IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion (CERBI): a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 主要终点
- Number of participants diagnosed with clinical chorioamnionitis or postpartum endometritis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age ≥ 18
- •English or Spanish-speaking
- •Cervical dilation < 3 centimeters
- •Gestational age between 22w0d and 27w6d
排除标准
- •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
研究组 & 干预措施
Usual Care
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
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.
干预措施: Cook Cervical Ripening Balloon (Device)
结局指标
主要结局
Number of participants diagnosed with clinical chorioamnionitis or postpartum endometritis
时间窗: 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 who experience death
时间窗: Up to 6 weeks post-delivery
Number of participants diagnosed with septic shock
时间窗: 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 a uterine rupture
时间窗: Within the first 12 hours after expulsion of the fetus
Number of participants requiring uterotonics
时间窗: 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 hysterotomy or dilation and evacuation
时间窗: 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 sepsis
时间窗: 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
时间窗: Up to 6 weeks post-delivery
Number of participants diagnosed with postpartum hemorrhage
时间窗: 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
时间窗: Up to 6 weeks post-delivery
Number of participants diagnosed with a cervical laceration
时间窗: During delivery hospitalization (within 72 hours after delivery)
Number of participants requiring adjunctive procedures in the setting of postpartum hemorrhage
时间窗: 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 readmission to the hospital within 6 weeks of delivery
时间窗: Up to 6 weeks post-delivery
次要结局
- Patient-reported distress(Up to 6 weeks post-delivery)
- Patient-reported pain(Up to 6 weeks post-delivery)
- 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 blood loss, in milliliters(Within the first 24 hours after expulsion of the fetus and placenta)
- Patient-reported acceptability of intervention(Up to 6 weeks post-delivery)
- Patient-reported satisfaction(During intrapartum period (up to 72 hours after delivery))