Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-56
SponsorAalto University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women aged ≥18 and ≤56 years
An unripe cervix, ≤6 points according to the Bishop assessment (0-10 point scale)
Planned induction of labor by mechanical balloon catheter method
Post-term pregnancy (≥41 weeks of gestation)
Disqualifiers
Preterm induction of labor (<37 weeks of gestation)
Pathological CTG at inclusion
Spontaneous rupture of membranes at inclusion
Clinically significant vaginal bleeding with need of hospitalization in the third trimester
Trial design
Design model
Single group
Treatments tested in this trial
Cervical ripening, labor induction
DeviceThis 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: INGA catheter for cervical ripeningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Bishop score
The change in Bishop score (on a scale from 0 to 10) during cervical ripening assessed prior to catheter insertion and after catheter detachment
Time frame
From catheter insertion to detachmentSecondary outcomes
1
Successful catheter placement (clinical assessment by investigator)
Successful placement defined as correct intrauterine positioning of the catheter as confirmed clinically by the inserting healthcare professional at the time of insertion.
Time frame
Periprocedural (at the time of catheter insertion)2
Retention time of the balloon catheter
Duration (in hours) that the balloon catheter remains in place in the cervix for cervical ripening.
Time frame
From balloon catheter placement to catheter detachment (up to 24 hours)3
Induction to delivery interval
Time (in hours) from initiation of labor induction (balloon catheter insertion) to delivery of the neonate. This includes both the cervical ripening phase and active labor.
Time frame
From balloon catheter insertion to delivery of the neonate (assessed up to 48 hours after induction initiation)4
Mode of delivery
The type of delivery for the participant, categorized as vaginal delivery, instrumental vaginal delivery, or cesarean section.
Time frame
From enrolment to birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aalto University
Lead sponsor
Tampere University Hospital
Collaborator
Jyväskylä Central Hospital
Collaborator
Helsinki University Central Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: