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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 56 Years

Healthy Volunteers

Not accepted

Interventions

• INGA Catheter — DEVICE
  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 catheter — DEVICE
  Insertion of a balloon catheter through the cervical canal into the uterus for induction of labor.

Study Details

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.

Key Dates

First listed

Oct 9, 2025

Start date

Jul 3, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2026

Completion

Oct 30, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: INGA Catheter
  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
• Other: Currently used induction catheter
  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

Primary Outcome Measure

Bishop Score Change [ Time Frame: From catheter insertion to detachment ]

Central Contacts

• Kirsi Roivainen, Master of Health
  +358505347653
  [email protected]
• Heidi Kruit, MD, PhD, Associate Professor
  +358504284685
  [email protected]

Locations (2)

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