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New catheter aims to make labor induction easier and safer

NCT ID NCT07414771

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This pilot study tests a new medical device called the INGA catheter, a balloon used to prepare the cervix for labor induction in pregnant women at term. Researchers will check if it is safe and easy to use, and gather feedback from patients and doctors. The study involves 45 women with a single baby in head-down position.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INGA cervical ripening balloon catheter
What this could lead to
If successful, this device could offer a safe and easy-to-use option for preparing the cervix before labor induction.
What could go wrong
This is a small, early pilot study with only 45 participants, so results may not apply to all women. The device may not work 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

42 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 assessment (0-10 point scale) * Planned induction of labor by mechanical balloon catheter method * Examples of diagnoses as the basis for labor induction: * Post-term pregnancy (≥41 weeks of gestation) * Maternal request for labor induction * Gestational diabetes * Preeclampsia (with blood pressure \<150/100) * Well-controlled hypertension * Cholestasis of pregnancy * Humanitarian or psychosocial reasons * 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 consent form Exclusion Criteria: * Preterm induction of labor (\<37 weeks of gestation) * Pathological CTG at inclusion * Spontaneous rupture of membranes at inclusion * Clinically significant vaginal bleeding with need of hospitalization in the third trimester * Clinically active vaginal or uterine infection * Maternal HIV, hepatitis C, or hepatitis B * Uterine scar (including previous cesarean section) * Condition of the fetus or mother requiring immediate delivery * Presence of eclampsia * Severe Pre-eclampsia (Blood pressure ≥160/110 and any of the following: low platelet count (\<100 × 10 9/L), HELLP, progressive renal insufficiency, pulmonary edema) * Severe fetal growth restriction (FGR, fetal growth \< -2 SD) * Estimated fetal weight ≥ 2SD or ≥ 95th percentile * Breech or transverse fetal position * Multiple pregnancy * Vasa previa or placenta previa * Umbilical cord prolapse * Maternal 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

  • Helsinki University Hospital

    Helsinki, HUS, 00029, Finland

  • Hospital Nova

    Jyväskylä, 40620, Finland

  • Tampere University Hospital

    Tampere, 33101, Finland

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