NCT02842879

Outpatient Foley Cervix Priming

Outpatient Versus Inpatient Cervix Priming With Foley Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hospital de Santa Maria, Portugal · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital. Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score \< 6, gestational age \> 41 weeks or medical indication for induction of labor. Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter. The primary outcome will be to compare the variation of Bishop score (difference between Bishop score before and after application of Foley catheter) between outpatient and inpatient groups. Secondary comparisons include: mode of delivery, Foley catheter application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and maternal pain.

Conditions

• Outpatient Mechanical Cervix Priming

Interventions

Type	Name	Description
OTHER	Outpatient Foley cervix priming	Outpatient setting for cervix priming with Foley catheter

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-07-25
• Last updated: 2016-07-25