Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-56
SponsorAalto University
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Preterm induction of labor (<37 weeks of gestation)
Abnormal Cardiotocography (CTG) at inclusion
Spontaneous rupture of membranes at inclusion
Clinically significant vaginal bleeding with a need of hospitalization in the third trimester
Trial design
Treatments tested in this trial
- INGA Catheter
- Currently used single balloon catheter
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Aalto University
Lead sponsor
University of Mississippi Medical Center
Collaborator
University of Minnesota
Collaborator
Source ClinicalTrials.gov