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Study has not received IRB approval.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Participants will receive mifepristone 200 mg by mouth 24 hours prior to induction of labor. Labor will be induced with use of vaginal misoprostol according to regimens endorsed by the American College of Obstetricians and Gynecologists and the Society of Family Planning. | |
| Usual care with mechanical dilation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook Cervical Ripening Balloon | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashish Premkumar, MD PhD | University of Chicago | Principal Investigator |
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Once data are peer-reviewed and published, the investigators will plan to share individual participant data with other researchers.
Within 1 year after completion of data analysis,
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| ID | Term |
|---|---|
| D005313 | Fetal Death |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
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Cook Cervical Ripening Balloon
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| 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 |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |