IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion
NCT Number: NCT06456164
Acronym: CERBI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Abortion, Complete|Fetal Death|Induction of Labor Affected Fetus / Newborn
Interventions: DEVICE: Cook Cervical Ripening Balloon
Sponsor: University of Chicago
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12

Summary:
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.

Primary Outcome Measures: Number of participants diagnosed with clinical chorioamnionitis or postpartum endometritis, Maternal temperature greater than 39°C or 38-38.9°C with evidence of leukocytosis or purulent cervical drainage, Up to 6 weeks post-delivery|Number of participants diagnosed with sepsis, Sepsis in Obstetrics Score \> 6. Score calculated from maximum maternal temperature, blood pressure, heart rate, respiratory rate, oxygen saturation, white blood cell count, and serum lactic acid, Up to 6 weeks post-delivery|Number of participants diagnosed with septic shock, Hypotension requiring vasopressors to maintain mean arterial pressure ≥65 mm Hg and serum lactate level \>2 mmol/L (18mg/dL) despite adequate volume resuscitation, Up to 6 weeks post-delivery|Number of participants diagnosed with postpartum hemorrhage, Estimated or quantitative blood loss greater than 1000 mL at the conclusion of expulsion of the fetus and placenta, Up to 6 weeks post-delivery|Number of participants requiring blood transfusion after expulsion of the fetus and placenta, Up to 6 weeks post-delivery|Number of participants requiring uterotonics, Need for misoprostol, carboprost, and/or methergine after expulsion of the fetus and/or placenta, Up to 6 weeks post-delivery|Number of participants diagnosed with a cervical laceration, During delivery hospitalization (within 72 hours after delivery)|Number of participants requiring adjunctive procedures in the setting of postpartum hemorrhage, Dilation and curettage, insertion of intrauterine tamponade device (i.e., Bakri or Jada devices), uterine artery embolization, exploratory laparotomy, O'Leary and/or B-Lynch sutures, and/or other uterine-conserving surgical measures to control hemorrhage, Up to 6 weeks post-delivery|Number of participants requiring hysterotomy or dilation and evacuation, Need for hysterotomy or dilation and evacuation in setting of failed induction of labor, During delivery hospitalization (within the first 72 hours after admission)|Number of participants diagnosed with a uterine rupture, Within the first 12 hours after expulsion of the fetus|Number of participants requiring intensive care unit admission, Up to 6 weeks post-delivery|Number of participants requiring readmission to the hospital within 6 weeks of delivery, Up to 6 weeks post-delivery|Number of participants who experience death, Up to 6 weeks post-delivery
Secondary Outcome Measures: Patient-reported pain, Use of visual analog scale (0-10), with higher scores indicating worse levels of pain, Up to 6 weeks post-delivery|Patient-reported distress, Impact of Event scale (0-88), with higher scores indicating higher levels of distress, Up to 6 weeks post-delivery|Patient-reported acceptability of intervention, assessed via the question "Would you have the same procedure again if you had to have another second-trimester induction of labor?" and "Did you think the second-trimester induction of labor was better or worse than expected?", Up to 6 weeks post-delivery|Patient-reported satisfaction, Client Satisfaction Questionnaire-8 (8-22), with higher scores indicating higher levels of satisfaction, During intrapartum period (up to 72 hours after delivery)|Total duration of labor, in hours, Total duration from initiation of misoprostol to expulsion of the fetus, in hours, During intrapartum period (up to 72 hours after delivery)|Total blood loss, in milliliters, Total blood loss after expulsion of the fetus and placenta, Within the first 24 hours after expulsion of the fetus and placenta|Number of participants requiring dilation and curettage or manual extraction of the placenta, Within the first 12 hours after expulsion of the fetus