NCT04342741

Inpatient and Outpatient Balloon Catheter Cervical Ripening

A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting.

Detailed description

The study evaluated the efficacy and safety of outpatient versus inpatient Foley catheter cervical ripening and patients' satisfaction. Sixty low-risk women were randomized to outpatient and inpatient management of intracervical Foley catheter digital insertion. The outpatient group was provided with verbal and written 24-hours contact information and instructions. Both groups were reassessed the next morning unless labor had begun or the catheter had dropped off.

Conditions

• Caesarean Section; Infection

Interventions

Type	Name	Description
DEVICE	Foley catheter cervical ripening	Participants were assessed when labour was established or the following morning.

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2020-04-13
• Last updated: 2020-04-13

Locations

1 site across 1 country: Malaysia