Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening

NCT07846111 | Not Yet Recruiting

• 2 other identifiers: CIV-EE-26-08-059575.240023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the safety and performance of the INGA Sensor System when used with the INGA balloon catheter during cervical ripening for labor induction in pregnant individuals at term. Cervical ripening is a process used to prepare the cervix for labor. The main questions it aims to answer are:

• Is the INGA Sensor System safe to use during cervical ripening with the INGA balloon catheter?
• How well does the sensor system measure uterine contractions and fetal heart rate during cervical ripening?
• How does the use of the INGA balloon catheter affect cervical ripening and the time from induction to delivery?
• How do participants and healthcare professionals evaluate the usability of the catheter and sensor system? All participants in this study will receive the INGA balloon catheter with the attached sensor system. There is no comparison group. Participants will:
• Undergo routine assessments before labor induction, including medical history review, cervical examination, blood pressure and heart rate measurement, and fetal heart rate monitoring
• Have the INGA balloon catheter placed in the cervix by a trained physician
• Have a small sensor device attached to the external end of the catheter
• Undergo standard fetal heart rate monitoring after placement
• Keep the catheter and sensor in place until the catheter is expelled naturally or for up to 24 hours
• Continue labor induction and delivery according to standard hospital practice
• Complete a questionnaire about comfort and usability
• Allow collection of information about labor, delivery, and newborn outcomes from medical records Participation lasts from signing informed consent until hospital discharge.

Conditions

Induced Labor; Cervical Ripening; Cervical Ripening and Induction of Labor; Balloon Catheter for Labor Induction

Keywords

Cervical ripening; Induction of labor; Balloon catheter; Fetal monitoring; Uterine monitoring

Outcome Measures

Primary Outcomes (1)

• Proportion of successful sensor measurements

  Proportion (%) of successful sensor measurements out of all measurement attempts. A successful measurement is defined as a sensor reading that provides clinically interpretable fetal heart rate and/or uterine contraction data for at least 10 consecutive minutes.

  During catheter and sensor placement, up to 24 hours

Secondary Outcomes (14)

• Patient-reported assessment of pain

  Periprocedurally

• Patient-reported experience of the device use

  Periprocedurally

• Healthcare professionals' experience of catheter usability

  Periprocedurally (after catheter and sensor placement)

• Health care professional's experience on the sensor usability

  Periprocedurally (after catheter and sensor placement)

• Adverse events and safety

  Through study completion, an average of 4 days.

Study Arms (1)

INGA Sensor

EXPERIMENTAL

Participants in this single study arm will undergo cervical ripening using the INGA balloon catheter with the attached INGA sensor during labor induction. The catheter is inserted vaginally through the cervical canal so that the balloon tip is positioned between the amniotic membranes and the internal cervical os. The balloon is inflated with 50-75 mL of sterile saline and the external end is secured to the inner thigh. The INGA sensor is attached to the external portion of the catheter and records maternal and fetal data, such as heart rate and uterine contractions. Clinical monitoring is performed according to hospital guidelines. CTG monitoring is conducted for at least 60 minutes after placement. The sensor remains in place until catheter detachment or up to 24 hours.

Device: Cervical ripening, labor Induction, uterus and fetal monitoring

Interventions

Cervical ripening, labor Induction, uterus and fetal monitoring DEVICE

INGA balloon catheter mounted sensor system will be used for cervical ripening during labor induction. The data on sensor usability, registration of fetal and maternal heart activity, fetal movements and uterine contractions will be obtained. The INGA catheter insertion experience, patient pain, retention time, and delivery outcomes, as well as feedback from both participants and healthcare professionals regarding device performance and usability will be collected.

INGA Sensor

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged ≥18 and ≤56 years
• An unripe cervix, see below
• Planned induction of labor by mechanical balloon catheter method
• Gestational age at the time of the study ≥ 37 weeks
• Singleton pregnancy
• Cephalic presentation
• The subject understands the study information and signs the informed consent

You may not qualify if:

• Preterm induction of labor (\<37 weeks of gestation)
• Clinical active vaginal or uterine infection
• Clinically significant vaginal bleeding with need of hospitalization in the third trimester
• Maternal HIV, hepatitis C, or hepatitis B
• Condition of the fetus or mother requiring immediate delivery
• Presence of eclampsia
• Severe Preeclampsia (Blood pressure ≥160/110 and any of the following: HELLP (Hemolysis, Elevated Liver enzymes, and Low Platelet count \<100 × 10 9/L syndrome), progressive renal insufficiency, pulmonary edema)
• Severe fetal growth restriction (FGR, growth \< -2 SD/\<10th percentile)
• Estimated fetal weight ≥ 2SD or ≥ 95th percentile
• Breech or transverse fetal position
• Multiple pregnancy
• Vasa previa or placenta previa
• Uterine scar (including previous caesarean section)
• Umbilical cord prolapse
• Bishop score ≥6 on cervical assessment prior to labor induction

Sponsors & Collaborators

• Aalto University: lead
• West Tallinn Central Hospital: collaborator

Study Sites (1)

West-Tallinn Central Hospital Women's Clinic (AS Lääne-Tallinna Keskhaigla naistekliinik/Pelgulinna Sünnitusmaja)

Tallinn, 10614, Estonia

Location

MeSH Terms

Interventions

Labor, Induced; Fetal Monitoring

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• Leena Rahkonen, MD, PhD, Associate professor

  Aalto University

  STUDY CHAIR

Central Study Contacts

Alena Lokteva

CONTACT

+358413100927; alena@mdsfinland.com

Heidi Kruit, MD, PhD, Associate professor

CONTACT

+358504284685; heidi.kruit@aalto.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 29, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

ES (1)