Abortion, Complete, Fetal Death, Induction of Labor Affected Fetus / Newborn
Conditions
Keywords
induction termination, medication abortion
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.
Interventions
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.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cook Cervical Ripening Balloon
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience death | 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 | 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 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 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 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 diagnosed with a cervical laceration | During delivery hospitalization (within 72 hours after delivery) | — |
| 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 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 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported distress | Up to 6 weeks post-delivery | Impact of Event scale (0-88), with higher scores indicating higher levels of distress |
| 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 |
| 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 |
| 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 |
| Number of participants requiring dilation and curettage or manual extraction of the placenta | Within the first 12 hours after expulsion of the fetus | — |
| Patient-reported pain | Up to 6 weeks post-delivery | Use of visual analog scale (0-10), with higher scores indicating worse levels of pain |
Outcome results
None listed