NCT02793609

Outpatient Versus Inpatient Balloon Catheter Induction of Labor

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prolonged Pregnancy

Interventions

Type	Name	Description
OTHER	Intervention is to let patient to go home.	Intervention is to let patient to go home.
OTHER	Intervention is to observe women in the ward.	Intervention is to observe women in the ward.

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2016-06-08
• Last updated: 2020-06-09

Locations

1 site across 1 country: Finland