient Cervical Ripening OTHER

Once randomized to this group, subjects will complete a survey assessing their attitudes, fears, anxiety, satisfaction and expected hours of sleep with inpatient induction of labor. Following placement of the Foley catheter, the subjects will undergo normal labor monitoring until their Foley catheter either falls out or is removed at 24 hours. At this time subjects will complete another survey assessing their satisfaction with their induction process.

Also known as: Randomization to inpatient cervical ripening

Inpatient

Foley catheter placement PROCEDURE

Subjects randomized to both the inpatient and the outpatient arms will receive this intervention following completion of a survey. A Bard(TM) 16G two-way 5cc silicone-coated latex Foley catheter will be placed by a physician-member of the research team using a sterile metal speculum and ring forceps, or by hand, depending on physician preference. Once placed within the cervical canal, the Foley will be filled with 60cc of saline

Inpatient; Outpatient

Pre-Foley Questionnaire BEHAVIORAL

Prior to randomization into inpatient or outpatient arms, all subjects will complete a questionnaire assessing their attitudes, opinions, fears and anxiety regarding induction of labor.

Inpatient; Outpatient

Post-Foley Questionnaire BEHAVIORAL

Following removal of the Foley catheter (either by a physician at 24 hours or spontaneously), all subjects will complete the same questionnaire as prior assessing their attitudes, opinions, fears and anxiety regarding their induction of labor.

Inpatient; Outpatient

Fetal Non-Stress Test PROCEDURE

Following placement of the Foley catheter, all subjects, regardless of arm they are randomized to, will undergo a 20-minute NST. The NST will be read by a physician-member of the research team. If the NST is considered to be suspicious based on the physician's evaluation, subjects randomized to the outpatient arm will be moved to the inpatient arm, but evaluated as part of the outpatient arm on an intent-to-treat basis. All subjects randomized to the inpatient arm will be placed on continuous fetal heart rate monitoring, regardless of physician evaluation of the NST.

Inpatient; Outpatient

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 yo
• Singleton pregnancy
• ≥ 39 weeks gestation
• Vertex presenting fetus

You may not qualify if:

• \< 18 years of age
• Maternal cardiac disease
• Class C diabetes mellitus or worse (as defined by the White classification system for diabetes in pregnancy)
• Gestational or chronic hypertension
• Active or history of venous thromboembolic disease requiring chemical anticoagulation
• Bleeding disorders
• History of placental abruption during current gestation
• Fetal anomalies
• Intrauterine growth restriction \< 5th percentile
• Prior uterine scar
• Vasa or placenta previa
• Active genital herpes
• Non-vertex fetal lie
• Amniotic fluid index (AFI) \< 5cm
• Multiple gestation

Sponsors & Collaborators

• MemorialCare Health System: lead

Study Sites (1)

Miller Women's and Children's Hospital Long Beach

Long Beach, California, 90806, United States

Location

Related Publications (13)

• Martin JA, Hamilton BE, Osterman MJ, Curtin SC, Matthews TJ. Births: final data for 2013. Natl Vital Stat Rep. 2015 Jan 15;64(1):1-65.

  PMID: 25603115 BACKGROUND

• Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol. 2006 Sep;49(3):642-57. doi: 10.1097/00003081-200609000-00022.

  PMID: 16885669 BACKGROUND

• 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.

  PMID: 22419277 BACKGROUND

• Jozwiak M, ten Eikelder M, Oude Rengerink K, de Groot C, Feitsma H, Spaanderman M, van Pampus M, de Leeuw JW, Mol BW, Bloemenkamp K; PROBAAT Study Group. Foley catheter versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and meta-analysis of literature. Am J Perinatol. 2014 Feb;31(2):145-56. doi: 10.1055/s-0033-1341573. Epub 2013 Apr 5.

  PMID: 23564065 BACKGROUND

• Kandil M, Emarh M, Sayyed T, Masood A. Foley catheter versus intra-vaginal misoprostol for induction of labor in post-term gestations. Arch Gynecol Obstet. 2012 Aug;286(2):303-7. doi: 10.1007/s00404-012-2292-8. Epub 2012 Mar 21.

  PMID: 22434058 BACKGROUND

• Sciscione AC, McCullough H, Manley JS, Shlossman PA, Pollock M, Colmorgen GH. A prospective, randomized comparison of Foley catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. Am J Obstet Gynecol. 1999 Jan;180(1 Pt 1):55-60. doi: 10.1016/s0002-9378(99)70149-3.

  PMID: 9914578 BACKGROUND

• Heinemann J, Gillen G, Sanchez-Ramos L, Kaunitz AM. Do mechanical methods of cervical ripening increase infectious morbidity? A systematic review. Am J Obstet Gynecol. 2008 Aug;199(2):177-87; discussion 187-8. doi: 10.1016/j.ajog.2008.05.005.

  PMID: 18674661 BACKGROUND

• 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.

  PMID: 26244535 BACKGROUND

• Maslovitz S, Lessing JB, Many A. Complications of trans-cervical Foley catheter for labor induction among 1,083 women. Arch Gynecol Obstet. 2010 Mar;281(3):473-7. doi: 10.1007/s00404-009-1136-7. Epub 2009 Jun 2.

  PMID: 19488776 BACKGROUND

• 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.

  PMID: 24347259 BACKGROUND

• McKenna DS, Duke JM. Effectiveness and infectious morbidity of outpatient cervical ripening with a Foley catheter. J Reprod Med. 2004 Jan;49(1):28-32.

  PMID: 14976792 BACKGROUND

• 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.

  PMID: 24222365 BACKGROUND

• 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.

  PMID: 32852803 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Vineet Shrivastava, MD

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medine Attending

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 29, 2016
• Study Start: November 1, 2016
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)