Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)
Recruiting
N/A
Interventional Study
Induction of Labor
Cervical Ripening
Cervical Ripening and Induction of Labor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 56
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 45 (estimated)
- Sponsor
- Aalto University · Other
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
* Examples of diagnoses as the basis for labor induction:
* Post-term pregnancy (≥41 …
Contacts