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.

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.

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 <150/100)
  • Well-controlled hypertension
  • Cholestasis of pregnancy
  • Humanitarian or psychosocial reasons

• Gestational age at the time of the study ≥ 37 weeks (gestational age confirmed by ultrasound before the 21st week of pregnancy)

• Singleton pregnancy

• Cephalic presentation

• The subject understands the study information and signs the consent form

Exclusion Criteria:

• 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
• Clinically active vaginal or uterine infection
• Maternal HIV, hepatitis C, or hepatitis B
• Uterine scar (including previous cesarean section)
• Condition of the fetus or mother requiring immediate delivery
• Presence of eclampsia
• Severe Pre-eclampsia (Blood pressure ≥160/110 and any of the following: low platelet count (<100 × 10 9/L), HELLP, progressive renal insufficiency, pulmonary edema)
• Severe fetal growth restriction (FGR, fetal growth < -2 SD)
• Estimated fetal weight ≥ 2SD or ≥ 95th percentile
• Breech or transverse fetal position
• Multiple pregnancy
• Vasa previa or placenta previa
• Umbilical cord prolapse
• Maternal refusal to participate in the study and/or insufficient language skills to understand the study information and/or consent form

De-identified individual participant data (IPD) will be made available after study completion. Shared data will include variables necessary to reproduce and analyze catheter performance and safety outcomes, including participant demographics, obstetric history, cervical status, induction outcomes, and adverse events. Data sharing will comply with NIH requirements, participant privacy, and ethical approvals.

The de-identified IPD and supporting information will be available within 12 months from study completion, and will remain available for at least five years.

Researchers may request access to the de-identified data through a data use agreement. Requests will be reviewed to ensure compliance with ethical standards, participant privacy, and funders requirements. Data will be shared via a secure repository or upon reasonable request.