New catheter could make labor induction safer and easier
NCT ID NCT07214948
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This early trial tests a new device called the INGA catheter for inducing labor. It is a balloon that helps soften and open the cervix. The study will compare it to current methods in 40 pregnant women to see if it is safe and works well.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- INGA catheter (single-balloon device for cervical ripening and labor induction)
- What this could lead to
- If it works, this could offer a safer or more comfortable option for inducing labor, potentially reducing complications.
- What could go wrong
- This is a very early feasibility trial with only 40 participants, so results may not apply widely. The device may not perform better than existing methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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12 people
The number who actually took part.
- Started
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Jul 2026
- Finished
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Aug 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 56 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Minnesota Medical School
Minneapolis, Minnesota, 55455, United States
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