Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction
Recruiting now · Not applicable
Conditions studied: Induction of Birth, Cervical Ripening, Cervical Ripening and Induction of Labor
In brief
This study investigates the safety and usability of the new INGA catheter for labor induction. Labor induction is common, with about one in three births being induced. In this study, the INGA catheter will be compared to a currently used method. The INGA catheter is a single-balloon device that works similarly to a Foley catheter but is made from different materials. Feedback will be collected from both healthcare professionals and participating women.
Key facts
- Study ID
- NCT07214948
- Run by
- Aalto University
- People needed
- 40
- Starts
- 2026-07-03
- Expected to finish
- 2026-10-30
- 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, ≤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
You may not qualify if…
- 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
Where it is running
- University of Minnesota Medical School — Minneapolis, Minnesota, United States (enrolling)
- University of Mississippi Medical Center — Jackson, Mississippi, United States
Full record on ClinicalTrials.gov
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