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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
INGA Catheter
DeviceInsertion 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
Currently used single balloon catheter
DeviceInsertion of a balloon catheter through the cervical canal into the uterus for induction of labor.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: INGA CatheterExperimental treatment 1 intervention
Group B: Currently used induction catheterOther 1 intervention
Trial outcomes
Primary outcomes
1
Bishop Score Change
Change in Bishop score (A scale from 1 to 10) during cervical ripening, with scores assessed before catheter insertion and after catheter detachment.
Time frame
From catheter insertion to detachmentSecondary outcomes
1
Placement success
Whether the catheter is placed successfully
Time frame
At catheter insertion2
Retention time of balloon catheter
The time the balloon catheter remains in the cervix for cervical ripening
Time frame
From catheter placement to detachment, 0-24 hours3
Induction to delivery interval
Time from initiation of labor induction (balloon catheter insertion) to the delivery of the neonate. This includes both the cervical ripening phase and active labor. The outcome will capture the total duration of the induction-to-delivery process.
Time frame
rom the start of balloon catheter insertion until the birth of the neonate, 0-48 hours4
Mode of delivery
The type of delivery for the participant, categorized as vaginal, vaginal operative or cesarean delivery
Time frame
From enrolment to birthLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aalto University
Lead sponsor
University of Mississippi Medical Center
Collaborator
University of Minnesota
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: