Induction of LaborINGA-MDPNCT07414771
Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)
A study testing Cervical ripening, labor induction in people with Induction of Labor and Cervical Ripening, run by Aalto University at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 56 years, women only
- Conditions the study is for
- Induction of Labor, Cervical Ripening, Cervical Ripening and Induction of Labor
- What is being tested?
- Cervical ripening, labor induction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesFinland
- Study dates
- 1 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 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
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- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Hospital
Helsinki, HUS, 00029
Hospital Nova
Jyväskylä, 40620
Tampere University Hospital
Tampere, 33101
About this study
Official title: A Medical Device Pilot Study to Evaluate the Safety and Usability of the Inga Catheter in Labor Induction
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.
Read more
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.
Read the detailed description
This prospective, single-arm clinical investigation evaluates the safety, usability, performance, and preliminary efficacy of the INGA mechanical cervical ripening balloon catheter when used for induction of labor at term. The study is conducted as a medical device investigation in accordance with the Declaration of Helsinki, ICH-GCP principles, and applicable regulatory and ethical requirements. All participants provide written informed consent prior to participation. Mechanical cervical ripening is an established method for labor induction, particularly in women with an unfavorable cervix. Balloon catheters promote cervical ripening through direct mechanical dilation and stimulation of endogenous prostaglandin release, offering a non-pharmacological alternative to pharmacologic methods.
The INGA catheter is a single-use mechanical single-balloon device intended for placement between the fetal membranes and the internal cervical os during a vaginal examination. After insertion, the balloon is filled with sterile saline according to the device instructions for use and maintained under gentle traction. The device may remain in place for up to 24 hours or until spontaneous detachment. Cervical status is assessed prior to catheter insertion and following catheter detachment or removal, and further induction management, including amniotomy and/or oxytocin administration, is performed according to routine clinical practice. Outpatient cervical ripening may be permitted for selected participants based on predefined clinical criteria and local hospital practice.
The study enrolls approximately 30-50 pregnant women at ≥37 weeks of gestation with a singleton pregnancy in cephalic presentation and an unfavorable cervix (Bishop score ≤6) for whom induction of labor has been clinically indicated. Both nulliparous and multiparous women may participate. After providing written informed consent and confirmation of eligibility, participants undergo cervical ripening with the INGA catheter as part of standard induction care. The study does not include a comparison group.
The study collects clinical data during cervical ripening, labor, and delivery in order to characterize device performance in a real-world hospital setting. In addition to clinical outcomes, the investigation includes structured assessments of user experience. Participating women complete questionnaires regarding pain and overall experience related to catheter placement and retention. Healthcare professionals complete structured usability evaluations addressing ease of insertion, handling characteristics, and overall device performance.
Clinical data are collected during cervical ripening, labor, and delivery to characterize device performance in a real-world hospital setting. In addition to clinical outcomes, structured user-reported data are obtained. Participating women complete questionnaires addressing pain and overall experience during catheter placement and retention. Healthcare professionals complete structured evaluations of device usability, ease of insertion, handling characteristics, and overall performance.
Safety is assessed throughout cervical ripening and delivery by systematic monitoring and documentation of adverse events and device-related incidents in accordance with regulatory requirements. As an exploratory pilot investigation, the study is intended to generate preliminary clinical data to support further clinical development and future confirmatory studies.
- Being tested
- Cervical ripening, labor induction
- Keywords
- Cervical ripening, Balloon catheter, Induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical ripening, labor inductionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| INGA catheter for cervical ripening | Experimental | Participants 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. Receives: Device: Cervical ripening, labor induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From catheter insertion to detachment
Secondary outcomes (6)
Successful catheter placement (clinical assessment by investigator)
Successful placement defined as correct intrauterine positioning of the catheter as confirmed clinically by the inserting healthcare professional at the time of insertion.
Measured: Periprocedural (at the time of catheter insertion)
Retention time of the balloon catheter
Duration (in hours) that the balloon catheter remains in place in the cervix for cervical ripening.
Measured: From balloon catheter placement to catheter detachment (up to 24 hours)
Induction to delivery interval
Time (in hours) from initiation of labor induction (balloon catheter insertion) to delivery of the neonate. This includes both the cervical ripening phase and active labor.
Measured: From balloon catheter insertion to delivery of the neonate (assessed up to 48 hours after induction initiation)
Mode of delivery
The type of delivery for the participant, categorized as vaginal delivery, instrumental vaginal delivery, or cesarean section.
Measured: From enrolment to birth
Patient-reported pain assessment 30 minutes after catheter insertion
Composite patient-reported assessment of pain collected using a structured study-specific questionnaire 30 minutes after catheter insertion, including:
- Pain intensity measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain (higher scores indicate greater pain)
- Pain tolerability (yes/no)
- Pain characteristics (categorical: sharp, burning, stabbing, throbbing, cramping, pressure, other)
- Pain duration (categorical: brief moment, few minutes, longer than 30 minutes, other)
- Pain location (categorical: abdominal area, back, vagina, external genitals, other)
Measured: Within 60 minutes after catheter insertion
Professionals' experience of insertion and catheter usability
Description: Composite health care professional reported assessment of catheter usability collected using a structured study-specific questionnaire immediately after catheter insertion to evaluate the following:
Ease of catheter placement (Likert Scale, 1 = very difficult, 5 = very easy; higher scores indicate easier placement) Catheter usability (Likert Scale, 1 = poor, 5 = excellent; higher scores indicate better usability) Quality and appearance of the catheter (Likert Scale, 1 = poor, 5 = excellent; higher scores indicate better quality/appearance) Balloon inflation (Likert Scale, 1 = poor, 5 = excellent; higher scores indicate better inflation) Willingness to use technological applications in labor induction (Yes/No)
Measured: Periprocedural (after catheter insertion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 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 LaborStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A non-randomized, single-arm pilot study of a mechanical cervical ripening device that focuses on usability and performance outcomes and does not include a comparison group.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalto University
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Jyväskylä Central Hospital, Helsinki University Central Hospital
- Responsible party
- Sponsor
- Investigators
- Leena Rahkonen, MD, PhD, Assoc.prof, Study chair, Aalto University, INGA Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414771
- Sponsor's protocol ID
- HUS/451/2025
- Other IDs
- ARPA-H-ICHUB-24-101-1675/SWH-2
- Acronym
- INGA-MDP
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
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
- A Medical Device Pilot Study to Evaluate the Safety and Usability of the Inga Catheter in Labor Induction
- ClinicalTrials.gov ID
- NCT07414771
- Acronym / sponsor ID
- INGA-MDP / HUS/451/2025
- Keywords
- Cervical ripening, Balloon catheter, Induction of labor
- 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
- 42 participants (actual)
- Lead sponsor
- Aalto UniversityUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Jyväskylä Central Hospital, Helsinki University Central Hospital
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 17 Feb 2026 (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.
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.
Detailed description
This prospective, single-arm clinical investigation evaluates the safety, usability, performance, and preliminary efficacy of the INGA mechanical cervical ripening balloon catheter when used for induction of labor at term. The study is conducted as a medical device investigation in accordance with the Declaration of Helsinki, ICH-GCP principles, and applicable regulatory and ethical requirements. All participants provide written informed consent prior to participation. Mechanical cervical ripening is an established method for labor induction, particularly in women with an unfavorable cervix. Balloon catheters promote cervical ripening through direct mechanical dilation and stimulation of endogenous prostaglandin release, offering a non-pharmacological alternative to pharmacologic methods.
The INGA catheter is a single-use mechanical single-balloon device intended for placement between the fetal membranes and the internal cervical os during a vaginal examination. After insertion, the balloon is filled with sterile saline according to the device instructions for use and maintained under gentle traction. The device may remain in place for up to 24 hours or until spontaneous detachment. Cervical status is assessed prior to catheter insertion and following catheter detachment or removal, and further induction management, including amniotomy and/or oxytocin administration, is performed according to routine clinical practice. Outpatient cervical ripening may be permitted for selected participants based on predefined clinical criteria and local hospital practice.
The study enrolls approximately 30-50 pregnant women at ≥37 weeks of gestation with a singleton pregnancy in cephalic presentation and an unfavorable cervix (Bishop score ≤6) for whom induction of labor has been clinically indicated. Both nulliparous and multiparous women may participate. After providing written informed consent and confirmation of eligibility, participants undergo cervical ripening with the INGA catheter as part of standard induction care. The study does not include a comparison group.
The study collects clinical data during cervical ripening, labor, and delivery in order to characterize device performance in a real-world hospital setting. In addition to clinical outcomes, the investigation includes structured assessments of user experience. Participating women complete questionnaires regarding pain and overall experience related to catheter placement and retention. Healthcare professionals complete structured usability evaluations addressing ease of insertion, handling characteristics, and overall device performance.
Clinical data are collected during cervical ripening, labor, and delivery to characterize device performance in a real-world hospital setting. In addition to clinical outcomes, structured user-reported data are obtained. Participating women complete questionnaires addressing pain and overall experience during catheter placement and retention. Healthcare professionals complete structured evaluations of device usability, ease of insertion, handling characteristics, and overall performance.
Safety is assessed throughout cervical ripening and delivery by systematic monitoring and documentation of adverse events and device-related incidents in accordance with regulatory requirements. As an exploratory pilot investigation, the study is intended to generate preliminary clinical data to support further clinical development and future confirmatory studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A non-randomized, single-arm pilot study of a mechanical cervical ripening device that focuses on usability and performance outcomes and does not include a comparison group.
| Arm | Type | Receives |
|---|---|---|
| INGA catheter for cervical ripening | Experimental | Device: Cervical ripening, labor inductionParticipants 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. |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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:
- Gestational age at the time of the study ≥ 37 weeks (gestational age confirmed by ultrasound before the 21st week of pregnancy)
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Cervical ripening, labor inductionThis 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. | Device | INGA catheter for cervical ripening |
Primary outcome
Bishop score
Time frame: From catheter insertion to detachment
The change in Bishop score (on a scale from 0 to 10) during cervical ripening assessed prior to catheter insertion and after catheter detachment
6 secondary outcomes
Successful catheter placement (clinical assessment by investigator)
Time frame: Periprocedural (at the time of catheter insertion)
Retention time of the balloon catheter
Time frame: From balloon catheter placement to catheter detachment (up to 24 hours)
Induction to delivery interval
Time frame: From balloon catheter insertion to delivery of the neonate (assessed up to 48 hours after induction initiation)
Mode of delivery
Time frame: From enrolment to birth
Patient-reported pain assessment 30 minutes after catheter insertion
Time frame: Within 60 minutes after catheter insertion
Professionals' experience of insertion and catheter usability
Time frame: Periprocedural (after catheter insertion)
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: Yes. 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.
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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, Assoc.prof study chair
Aalto University, INGA Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical ripening, labor induction in people with Induction of Labor and Cervical Ripening, run by Aalto University at 3 sites in Finland.
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 15 inclusion and 17 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 3 sites in Finland. 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 (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.