NCT04271722

Clinical Evaluation of Cervical Ripening in the Outpatient Setting

Clinical Evaluation of Cervical Ripening in the Outpatient Setting Using Mifepristone Versus Balloon Catheter: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Centro Hospitalar Lisboa Norte · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.

Detailed description

Artificial induction of labour is currently required in 25-30% of all pregnancies, in high-resource countries. While the pharmacological modifications to the collagen matrix of the cervix, that allow it to dilate (cervical ripening) occur spontaneously in many women, allowing labour to be induced with oxytocin, in others the process needs to be triggered artificially. Cervical ripening is traditionally accomplished with prostaglandins or mechanical agents, in processes that typically require 12-24 hours of hospital stay. More recently, a limited number of hospitals have shifted towards starting the process in house, but then allowing women to return home and be re-evaluated on the following day. The main aims this study is to compare efficacy and patient satisfaction of mifepristone vs balloon catheter for cervical ripening.

Conditions

• Labor; Forced or Induced, Affecting Fetus or Newborn
• Labor Onset and Length Abnormalities

Interventions

Type	Name	Description
OTHER	Cervical ripening	Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.

Timeline

• Start date: 2020-01-15
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2020-02-17
• Last updated: 2024-05-31

Locations

1 site across 1 country: Portugal