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New catheter aims to make labor induction easier and safer
NCT ID NCT07414771
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
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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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42 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 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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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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Helsinki University Hospital
Helsinki, HUS, 00029, Finland
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Hospital Nova
Jyväskylä, 40620, Finland
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Tampere University Hospital
Tampere, 33101, Finland
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