IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion
- Conditions
- Fetal DeathInduction of Labor Affected Fetus / NewbornAbortion, Complete
- Interventions
- Device: Cook Cervical Ripening Balloon
- Registration Number
- NCT06456164
- Lead Sponsor
- University of Chicago
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- Maternal age ≥ 18
- English or Spanish-speaking
- Cervical dilation < 3 centimeters
- Gestational age between 22w0d and 27w6d
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care with mechanical dilation Cook Cervical Ripening Balloon Participants will receive mifepristone 200 mg by mouth 24 hours prior to induction of labor. Participants will have their labor induced concomitantly with misoprostol (according to the regimen described in the "Usual Care" arm) and placement of the Cook Cervical Ripening Balloon.
- Primary Outcome Measures
Name Time Method Number of participants diagnosed with septic shock Up to 6 weeks post-delivery Hypotension requiring vasopressors to maintain mean arterial pressure ≥65 mm Hg and serum lactate level \>2 mmol/L (18mg/dL) despite adequate volume resuscitation
Number of participants requiring hysterotomy or dilation and evacuation During delivery hospitalization (within the first 72 hours after admission) Need for hysterotomy or dilation and evacuation in setting of failed induction of labor
Number of participants who experience death Up to 6 weeks post-delivery Number of participants diagnosed with a uterine rupture Within the first 12 hours after expulsion of the fetus Number of participants diagnosed with sepsis Up to 6 weeks post-delivery 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
Number of participants requiring intensive care unit admission Up to 6 weeks post-delivery Number of participants diagnosed with postpartum hemorrhage Up to 6 weeks post-delivery Estimated or quantitative blood loss greater than 1000 mL at the conclusion of expulsion of the fetus and placenta
Number of participants requiring blood transfusion after expulsion of the fetus and 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 Up to 6 weeks post-delivery 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
Number of participants diagnosed with clinical chorioamnionitis or postpartum endometritis Up to 6 weeks post-delivery Maternal temperature greater than 39°C or 38-38.9°C with evidence of leukocytosis or purulent cervical drainage
Number of participants requiring uterotonics Up to 6 weeks post-delivery Need for misoprostol, carboprost, and/or methergine after expulsion of the fetus and/or placenta
Number of participants requiring readmission to the hospital within 6 weeks of delivery Up to 6 weeks post-delivery
- Secondary Outcome Measures
Name Time Method Patient-reported distress Up to 6 weeks post-delivery Impact of Event scale (0-88), with higher scores indicating higher levels of distress
Number of participants requiring dilation and curettage or manual extraction of the placenta Within the first 12 hours after expulsion of the fetus Total duration of labor, in hours During intrapartum period (up to 72 hours after delivery) Total duration from initiation of misoprostol to expulsion of the fetus, in hours
Patient-reported pain Up to 6 weeks post-delivery Use of visual analog scale (0-10), with higher scores indicating worse levels of pain
Total blood loss, in milliliters Within the first 24 hours after expulsion of the fetus and placenta Total blood loss after expulsion of the fetus and placenta
Patient-reported acceptability of intervention Up to 6 weeks post-delivery 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?"
Patient-reported satisfaction During intrapartum period (up to 72 hours after delivery) Client Satisfaction Questionnaire-8 (8-22), with higher scores indicating higher levels of satisfaction