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

NCT07214948 | Not Yet Recruiting FDA Device

• 2 other identifiers: Pro00089090ARPA-H-ICHUB-24-101-1675/SWH-2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Induction of labor; Balloon Catheter; Cervical ripening

Outcome Measures

Primary Outcomes (1)

• Bishop Score Change

  Change in Bishop score (A scale from 1 to 10) during cervical ripening, with scores assessed before catheter insertion and after catheter detachment.

  From catheter insertion to detachment

Secondary Outcomes (6)

• Placement success

  At catheter insertion

• Retention time of balloon catheter

  From catheter placement to detachment, 0-24 hours

• Induction to delivery interval

  rom the start of balloon catheter insertion until the birth of the neonate, 0-48 hours

• Mode of delivery

  From enrolment to birth

• Pain experience during catheter insertion and in-place time

  Within 60 minutes from catheter insertion

Study Arms (2)

INGA Catheter

EXPERIMENTAL

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

Device: INGA Catheter

Currently used induction catheter

OTHER

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

Device: Currently used single balloon catheter

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

INGA Catheter

Currently used single balloon catheter DEVICE

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

Currently used induction catheter

Eligibility Criteria

• Age: 18 Years - 56 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged ≥18 and ≤56 years
• An unripe cervix, ≤6 points according to the Bishop score assessment (0-10-point scale)
• Planned induction of labor by balloon catheter method
• 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 informed consent

You may not qualify if:

• Preterm induction of labor (\<37 weeks of gestation)
• Clinically significant vaginal bleeding with a need of hospitalization in the third trimester
• Clinical active vaginal or uterine infection
• Maternal Human Immunodeficiency Virus (HIV), hepatitis C, or hepatitis B
• Uterine scar (including previous cesarean section)
• Condition requiring immediate delivery of the fetus or mother
• Presence of eclampsia
• Severe Preeclampsia \[Blood pressure (BP)≥ 160/110 and any of the following: thrombocytopenia with platelet count \<100 × 10e9/L, HELLP- syndrome ( Hemolysis, Elevated Liver enzymes and Low Platelets), progressive renal insufficiency, pulmonary edema \]
• Severe fetal growth restriction (Fetal Growth Restriction (FGR) fetal growth \<-2 SD/\<10th percentile)
• Estimated fetal weight ≥ 2 Standard Deviation /≥ 95th percentile
• Reduced amniotic fluid volume (deepest vertical pocket \<30 mill meter)
• Breech or transverse fetal position
• Multiple pregnancy
• Vasa previa or placenta previa
• Umbilical cord prolapses

Sponsors & Collaborators

• Aalto University: lead
• University of Mississippi Medical Center: collaborator
• University of Minnesota: collaborator

Study Officials

• Leena Rahkonen, MD,PhD, Associate Professor

  Aalto University

  STUDY CHAIR

Central Study Contacts

Kirsi Roivainen, Master of Health

CONTACT

+358505347653; kirsi.roivainen@mdsfinland.com

Heidi Kruit, MD, PhD, Associate Professor

CONTACT

+358504284685; heidi.kruit@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 9, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05