NCT03752073

Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Ochsner Health System · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.

Detailed description

Term, low risk patients requesting elective induction of labor who desire pre-induction cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients present to the hospital for their scheduled induction of labor approximately 12 hours later. We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent efficacy in cervical ripening, but that pain scores and patient satisfaction will be better with the hygroscopic dilators.

Conditions

• Induction of Labor

Interventions

Type	Name	Description
DEVICE	Trans-cervical cervical balloon	Insertion of Foley Catheter
DEVICE	Hygroscopic cervical dilator	Insertion of Dilapan-s

Timeline

• Start date: 2019-03-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2018-11-23
• Last updated: 2023-04-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study