Evaluation of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Starting soon · Not applicable
Conditions studied: Induction of Birth, Cervical Ripening, Cervical Ripening and Induction of Labor, Balloon Catheter for Labor Induction
In brief
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.
Key facts
- Study ID
- NCT07432282
- Run by
- Aalto University
- People needed
- 120
- Starts
- 2026-08-01
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older, up to 56. Sex: female. Healthy volunteers: not accepted.
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
- 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 the study and/or insufficient language skills to understand the study information and/or consent form
Full record on ClinicalTrials.gov
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