Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)
A Medical Device Pilot Study to Evaluate the Safety and Usability of the Inga Catheter in Labor Induction
Aalto University
45 participants
Jul 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria15
- 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 Criteria17
- 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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Interventions
This study uses the INGA cervical ripening balloon catheter for labor induction, with standardized insertion and saline filling according to device instructions, allowing the balloon to remain in place up to 24 hours. The trial systematically collects data on catheter usability, insertion experience, patient pain, retention time, and delivery outcomes, as well as feedback from both participants and healthcare professionals regarding device performance and usability. Cervical status is evaluated using the Bishop score before and after catheter use.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07414771