StudyFinder
An open, parallel-group, randomized, early feasibility trial to evaluate the initial safety and performance of the INGA catheter in labor induction
Status: Recruiting
The purpose of this study is to evaluate the safety and effectiveness of a new device used during labor induction. We will enroll pregnant adults who are at least 37 weeks pregnant and are scheduled to have labor induced using a balloon catheter. The study will evaluate whether the device can improve monitoring of the pregnant person and baby during labor.
Sex: Female
Age Group: 18 years and over
Inclusion Criteria:
• pregnant adults ages 18–56
• at least 37 weeks pregnant
• pregnant with one baby
• planning to have labor induced using a balloon catheter
Exclusion Criteria:
• pregnant with more than one baby (twins, triplets, etc.)
• baby is not in a head-down position
• previous cesarean section or other surgery that left a scar on the uterus
• you or your baby need immediate delivery for medical reasons
Conditions:
Women's Health
Keywords:
catheter, Labor, pregnant
Study Contact: Mubina Fareed - faree008@umn.edu
Principal Investigator: Shruthi Chandra
IRB Number: STUDY00028791