Stopped: Study has not received IRB approval.
The goal of this research is to understand whether it is practical and safe to use an intracervical balloon catheter in addition to standard of care medications at the time of an induction of labor for an abortion or fetal death. The medical device used in this study is cleared by the Food and Drug Administration (FDA) and is used for induction of labor at term gestational ages (at or above 37 weeks of gestation). The study team will also collect data about patient-level experiences with the procedure, time in labor, and labor-related complications, such as higher-than-expected blood loss or infection.
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of participants diagnosed with clinical chorioamnionitis or postpartum endometritis
Timeframe: Up to 6 weeks post-delivery
Number of participants diagnosed with sepsis
Timeframe: Up to 6 weeks post-delivery
Number of participants diagnosed with septic shock
Timeframe: Up to 6 weeks post-delivery
Number of participants diagnosed with postpartum hemorrhage
Timeframe: Up to 6 weeks post-delivery
Number of participants requiring blood transfusion after expulsion of the fetus and placenta
Timeframe: Up to 6 weeks post-delivery
Number of participants requiring uterotonics
Timeframe: Up to 6 weeks post-delivery
Number of participants diagnosed with a cervical laceration
Timeframe: During delivery hospitalization (within 72 hours after delivery)
Number of participants requiring adjunctive procedures in the setting of postpartum hemorrhage
Timeframe: Up to 6 weeks post-delivery
Number of participants requiring hysterotomy or dilation and evacuation
Timeframe: During delivery hospitalization (within the first 72 hours after admission)
Number of participants diagnosed with a uterine rupture
Timeframe: Within the first 12 hours after expulsion of the fetus
Number of participants requiring intensive care unit admission
Timeframe: Up to 6 weeks post-delivery
Number of participants requiring readmission to the hospital within 6 weeks of delivery
Timeframe: Up to 6 weeks post-delivery
Number of participants who experience death
Timeframe: Up to 6 weeks post-delivery