Evaluation of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening (NCT07432282) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
120 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years – 56 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
* Preterm induction of labor (\<37 weeks of gestation)
* Clinical active vaginal or uterine infection
* Abnormal cardiotocography (CTG) at inclusion
* Spontaneous rupture of membranes at inclusion
* 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
* Reduced amniotic fluid volume (deepest vertical pocket \<30 mm)
* Receiving epidural anesthesia prior to catheter insertion
* Refusal to participate in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of successful sensor measurements
Timeframe: During catheter and sensor placement, up to 24 hours