Induction of BirthINGA-RCTNCT07214948
Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction
A study testing INGA Catheter and Currently used single balloon catheter in people with Induction of Birth and Cervical Ripening, run by Aalto University at 1 site in United States.
Trial summary
This study investigates the safety and usability of the new INGA catheter for labor induction. Labor induction is common, with about one in three births being induced. In this study, the INGA catheter will be compared to a currently used method. Read more about this study
- Who is it for?
- Ages 18 to 56 years, women only
- Conditions the study is for
- Induction of Birth, Cervical Ripening, Cervical Ripening and Induction of Labor
- What is being tested?
- INGA Catheter and Currently used single balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 56 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged ≥18 and ≤56 years
- An unripe cervix, ≤6 points according to the Bishop score assessment (0-10-point scale)
- Planned induction of labor by balloon catheter method
- 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 informed consent
Who cannot join
- Preterm induction of labor (<37 weeks of gestation)
- Abnormal Cardiotocography (CTG) at inclusion
- Spontaneous rupture of membranes at inclusion
- Clinically significant vaginal bleeding with a need of hospitalization in the third trimester
- Clinical active vaginal or uterine infection
- Maternal Human Immunodeficiency Virus (HIV), hepatitis C, or hepatitis B
Show all 20Show fewer
- Uterine scar (including previous cesarean section)
- Condition requiring immediate delivery of the fetus or mother
- Presence of eclampsia
- Severe Preeclampsia [Blood pressure (BP)≥ 160/110 and any of the following: thrombocytopenia with platelet count <100 × 10e9/L, HELLP- syndrome ( Hemolysis, Elevated Liver enzymes and Low Platelets), progressive renal insufficiency, pulmonary edema ]
- Severe fetal growth restriction (Fetal Growth Restriction (FGR) fetal growth <-2 SD/<10th percentile)
- Estimated fetal weight ≥ 2 Standard Deviation /≥ 95th percentile
- Reduced amniotic fluid volume (deepest vertical pocket <30 mill meter)
- Breech or transverse fetal position
- Multiple pregnancy
- Vasa previa or placenta previa
- Umbilical cord prolapses
- Bishop score ≥6 on cervical assessment prior to labor induction
- Receiving epidural anesthesia prior to catheter insertion
- Refusal to participate in the study and/or insufficient language skills to understand the study information and/or consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
About this study
Official title: An Open, Parallel-group, Randomized, Early Feasibility Trial to Evaluate the Initial Safety and Performance of the INGA Catheter in Labor Induction
This study investigates the safety and usability of the new INGA catheter for labor induction.
Labor induction is common, with about one in three births being induced. In this study, the INGA catheter will be compared to a currently used method. The INGA catheter is a single-balloon device that works similarly to a Foley catheter but is made from different materials. Feedback will be collected from both healthcare professionals and participating women.
Read the detailed description
Screening Phase
Before any study-related procedures are initiated, participants will be asked to read and sign the informed consent form. Once consent is obtained, the following screening assessments will be performed to determine eligibility for participation:
- Confirmation of informed consent.
- Review of inclusion and exclusion criteria to ensure suitability for the study.
- Collection of medical and demographic information, including medical history, concurrent or previous medications, planned delivery date, gestational age, and indication for labor induction.
- Cervical assessment by palpation.
- Measurement of blood pressure and heart rate.
- Cardiotocography (CTG) monitoring of fetal heart rate and uterine contractions for a minimum of 30 minutes.
- Ultrasound examination within one week prior to induction, to evaluate fetal weight, well-being, and overall status.
If the screening assessments confirm that the participant meets all eligibility criteria, she will proceed to the study phase and receive the assigned study device.
Study Device and Randomization
After signing the informed consent form, each eligible participant will be randomly assigned to one of two treatment groups:
- 1 in 2 chance of receiving the commonly used balloon catheter for labor induction.
- 1 in 2 chance of receiving the INGA catheter, the investigational device being studied.
This is an open-label study, meaning that both the participant and the study personnel (including the investigator and sponsor) will know which device is used.
The study procedure follows the standard clinical process for balloon catheter-based induction of labor. No additional or experimental procedures are performed beyond the use of the assigned catheter. The only difference from routine clinical practice is the use of the INGA catheter in the investigational group.
Study Procedures
Participants will undergo the following procedures as part of the study:
- The catheter (either the standard or INGA catheter) will be inserted by a trained physician through the vagina and advanced through the cervical canal.
- The balloon portion of the catheter will be inflated with sterile saline to secure its position and will be fastened to the inner thigh to maintain placement.
- Fetal heart rate monitoring (CTG) will be performed both before and after catheter placement, following standard hospital protocol.
- Cervical ripeness will be assessed prior to catheter insertion and again after catheter removal or spontaneous expulsion.
- The catheter will remain in place until it detaches spontaneously or for a maximum duration of 24 hours.
- After catheter removal, cervical status will be reassessed, and labor induction will continue according to the hospital's standard of care.
Throughout the procedure, the principal investigator and hospital staff will closely monitor the induction process and ensure the safety and well-being of both the mother and the fetus.
Comprehensive data will be collected on:
- The course of pregnancy and labor induction process.
- Delivery outcomes, including type and duration of delivery.
- Maternal safety data, including any adverse events or complications. Infant Assessments
Following labor and delivery, the following evaluations will be conducted for the newborn:
- Birth weight and length.
- Apgar score at 5 minutes post-delivery.
- Collection of clinical data related to any neonatal diagnoses, treatments, or medical conditions.
Questionnaires
To assess user experience and device tolerability, the following questionnaires will be completed:
- Participants will be asked to complete a short questionnaire evaluating their overall comfort, well-being, and any discomfort or pain experienced during placement and use of the balloon catheter.
- The physician performing the catheter placement will complete a usability questionnaire to assess the practicality, ease of use, and general handling of the device.
Post-Treatment Phase
After completion of the study procedure:
- The study device (INGA catheter or standard catheter) will be used only during this research study and will not be available for use after study participation ends.
- No additional study visits or treatments are required once labor induction and delivery are complete.
- Routine post-delivery care will be provided according to standard hospital practices.
Participant Expectations
By agreeing to participate in this study, each participant is expected to:
- Read, understand, and sign the informed consent document.
- Meet all inclusion criteria and not meet any exclusion criteria.
- Understand that randomization will determine which study device is used.
- Allow collection of maternal and neonatal health data for study analysis.
- Complete the participant questionnaire regarding her experience with the catheter.
- Being tested
- INGA Catheter, Currently used single balloon catheter
- Keywords
- Induction of labor, Balloon Catheter, Cervical ripening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INGA CatheterDevice
Insertion of the INGA balloon catheter (medical device) through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours.
After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop < 6, further management follows
Currently used single balloon catheterDevice
Insertion of a balloon catheter through the cervical canal into the uterus for induction of labor.
| Study group | Role | What they receive |
|---|---|---|
| INGA Catheter | Experimental | Description: Insertion of the INGA balloon catheter (medical device) through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours. After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop < 6, further management follows Receives: Device: INGA Catheter |
| Currently used induction catheter | Other | Insertion of the currently used induction balloon catheter through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours.
After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop < 6, further management follows Receives: Device: Currently used single balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bishop Score Change
Change in Bishop score (A scale from 1 to 10) during cervical ripening, with scores assessed before catheter insertion and after catheter detachment.
Measured: From catheter insertion to detachment
Secondary outcomes (6)
Placement success
Whether the catheter is placed successfully
Measured: At catheter insertion
Retention time of balloon catheter
The time the balloon catheter remains in the cervix for cervical ripening
Measured: From catheter placement to detachment, 0-24 hours
Induction to delivery interval
Time from initiation of labor induction (balloon catheter insertion) to the delivery of the neonate. This includes both the cervical ripening phase and active labor. The outcome will capture the total duration of the induction-to-delivery process.
Measured: rom the start of balloon catheter insertion until the birth of the neonate, 0-48 hours
Mode of delivery
The type of delivery for the participant, categorized as vaginal, vaginal operative or cesarean delivery
Measured: From enrolment to birth
Pain experience during catheter insertion and in-place time
The participants will complete a structured questionnaire to assess any potential pain experienced during catheter placement and retention
Measured: Within 60 minutes from catheter insertion
Professional's experience of catheter insertion and usability
The Investigators will complete a structured questionnaire to evaluate the ease of catheter placement, usability, quality, appearance, and balloon inflation. The questionnaire also includes questions regarding their willingness to use technological applications in the context of labor induction.
Measured: From catheter insertion to detachment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start3 Jul 2026
- Primary completion25 Aug 2026
- Study completion31 Aug 2026
Why it stopped: The study was terminated prematurely because the funder discontinued financial support for the study. The decision was not based on safety concerns or study results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalto University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mississippi Medical Center, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Leena Rahkonen, MD,PhD, Associate Professor, Study chair, Aalto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214948
- Sponsor's protocol ID
- Pro00089090
- Other IDs
- ARPA-H-ICHUB-24-101-1675/SWH-2
- Acronym
- INGA-RCT
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Parallel-group, Randomized, Early Feasibility Trial to Evaluate the Initial Safety and Performance of the INGA Catheter in Labor Induction
- ClinicalTrials.gov ID
- NCT07214948
- Acronym / sponsor ID
- INGA-RCT / Pro00089090
- Keywords
- Induction of labor, Balloon Catheter, Cervical ripening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely because the funder discontinued financial support for the study. The decision was not based on safety concerns or study results.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aalto UniversityUniversity, hospital or other
- Collaborators
- University of Mississippi Medical Center, University of Minnesota
- Study start
- 3 Jul 2026 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the safety and usability of the new INGA catheter for labor induction.
Labor induction is common, with about one in three births being induced. In this study, the INGA catheter will be compared to a currently used method. The INGA catheter is a single-balloon device that works similarly to a Foley catheter but is made from different materials. Feedback will be collected from both healthcare professionals and participating women.
Detailed description
Screening Phase
Before any study-related procedures are initiated, participants will be asked to read and sign the informed consent form. Once consent is obtained, the following screening assessments will be performed to determine eligibility for participation:
- Confirmation of informed consent.
- Review of inclusion and exclusion criteria to ensure suitability for the study.
- Collection of medical and demographic information, including medical history, concurrent or previous medications, planned delivery date, gestational age, and indication for labor induction.
- Cervical assessment by palpation.
- Measurement of blood pressure and heart rate.
- Cardiotocography (CTG) monitoring of fetal heart rate and uterine contractions for a minimum of 30 minutes.
- Ultrasound examination within one week prior to induction, to evaluate fetal weight, well-being, and overall status.
If the screening assessments confirm that the participant meets all eligibility criteria, she will proceed to the study phase and receive the assigned study device.
Study Device and Randomization
After signing the informed consent form, each eligible participant will be randomly assigned to one of two treatment groups:
- 1 in 2 chance of receiving the commonly used balloon catheter for labor induction.
- 1 in 2 chance of receiving the INGA catheter, the investigational device being studied.
This is an open-label study, meaning that both the participant and the study personnel (including the investigator and sponsor) will know which device is used.
The study procedure follows the standard clinical process for balloon catheter-based induction of labor. No additional or experimental procedures are performed beyond the use of the assigned catheter. The only difference from routine clinical practice is the use of the INGA catheter in the investigational group.
Study Procedures
Participants will undergo the following procedures as part of the study:
- The catheter (either the standard or INGA catheter) will be inserted by a trained physician through the vagina and advanced through the cervical canal.
- The balloon portion of the catheter will be inflated with sterile saline to secure its position and will be fastened to the inner thigh to maintain placement.
- Fetal heart rate monitoring (CTG) will be performed both before and after catheter placement, following standard hospital protocol.
- Cervical ripeness will be assessed prior to catheter insertion and again after catheter removal or spontaneous expulsion.
- The catheter will remain in place until it detaches spontaneously or for a maximum duration of 24 hours.
- After catheter removal, cervical status will be reassessed, and labor induction will continue according to the hospital's standard of care.
Throughout the procedure, the principal investigator and hospital staff will closely monitor the induction process and ensure the safety and well-being of both the mother and the fetus.
Comprehensive data will be collected on:
- The course of pregnancy and labor induction process.
- Delivery outcomes, including type and duration of delivery.
- Maternal safety data, including any adverse events or complications. Infant Assessments
Following labor and delivery, the following evaluations will be conducted for the newborn:
- Birth weight and length.
- Apgar score at 5 minutes post-delivery.
- Collection of clinical data related to any neonatal diagnoses, treatments, or medical conditions.
Questionnaires
To assess user experience and device tolerability, the following questionnaires will be completed:
- Participants will be asked to complete a short questionnaire evaluating their overall comfort, well-being, and any discomfort or pain experienced during placement and use of the balloon catheter.
- The physician performing the catheter placement will complete a usability questionnaire to assess the practicality, ease of use, and general handling of the device.
Post-Treatment Phase
After completion of the study procedure:
- The study device (INGA catheter or standard catheter) will be used only during this research study and will not be available for use after study participation ends.
- No additional study visits or treatments are required once labor induction and delivery are complete.
- Routine post-delivery care will be provided according to standard hospital practices.
Participant Expectations
By agreeing to participate in this study, each participant is expected to:
- Read, understand, and sign the informed consent document.
- Meet all inclusion criteria and not meet any exclusion criteria.
- Understand that randomization will determine which study device is used.
- Allow collection of maternal and neonatal health data for study analysis.
- Complete the participant questionnaire regarding her experience with the catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INGA Catheter | Experimental | Device: INGA CatheterDescription: Insertion of the INGA balloon catheter (medical device) through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours. After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop < 6, further management follows |
| Currently used induction catheter | Other | Device: Currently used single balloon catheterInsertion of the currently used induction balloon catheter through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours. After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop < 6, further management follows |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women aged ≥18 and ≤56 years
- An unripe cervix, ≤6 points according to the Bishop score assessment (0-10-point scale)
- Planned induction of labor by balloon catheter method
- Gestational age at the time of the study ≥ 37 weeks (gestational age confirmed by ultrasound before the 21st week of pregnancy)
- Singleton pregnancy
Key exclusion criteria (20 listed)
- Preterm induction of labor (<37 weeks of gestation)
- Abnormal Cardiotocography (CTG) at inclusion
- Spontaneous rupture of membranes at inclusion
- Clinically significant vaginal bleeding with a need of hospitalization in the third trimester
- Clinical active vaginal or uterine infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INGA CatheterInsertion of the INGA balloon catheter (medical device) through the cervical canal into the uterus is performed for labor induction. During a vaginal examination, the Investigator inserts the catheter so that the balloon tip lies between the amniotic membranes and the internal cervical os. The balloon is filled with 50-75 ml of sterile saline (NaCl) and secured to the upper thigh to maintain gentle traction. The catheter remains in place for up to 24 hours or until spontaneous expulsion. If not expelled, it is removed after 24 hours. After expulsion or removal, cervical status and Bishop score are assessed. If Bishop ≥ 6, amniotomy and/or oxytocin induction are initiated within one hour. If Bishop < 6, further management follows | Device | INGA Catheter |
| Currently used single balloon catheterInsertion of a balloon catheter through the cervical canal into the uterus for induction of labor. | Device | Currently used induction catheter |
Primary outcome
Bishop Score Change
Time frame: From catheter insertion to detachment
Change in Bishop score (A scale from 1 to 10) during cervical ripening, with scores assessed before catheter insertion and after catheter detachment.
6 secondary outcomes
Placement success
Time frame: At catheter insertion
Retention time of balloon catheter
Time frame: From catheter placement to detachment, 0-24 hours
Induction to delivery interval
Time frame: rom the start of balloon catheter insertion until the birth of the neonate, 0-48 hours
Mode of delivery
Time frame: From enrolment to birth
Pain experience during catheter insertion and in-place time
Time frame: Within 60 minutes from catheter insertion
Professional's experience of catheter insertion and usability
Time frame: From catheter insertion to detachment
Results and safety
The study was stopped early (reason given: The study was terminated prematurely because the funder discontinued financial support for the study. The decision was not based on safety concerns or study results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leena Rahkonen, MD,PhD, Associate Professor study chair
Aalto University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INGA Catheter and Currently used single balloon catheter in people with Induction of Birth and Cervical Ripening, run by Aalto University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated prematurely because the funder discontinued financial support for the study. The decision was not based on safety concerns or study results.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bishop Score Change (time frame: From catheter insertion to detachment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.