This prospective, single-arm clinical investigation evaluates the safety, usability, performance, and preliminary efficacy of the INGA mechanical cervical ripening balloon catheter when used for induction of labor at term. The study is conducted as a medical device investigation in accordance with the Declaration of Helsinki, ICH-GCP principles, and applicable regulatory and ethical requirements. All participants provide written informed consent prior to participation. Mechanical cervical ripening is an established method for labor induction, particularly in women with an unfavorable cervix. Balloon catheters promote cervical ripening through direct mechanical dilation and stimulation of endogenous prostaglandin release, offering a non-pharmacological alternative to pharmacologic methods.
The INGA catheter is a single-use mechanical single-balloon device intended for placement between the fetal membranes and the internal cervical os during a vaginal examination. After insertion, the balloon is filled with sterile saline according to the device instructions for use and maintained under gentle traction. The device may remain in place for up to 24 hours or until spontaneous detachment. Cervical status is assessed prior to catheter insertion and following catheter detachment or removal, and further induction management, including amniotomy and/or oxytocin administration, is performed according to routine clinical practice. Outpatient cervical ripening may be permitted for selected participants based on predefined clinical criteria and local hospital practice.
The study enrolls approximately 30-50 pregnant women at ≥37 weeks of gestation with a singleton pregnancy in cephalic presentation and an unfavorable cervix (Bishop score ≤6) for whom induction of labor has been clinically indicated. Both nulliparous and multiparous women may participate. After providing written informed consent and confirmation of eligibility, participants undergo cervical ripening with the INGA catheter as part of standard induction care. The study does not include a comparison group.
The study collects clinical data during cervical ripening, labor, and delivery in order to characterize device performance in a real-world hospital setting. In addition to clinical outcomes, the investigation includes structured assessments of user experience. Participating women complete questionnaires regarding pain and overall experience related to catheter placement and retention. Healthcare professionals complete structured usability evaluations addressing ease of insertion, handling characteristics, and overall device performance.
Clinical data are collected during cervical ripening, labor, and delivery to characterize device performance in a real-world hospital setting. In addition to clinical outcomes, structured user-reported data are obtained. Participating women complete questionnaires addressing pain and overall experience during catheter placement and retention. Healthcare professionals complete structured evaluations of device usability, ease of insertion, handling characteristics, and overall performance.
Safety is assessed throughout cervical ripening and delivery by systematic monitoring and documentation of adverse events and device-related incidents in accordance with regulatory requirements. As an exploratory pilot investigation, the study is intended to generate preliminary clinical data to support further clinical development and future confirmatory studies.
