NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)
| NCT ID | NCT07414771 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aalto University |
| Condition | Induction of Labor |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2026-07-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Leena Rahkonen, MD, PhD, Assoc.prof
STUDY CHAIR
Aalto University, INGA Health
Frequently Asked Questions
Who can join the NCT07414771 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 56 Years, studying Induction of Labor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07414771 currently recruiting?
Yes, NCT07414771 is actively recruiting participants. Contact the research team at kirsi.roivainen@mdsfinland.com for enrollment information.
Where is the NCT07414771 trial being conducted?
This trial is being conducted at Helsinki, Finland, Jyväskylä, Finland, Tampere, Finland.
Who is sponsoring the NCT07414771 clinical trial?
NCT07414771 is sponsored by Aalto University. The principal investigator is Leena Rahkonen, MD, PhD, Assoc.prof at Aalto University, INGA Health. The trial plans to enroll 45 participants.