Outpatient Versus Inpatient Balloon Catheter Induction of Labor

Not Applicable

Completed

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

• Registration Number: NCT02793609
• Lead Sponsor: Turku University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-08
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Inpatient group	Intervention is to observe women in the ward.	After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward.
Outpatient group	Intervention is to let patient to go home.	After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland