Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction

Screening Phase

Before any study-related procedures are initiated, participants will be asked to read and sign the informed consent form. Once consent is obtained, the following screening assessments will be performed to determine eligibility for participation:

• Confirmation of informed consent.
• Review of inclusion and exclusion criteria to ensure suitability for the study.
• Collection of medical and demographic information, including medical history, concurrent or previous medications, planned delivery date, gestational age, and indication for labor induction.
• Cervical assessment by palpation.
• Measurement of blood pressure and heart rate.
• Cardiotocography (CTG) monitoring of fetal heart rate and uterine contractions for a minimum of 30 minutes.
• Ultrasound examination within one week prior to induction, to evaluate fetal weight, well-being, and overall status.

If the screening assessments confirm that the participant meets all eligibility criteria, she will proceed to the study phase and receive the assigned study device.

Study Device and Randomization

After signing the informed consent form, each eligible participant will be randomly assigned to one of two treatment groups:

• 1 in 2 chance of receiving the commonly used balloon catheter for labor induction.
• 1 in 2 chance of receiving the INGA catheter, the investigational device being studied.

This is an open-label study, meaning that both the participant and the study personnel (including the investigator and sponsor) will know which device is used.

The study procedure follows the standard clinical process for balloon catheter-based induction of labor. No additional or experimental procedures are performed beyond the use of the assigned catheter. The only difference from routine clinical practice is the use of the INGA catheter in the investigational group.

Study Procedures

Participants will undergo the following procedures as part of the study:

• The catheter (either the standard or INGA catheter) will be inserted by a trained physician through the vagina and advanced through the cervical canal.
• The balloon portion of the catheter will be inflated with sterile saline to secure its position and will be fastened to the inner thigh to maintain placement.
• Fetal heart rate monitoring (CTG) will be performed both before and after catheter placement, following standard hospital protocol.
• Cervical ripeness will be assessed prior to catheter insertion and again after catheter removal or spontaneous expulsion.
• The catheter will remain in place until it detaches spontaneously or for a maximum duration of 24 hours.
• After catheter removal, cervical status will be reassessed, and labor induction will continue according to the hospital's standard of care.

Throughout the procedure, the principal investigator and hospital staff will closely monitor the induction process and ensure the safety and well-being of both the mother and the fetus.

Comprehensive data will be collected on:

• The course of pregnancy and labor induction process.
• Delivery outcomes, including type and duration of delivery.
• Maternal safety data, including any adverse events or complications. Infant Assessments

Following labor and delivery, the following evaluations will be conducted for the newborn:

• Birth weight and length.
• Apgar score at 5 minutes post-delivery.
• Collection of clinical data related to any neonatal diagnoses, treatments, or medical conditions.

Questionnaires

To assess user experience and device tolerability, the following questionnaires will be completed:

• Participants will be asked to complete a short questionnaire evaluating their overall comfort, well-being, and any discomfort or pain experienced during placement and use of the balloon catheter.
• The physician performing the catheter placement will complete a usability questionnaire to assess the practicality, ease of use, and general handling of the device.

Post-Treatment Phase

After completion of the study procedure:

• The study device (INGA catheter or standard catheter) will be used only during this research study and will not be available for use after study participation ends.
• No additional study visits or treatments are required once labor induction and delivery are complete.
• Routine post-delivery care will be provided according to standard hospital practices.

Participant Expectations

By agreeing to participate in this study, each participant is expected to:

• Read, understand, and sign the informed consent document.
• Meet all inclusion criteria and not meet any exclusion criteria.
• Understand that randomization will determine which study device is used.
• Allow collection of maternal and neonatal health data for study analysis.
• Complete the participant questionnaire regarding her experience with the catheter.

Inclusion criteria

• Pregnant women aged ≥18 and ≤56 years
• An unripe cervix, ≤6 points according to the Bishop score assessment (0-10-point scale)
• Planned induction of labor by balloon catheter method
• 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 informed consent

Exclusion criteria

• Preterm induction of labor (<37 weeks of gestation)
• Abnormal Cardiotocography (CTG) at inclusion
• Spontaneous rupture of membranes at inclusion
• Clinically significant vaginal bleeding with a need of hospitalization in the third trimester
• Clinical active vaginal or uterine infection
• Maternal Human Immunodeficiency Virus (HIV), hepatitis C, or hepatitis B
• Uterine scar (including previous cesarean section)
• Condition requiring immediate delivery of the fetus or mother
• Presence of eclampsia
• Severe Preeclampsia [Blood pressure (BP)≥ 160/110 and any of the following: thrombocytopenia with platelet count <100 × 10e9/L, HELLP- syndrome ( Hemolysis, Elevated Liver enzymes and Low Platelets), progressive renal insufficiency, pulmonary edema ]
• Severe fetal growth restriction (Fetal Growth Restriction (FGR) fetal growth <-2 SD/<10th percentile)
• Estimated fetal weight ≥ 2 Standard Deviation /≥ 95th percentile
• Reduced amniotic fluid volume (deepest vertical pocket <30 mill meter)
• Breech or transverse fetal position
• Multiple pregnancy
• Vasa previa or placenta previa
• Umbilical cord prolapses
• Bishop score ≥6 on cervical assessment prior to labor induction
• Receiving epidural anesthesia prior to catheter insertion
• Refusal to participate in the study and/or insufficient language skills to understand the study information and/or consent form