Clinical Trial

Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction

Study acronym: INGA-RCT
Recruiting
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Summary
This study investigates the safety and usability of the new INGA catheter for labor induction. Labor induction is common, with about one in three births being induced. In this study, the INGA catheter will be compared to a currently used method. The INGA catheter is a single-balloon device that works similarly to a Foley catheter but is made from different materials. Feedback will be collected from both healthcare professionals and participating women.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-07-23
notable Enrollment reduced: 90 -> 40 participants 2026-05-28
notable Primary completion pushed: 2026-07-31 -> 2026-09-30 2026-05-28
Trial Details
NCT Number NCT07214948
Lead Sponsor Aalto University
Collaborators: University of Mississippi Medical Center, University of Minnesota
Conditions Induction of Birth, Cervical Ripening, Cervical Ripening and Induction of Labor
Enrollment 40 participants
Start Date 2026-07-03
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-22