RecruitingNot ApplicableNCT07414771

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

A Medical Device Pilot Study to Evaluate the Safety and Usability of the Inga Catheter in Labor Induction

Sponsor

Aalto University

Enrollment

45 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

cervical ripening Induction of labor Cervical Ripening and Induction of Labor

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 56 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Cervical ripening, labor induction for people with cervical ripening and induction of labor, induction of labor, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECervical ripening, labor induction

This study uses the INGA cervical ripening balloon catheter for labor induction, with standardized insertion and saline filling according to device instructions, allowing the balloon to remain in place up to 24 hours. The trial systematically collects data on catheter usability, insertion experience, patient pain, retention time, and delivery outcomes, as well as feedback from both participants and healthcare professionals regarding device performance and usability. Cervical status is evaluated using the Bishop score before and after catheter use.