An Open, Parallel-group, Randomized, Early Feasibility Trial to Evaluate the Initial Safety and Performance of the INGA Catheter in Labor Induction
Aalto University
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.
Description
Screening Phase Before any study-related procedures are initiated, participants will be asked to read and sign the informed consent form. Once consent is obtained, the following screening assessments will be performed to determine eligibility for participation: * Confirmation of informed consent. * Review of inclusion and exclusion criteria to ensure suitability for the study. * Collection of medical and demographic information, including medical history, concurrent or previous medications, planned delivery date, gestational age, and indication for labor induction. * Cervical assessment by p…
Eligibility
- Age range
- 18–56 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Pregnant women aged ≥18 and ≤56 years * An unripe cervix, ≤6 points according to the Bishop score assessment (0-10-point scale) * Planned induction of labor by balloon catheter method * Gestational age at the time of the study ≥ 37 weeks (gestational age confirmed by ultrasound before the 21st week of pregnancy) * Singleton pregnancy * Cephalic presentation * The subject understands the study information and signs the informed consent Exclusion Criteria: * Preterm induction of labor (\<37 weeks of gestation) * Abnormal Cardiotocography (CTG) at inclusion * Spontaneous…
Interventions
- DeviceINGA Catheter
Insertion of the INGA balloon catheter (medical device) through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours. After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop \< 6, further management follows
- DeviceCurrently used single balloon catheter
Insertion of a balloon catheter through the cervical canal into the uterus for induction of labor.
Locations (2)
- University of Minnesota Medical SchoolMinneapolis, Minnesota
- University of Mississippi Medical CenterJackson, Mississippi