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Study of the INGA Catheter for Labor Induction

This study is looking at a new medical device called the INGA catheter for inducing labor. Labor induction is a common procedure, and this study will compare the INGA catheter to a balloon catheter that is already in use. Researchers want to see if the INGA catheter is safe and works well. You might be able to join if you are a pregnant woman between 18 and 56 years old, are at least 37 weeks pregnant with one baby, and have a cervix that is not yet ready for labor (unripe cervix). The main goal is to see how much your cervix changes from when the catheter is put in until it comes out. Feedback will be gathered from both medical staff and participants.

Study design
This is an open, randomized study planning to enroll 40 participants. You would have a 1 in 2 chance of receiving either the INGA catheter or the currently used single balloon catheter.
What's involved
You would undergo screening assessments including medical history, physical exams, and fetal monitoring. If eligible, you would receive one of the study devices for labor induction.
Compensation
Not stated in the trial record.
Follow-up
Your Bishop Score (a measure of cervical readiness) will be assessed from catheter insertion until its detachment.

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NCT07214948

Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction

Recruiting
NAAges 18–56InterventionalTreatment
Aalto University
~40 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:INGA CatheterCurrently used single balloon catheter

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bishop Score Change
Measured over From catheter insertion to detachment

Conditions

Induction of Birth
Cervical Ripening
Cervical Ripening and Induction of Labor

Explore related trials

Induction of Labor

Where it's being run

2 sites across 2 states
Minnesota1
Mississippi1

Study leadership

  • Leena Rahkonen, MD,PhD, Associate Professor · STUDY_CHAIR · Aalto University

Who to contact

Kirsi Roivainen, Master of Health
[email protected]
+358505347653
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Bishop Score ChangeFrom 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.