Clinical trial NCT06456164: IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion
Official title: IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion (CERBI): a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Abortion, Complete
Fetal Death
Induction of Labor Affected Fetus / Newborn
Keywords: induction termination
medication abortion
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cook Cervical Ripening Balloon
Primary purpose: TREATMENT

Brief 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.

Detailed description: Commonly, induction of labor in the second trimester is accomplished with the use of oral anti-progestin medications (i.e., mifepristone) at least 24 hours prior to administration of sublingual, buccal, or vaginal prostaglandins (e.g., misoprostol). Innovation over the past decade has largely been focused on the concomitant use of mechanical dilation for induction of labor in order to reduce the time from initiation of labor to delivery. However, limited data exist to demonstrate the efficacy of an intracervical balloon catheter during second-trimester induction of labor. Therefore, the principal investigator seeks to conduct a feasibility randomized controlled trial to evaluate whether an intracervical balloon catheter - commonly used for inductions of labor at later gestational ages - can be used during second-trimester inductions of labor.

Eligibility criteria: Inclusion Criteria:

* Maternal age ≥ 18
* English or Spanish-speaking
* Cervical dilation \< 3 centimeters
* Gestational age between 22w0d and 27w6d

Exclusion Criteria:

* Maternal age \< 18
* Non-English- or Spanish-speaking
* Cervical dilation ≥ 3 centimeters
* Gestational age below 22w0d or above 27w6d
* Allergy to mifepristone or misoprostol
* Hemolysis, Elevated Liver Enzymes, and Low Platelets (HELLP) syndrome
* Disseminated intravascular coagulopathy
* Placenta previa or suspected placenta accreta spectrum disorder
* Placental abruption
* Suspected intraamniotic infection
* Rupture of membranes
* Untreated genitourinary tract infection
* 3 or more cesarean deliveries, classical cesarean delivery, or endometrial cavity-entering myomectomy

Primary outcomes:
measure: Number of participants diagnosed with clinical chorioamnionitis or postpartum endometritis
timeFrame: Up to 6 weeks post-delivery
measure: Number of participants diagnosed with sepsis
timeFrame: Up to 6 weeks post-delivery
measure: Number of participants diagnosed with septic shock
timeFrame: Up to 6 weeks post-delivery
measure: Number of participants diagnosed with postpartum hemorrhage
timeFrame: Up to 6 weeks post-delivery
measure: Number of participants requiring blood transfusion after expulsion of the fetus and placenta
timeFrame: Up to 6 weeks post-delivery
measure: Number of participants requiring uterotonics
timeFrame: Up to 6 weeks post-delivery
measure: Number of participants diagnosed with a cervical laceration
timeFrame: During delivery hospitalization (within 72 hours after delivery)
measure: Number of participants requiring adjunctive procedures in the setting of postpartum hemorrhage
timeFrame: Up to 6 weeks post-delivery
measure: Number of participants requiring hysterotomy or dilation and evacuation
timeFrame: During delivery hospitalization (within the first 72 hours after admission)
measure: Number of participants diagnosed with a uterine rupture
timeFrame: Within the first 12 hours after expulsion of the fetus
measure: Number of participants requiring intensive care unit admission
timeFrame: Up to 6 weeks post-delivery
measure: Number of participants requiring readmission to the hospital within 6 weeks of delivery
timeFrame: Up to 6 weeks post-delivery
measure: Number of participants who experience death
timeFrame: Up to 6 weeks post-delivery
Secondary outcomes:
measure: Patient-reported pain
timeFrame: Up to 6 weeks post-delivery
measure: Patient-reported distress
timeFrame: Up to 6 weeks post-delivery
measure: Patient-reported acceptability of intervention
timeFrame: Up to 6 weeks post-delivery
measure: Patient-reported satisfaction
timeFrame: During intrapartum period (up to 72 hours after delivery)
measure: Total duration of labor, in hours
timeFrame: During intrapartum period (up to 72 hours after delivery)
measure: Total blood loss, in milliliters
timeFrame: Within the first 24 hours after expulsion of the fetus and placenta
measure: Number of participants requiring dilation and curettage or manual extraction of the placenta
timeFrame: Within the first 12 hours after expulsion of the fetus
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: Ashish Premkumar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: