Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) (NCT07414771) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)
Finland45 participantsStarted 2026-05
Plain-language summary
The goal of this clinical study is to evaluate a new mechanical balloon catheter (INGA) used to prepare the cervix for labor induction in pregnant women at term.
The study aims to assess the safety, usability, and performance of the INGA catheter when used for cervical ripening before labor. Researchers will also collect feedback from healthcare professionals and participants about the use of the device.
Participants are pregnant women at term with a single baby in a head-down position who meet the study eligibility criteria.
Participants will:
* have the INGA balloon catheter inserted as part of labor induction,
* receive standard clinical care according to hospital practice,
* provide information about their experience and outcomes related to the device.
The results of this study will help determine whether the INGA catheter is safe and suitable for use in cervical ripening during labor induction.
Who can participate
Age range
18 Years – 56 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.