MedTrace Logo

Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction

NCT07214948 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-02-12

No results posted yet for this study

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. 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.

Conditions

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

Interventions

DEVICE

INGA Catheter

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

DEVICE

Currently used single balloon catheter

Insertion of a balloon catheter through the cervical canal into the uterus for induction of labor.

Sponsors & Collaborators

  • University of Mississippi Medical Center

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Aalto University

    lead OTHER

Principal Investigators

  • Leena Rahkonen, MD,PhD, Associate Professor · Aalto University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2026-07-31
Completion
2026-10-30
FDA Device
Yes

More Related Trials

Entities

Companies

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 NCT07214948 on ClinicalTrials.gov