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NCT07414771
Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)
Conditions: Induction of Labor, Cervical Ripening, Cervical Ripening and Induction of Labor
Sex: Female
Ages: 18 Years – 56 Years
Healthy volunteers: No
Phase: NA
Enrollment: 45
Sponsor: Aalto University
Location: Helsinki University Hospital Helsinki HUS
Summary
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
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 weeks of gestation)
* Maternal request for labor induction
* Gestational diabetes
* Preeclampsia (with blood pressure \
Source: ClinicalTrials.gov (NCT07414771). StuddyBuddy aggregates publicly available trial information.