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Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)

NCT07414771 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Induction of Labor
  • Cervical Ripening
  • Cervical Ripening and Induction of Labor

Interventions

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.

Sponsors & Collaborators

  • Tampere University Hospital

    collaborator OTHER

  • Jyväskylä Central Hospital, Jyväskylä

    collaborator UNKNOWN

  • Helsinki University Central Hospital

    collaborator OTHER

  • Aalto University

    lead OTHER

Principal Investigators

  • Leena Rahkonen, MD, PhD, Assoc.prof · Aalto University, INGA Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
56 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-09-30
Completion
2027-03-31
FDA Device
Yes

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07414771 on ClinicalTrials.gov