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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Induction of Labor; Cervical Ripening; Cervical Ripening and Induction of Labor
• Intervention / Treatment: Device: Cervical ripening, 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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirsi Roivainen, Master of Health; Phone Number: +358 (0)50 534 7653; Email: kirsi.roivainen@mdsfinland.com
• Study Contact Backup: Name: Heidi Kruit, MD, PhD, Assoc.prof; Phone Number: +358 (0)50 428 4685; Email: heidi.kruit@hus.fi

Study Locations

• Finland
  • Jyväskylä, Finland, 40620
    • Hospital Nova
    • Contact: Kirsi Väyrynen, MD, PhD; Phone Number: +35814 269 1811; Email: kirsi.vayrynen@hyvaks.fi
  • Tampere, Finland, 33101
    • Tampere University Hospital
    • Contact: Kati Tihtonen, MD, PhD, Associate professor; Phone Number: +358207 907 330; Email: kati.tihtonen@pirha.fi
  • HUS
    • Helsinki, HUS, Finland, 00029
      • Helsinki University Hospital
      • Contact: Heidi Kruit, MD, PhD, Associate Professor; Phone Number: +358504284685; Email: heidi.kruit@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: INGA catheter for cervical ripening; 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.

Device: Cervical ripening, labor induction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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)	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)	Periprocedural (after catheter insertion)

Collaborators and Investigators

• Sponsor: Aalto University
• Collaborators: Helsinki University Central Hospital; Tampere University Hospital; Jyväskylä Central Hospital
• Investigators: Study Chair: Leena Rahkonen, MD, PhD, Assoc.prof, Aalto University, INGA Health

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Induction of labor; Cervical ripening; Balloon catheter
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Delivery, Obstetric; Obstetric Surgical Procedures; Labor, Induced
• Other Study ID Numbers: HUS/451/2025; ARPA-H-ICHUB-24-101-1675/SWH-2 (Other Grant/Funding Number: ARPA-H)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes