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临床试验/NCT02620904
NCT02620904终止4 期

Mifepristone Induction for Fetal Demise, a Randomized Control Trial

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2016年7月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
9
试验地点
1
主要终点
Time to Delivery of Fetus

研究概览

简要总结

Methods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational age or greater.

Hypothesis: Mifepristone will expedite time to delivery of fetus among demise patients, when compared to placebo, and in conjunction with other pharmacologic methods for induction of labor.

Expected outcomes: The addition of a progesterone receptor modulator will expedite time to delivery of the fetus and ultimately improve the experience associated with induction of labor for fetal demise.

详细描述

The investigators propose a double blinded, randomized, placebo-controlled clinical trial at the time of initiation of induction of labor for fetal demise at 20 weeks gestational age or greater.

  1. Diagnose fetal demise: confirm absence of fetal heart motion by attending physician as per the institutional standards and protocols.
  2. Confirm gestational age at presentation to labor and delivery based on available medical records and/or ultrasonography as per standard practice and institutional protocols.
  3. Based on inclusion and exclusion criteria potential participants will be informed about the research, offered the opportunity to contribute, and trained research staff will complete the informed consent process. After documentation of consent and discussion of the research as indicated the participants will be randomized to the intervention or control arm. Both groups will receive emotional and physical support with induction of labor as per practice guidelines and standard of care by Montefiore physicians, faculty and staff irrespective of participation or assignment.
  4. Interventional Arm: Ingest 200mg tab of mifepristone orally. This will coincide with or be implemented prior to the initiation of the induction of labor plan as delineated by the attending physician. The timing will be sensitive to the needs of the participant and the labor and delivery room staff.
  5. Control Arm: Ingest a placebo tab orally with similar physical properties. This will coincide with or be implemented prior to the initiation of the induction of labor plan as delineated by the attending physician. The timing will be sensitive to the needs of the participant and the labor and delivery room staff.
  6. Montefiore protocol for induction of labor: will follow institutional standards.
  7. Data: Patient data will be collected by the Labor and Delivery staff via electronic medical record or paper record that will be scanned into the electronic medical record. The investigators will use data abstraction tools to collect information such as time of medication administration, medications administered, time of delivery of fetus, duration of admittance to labor and delivery, and postpartum course, or complications from the electronic medical record.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Intrauterine fetal death as confirmed by absence of cardiac motion on ultrasound by Attending physician at the time of admission to the hospital.
  • Estimated gestational age greater than 20 weeks
  • Hemodynamically stable and appropriate for induction of labor as per primary clinical health team in house
  • Women with one prior low transverse cesarean delivery

排除标准

  • History of 2 or more low transverse cesarean deliveries
  • Prior classical cesarean delivery
  • History of abdominal myomectomy
  • Known or suspected allergic reaction to mifepristone
  • Known or suspected adrenal gland disease
  • Known or suspected bleeding diatheses or coagulopathies
  • Known or suspected use of QTc-prolonging medication
  • Known maternal medical or physical conditions that prohibits vaginal delivery

研究组 & 干预措施

mifepristone

Active Comparator

following informed consent women will be randomized and the mifepristone group will take 200 mg by mouth immediately prior to induction of labor for fetal demise on labor and delivery

干预措施: Mifepristone (Drug)

placebo pill

Placebo Comparator

following informed consent women will be randomized and the placebo group will take a placebo pill by mouth (similar in properties to the mifepristone group, but it will lack any active drug) immediately prior to induction of labor for fetal demise on labor and delivery

干预措施: placebo (Drug)

结局指标

主要结局

Time to Delivery of Fetus

时间窗: From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours

From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Atrio

principal investigator

Montefiore Medical Center

研究点 (1)

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