Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)

The goal of this clinical study is to evaluate a new mechanical balloon catheter (INGA) used to prepare the cervix for labor induction in pregnant women at term. The study aims to assess the safety, usability, and performance of the INGA catheter when used for cervical ripening before labor. Researchers will also collect feedback from healthcare professionals and participants about the use of the device. Participants are pregnant women at term with a single baby in a head-down position who meet the study eligibility criteria. Participants will: * have the INGA balloon catheter inserted as part of labor induction, * receive standard clinical care according to hospital practice, * provide information about their experience and outcomes related to the device. The results of this study will help determine whether the INGA catheter is safe and suitable for use in cervical ripening during labor induction.

NCT Number	NCT07414771
Lead Sponsor	Aalto University Collaborators: Tampere University Hospital, Jyväskylä Central Hospital, Helsinki University Central Hospital
Conditions	Induction of Labor, Cervical Ripening, Cervical Ripening and Induction of Labor
Enrollment	45 participants
Start Date	2026-07-01
Primary Completion	2026-09-30 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-22