NCT07214948 · Aalto University
Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction
(INGA-RCT)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
INGA Catheter
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
DEVICE
Currently used single balloon catheter
Insertion of a balloon catheter through the cervical canal into the uterus for induction of labor.
Primary outcome measures
Bishop Score Change
Time frame: From catheter insertion to detachment
Change in Bishop score (A scale from 1 to 10) during cervical ripening, with scores assessed before catheter insertion and after catheter detachment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- Minneapolis, Minnesota
- Jackson, Mississippi
Collaborators
University of Mississippi Medical Center, University of Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 22, 2026 · Source of record for eligibility and locations