Status:
NOT_YET_RECRUITING
Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction
Lead Sponsor:
Aalto University
Collaborating Sponsors:
University of Mississippi Medical Center
University of Minnesota
Conditions:
Induction of Birth
Cervical Ripening
Eligibility:
FEMALE
18-56 years
Phase:
NA
Brief 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 cathete...
Detailed Description
Screening Phase Before any study-related procedures are initiated, participants will be asked to read and sign the informed consent form. Once consent is obtained, the following screening assessments...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07214948
Start Date
January 5 2026
End Date
October 30 2026
Last Update
October 9 2025
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