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New catheter could make labor induction safer and easier

NCT ID NCT07214948

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

12 people

The number who actually took part.

Started

Jul 2026

Finished

Aug 2026

Lead sponsor

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

18 to 56 years

Sex

Female participants only

Healthy volunteers

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

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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Minnesota Medical School

    Minneapolis, Minnesota, 55455, United States

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