Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)
INGA-MDP
A Medical Device Pilot Study to Evaluate the Safety and Usability of the Inga Catheter in Labor Induction
2 other identifiers
interventional
45
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
May 26, 2026
May 1, 2026
5 months
February 4, 2026
May 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bishop score
The change in Bishop score (on a scale from 0 to 10) during cervical ripening assessed prior to catheter insertion and after catheter detachment
From catheter insertion to detachment
Secondary Outcomes (6)
Successful catheter placement (clinical assessment by investigator)
Periprocedural (at the time of catheter insertion)
Retention time of the balloon catheter
From balloon catheter placement to catheter detachment (up to 24 hours)
Induction to delivery interval
From balloon catheter insertion to delivery of the neonate (assessed up to 48 hours after induction initiation)
Mode of delivery
From enrolment to birth
Patient-reported pain assessment 30 minutes after catheter insertion
Within 60 minutes after catheter insertion
- +1 more secondary outcomes
Study Arms (1)
INGA catheter for cervical ripening
EXPERIMENTALParticipants in this arm will undergo cervical ripening using the INGA cervical ripening balloon catheter as part of labor induction. The catheter is inserted into the cervix and filled with saline according to the device instructions. The balloon may remain in place for up to 24 hours unless expelled spontaneously earlier. Cervical status is assessed before and after catheter use using the Bishop score. Participants will receive standard obstetric care throughout labor induction and labor. Data on device usability, insertion experience, pain, retention time, and delivery outcomes will be collected. Participants and healthcare professionals involved in the procedure will also provide feedback on catheter performance and usability.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Preterm induction of labor (\<37 weeks of gestation)
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitalcollaborator
- Aalto Universitylead
- Tampere University Hospitalcollaborator
- Jyväskylä Central Hospitalcollaborator
Study Sites (3)
Helsinki University Hospital
Helsinki, HUS, 00029, Finland
Hospital Nova
Jyväskylä, 40620, Finland
Tampere University Hospital
Tampere, 33101, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Leena Rahkonen, MD, PhD, Assoc.prof
Aalto University, INGA Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 17, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
May 26, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The de-identified IPD and supporting information will be available within 12 months from study completion, and will remain available for at least five years.
- Access Criteria
- Researchers may request access to the de-identified data through a data use agreement. Requests will be reviewed to ensure compliance with ethical standards, participant privacy, and funders requirements. Data will be shared via a secure repository or upon reasonable request.
De-identified individual participant data (IPD) will be made available after study completion. Shared data will include variables necessary to reproduce and analyze catheter performance and safety outcomes, including participant demographics, obstetric history, cervical status, induction outcomes, and adverse events. Data sharing will comply with NIH requirements, participant privacy, and ethical approvals.