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
Qualifiers
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
Treatments tested in this trial
- Cervical ripening, labor induction
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Aalto University
Lead sponsor
Tampere University Hospital
Collaborator
Jyväskylä Central Hospital
Collaborator
Helsinki University Central Hospital
Collaborator
Source ClinicalTrials.gov