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

NCT07432282 | Not Yet Recruiting FDA Device

• 2 other identifiers: Pro00092879ARPA-H-ICHUB-24-101-1675/SWH-2
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

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

Keywords

Induction of labour; Balloon Catheter; Cervical Ripening; Uterine monitoring; Fetal 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 (12)

• Healthcare professionals' experience of device usability

  Periprocedural (after catheter and sensor placement)

• Patient Experience of Device Use

  Immediately after catheter and sensor placement, before hospital discharge

• Adverse Events and Safety

  rom catheter and sensor insertion until hospital discharge, with adverse events monitored for up to 24 hours after catheter removal or expulsion.

• Signal Quality Assessment

  During catheter and sensor placement, up to 24 hours

• Device Malfunctions

  During catheter and sensor placement, up to 24 hours

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 sensor with INGA Induction Catheter. The trial systematically collects data on sensor usability, registration of fetal and maternal heart activity and uterine contractions, 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.

INGA Sensor

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: female
• Healthy Volunteers: No
• 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 requiring immediate delivery of the fetus or mother
• 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
• University of Mississippi Medical Center: collaborator
• University of Minnesota: collaborator

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

Kirsi Roivainen, Master of Health

CONTACT

+358505347673; kirsi.roivainen@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: February 10, 2026
• First Posted: February 25, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02