Outpatient Versus Inpatient Balloon Catheter Induction of Labor

Outpatient Versus Inpatient Double Balloon Catheter for Induction of Labor: a Randomised Trial

Randomized trial comparing double balloon catheter for induction of labor between in- and outpatient groups.Investigators assess feasibility, clinical effectiveness and patient acceptability of outpatient versus inpatient catheter for induction of labor.

Study Overview

• Status: Completed
• Conditions: Prolonged Pregnancy
• Intervention / Treatment: Other: Intervention is to let patient to go home.; Other: Intervention is to observe women in the ward.

Detailed Description

The objective of this study is to describe labor outcomes in women with double balloon induction catheter of labor. Participants included are women with uncomplicated singleton pregnancy of ≥37- ≤41+5 weeks of gestation. Patients are randomized to two groups: one hundred are randomized to the inpatient and one hundred to the outpatient group.

The main outcome measure is the pain evaluated by VAS at one, five, nine and 13 hours after the placement of double balloon induction catheter. The total hospital stay and induction to delivery interval time is measured. Also the mode of birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20520
    • Turku University Hospital

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:

• uncomplicated pregnancy
• singleton pregnancy
• pregnancy weeks between >37 and <41+5
• the patient is living in 1/2 hour away from hospital

Exclusion Criteria:

• patient has any disease or medication
• multiple pregnancy
• pregnancy week > 41+5
• preterm rupture of membranes
• patient living more than 1/2 hour away from hospital

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Outpatient group; After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home.	Other: Intervention is to let patient to go home.; Intervention is to let patient to go home.
Other: Inpatient group; After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward.	Other: Intervention is to observe women in the ward.; Intervention is to observe women in the ward.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pain measured by visual analogy scale(VAS) after double balloon catheter	Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm.	During the induction of the labor and postpartum period in the hospital.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maternal morbidity	number of mothers having any kind of infection	during the induction of the labor and postpartum period in the hospital
The total hospital stay in both groups	length in days	maximum 14 days
neonatal morbidity	number of babies having any kind of infection	during the induction of the labor and postpartum period in the hospital

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: University of Turku
• Investigators: Principal Investigator: Kirsi M Rinne, PhD, Turku University Hospital; Study Director: Päivi ML Polo, PhD, Turku University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG. 2008 Oct;115(11):1443-50. doi: 10.1111/j.1471-0528.2008.01843.x. Epub 2008 Aug 19.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: June 3, 2016
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: induction of labor; double balloon catheter; mechanical ripening
• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy, Prolonged
• Other Study ID Numbers: T169/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Letter to patients.