IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion

Induction of Labor Affected Fetus / Newborn Clinical Trial

— CERBI  

Official title:

IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion (CERBI): a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456164
• Other study ID #: IRB24-0835
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: University of Chicago
• Contact: Ashish Premkumar, MD, PhD
• Phone: 773-702-3239
• Email: premkumara[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Complete
• Fetal Death
• Induction of Labor Affected Fetus / Newborn

Intervention

Device:
• Cook Cervical Ripening Balloon
The Cook Cervical Ripening Balloon is a double-balloon catheter designed to mechanically ripen the cervix prior to labor induction when the cervix is unfavorable for induction.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants diagnosed with sepsis	Sepsis in Obstetrics Score > 6. Score calculated from maximum maternal temperature, blood pressure, heart rate, respiratory rate, O2 saturation, white blood cell count, and serum lactic acid	Up to 6 weeks post-delivery
Primary	Number of participants diagnosed with septic shock	Hypotension requiring vasopressors to maintain MAP =65 mm Hg and serum lactate level >2 mmol/L (18mg/dL) despite adequate volume resuscitation	Up to 6 weeks post-delivery
Primary	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
Primary	Number of participants requiring blood transfusion after expulsion of the fetus and placenta		Up to 6 weeks post-delivery
Primary	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
Primary	Number of participants diagnosed with a cervical laceration		During delivery hospitalization (within 72 hours after delivery)
Primary	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
Primary	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)
Primary	Number of participants diagnosed with a uterine rupture		Within the first 12 hours after expulsion of the fetus
Primary	Number of participants requiring intensive care unit admission		Up to 6 weeks post-delivery
Primary	Number of participants requiring readmission to the hospital within 6 weeks of delivery		Up to 6 weeks post-delivery
Primary	Number of participants who experience death		Up to 6 weeks post-delivery
Secondary	Patient-reported pain	Use of visual analog scale (0-10), with higher scores indicating worse levels of pain	Up to 6 weeks post-delivery
Secondary	Patient-reported distress	Impact of Event scale (0-88), with higher scores indicating higher levels of distress	Up to 6 weeks post-delivery
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Number of participants requiring dilation and curettage or manual extraction of the placenta		Within the first 12 hours after expulsion of the fetus