Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction
An Open, Parallel-group, Randomized, Early Feasibility Trial to Evaluate the Initial Safety and Performance of the INGA Catheter in Labor Induction
Aalto University
40 participants
Jul 3, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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
Exclusion Criteria20
- 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
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Interventions
Insertion of the INGA balloon catheter (medical device) through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours. After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop \< 6, further management follows
Insertion of a balloon catheter through the cervical canal into the uterus for induction of labor.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07214948