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临床试验/NCT07537894
NCT07537894撤回2 期

Perioperative Dexmedetomidine to Reduce Post-procedure Grief Following Second-trimester Dilation and Evacuation

Stanford University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
入组人数
100
试验地点
1
主要终点
Reproductive Grief Screen

研究概览

简要总结

People seeking second-trimester dilation and evacuation (D&E) procedures are often facing profoundly challenging circumstances, including desired pregnancies complicated by fetal anomalies or demise, serious maternal health conditions, or changes in financial or relationship status. Although abortion regret is uncommon, the emotional burden surrounding these experiences is substantial: many patients experience significant grief and post-traumatic stress symptoms in the weeks to months following care. Perioperative interventions that decrease the body's stress response offer a promising opportunity to reduce downstream psychologic morbidity. Dexmedetomidine has been shown to reduce PTSD symptoms in other high-stress medical and surgical settings. The investigators are undertaking a randomized trial to evaluate whether perioperative administration of dexmedetomidine during second-trimester D&E can reduce the frequency and severity of post-procedural grief, directly addressing an unmet need in patient-centered, trauma-informed abortion care.

详细描述

The investigators will conduct a double-blinded, randomized, placebo-controlled, superiority trial of those undergoing D&E between 16 and 26-weeks gestation at Stanford Health Care to evaluate the following aims:

Aim 1: To assess the effect of perioperative dexmedetomidine on validated measures of grief in patients undergoing second-trimester D&E.

Aim 2: To evaluate the feasibility and implementation of perioperative dexmedetomidine within the routine workflow of outpatient OR-based D&E procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • English- or Spanish-fluency
  • 16-26 weeks gestation
  • D&E in the operating room

排除标准

  • Unscheduled or emergent procedure
  • Contraindication to dexmedetomidine per package insert
  • Judgement of clinical anesthesiologist providing care

研究组 & 干预措施

Dexmedetomidine

Experimental

Infused 0.5ug/kg over 10 minutes at anesthesia induction

干预措施: Dexmedetomidine (IV) 0.5 mcg/kg (Drug)

Placebo

Placebo Comparator

Saline at equal volume to intervention group

干预措施: Placebo (Drug)

结局指标

主要结局

Reproductive Grief Screen

时间窗: 2 weeks post-procedure

Validated 5-question survey to evaluate for pathologic grief

次要结局

  • Edinburgh Postnatal Depression Scale [EDPS](2 weeks post-procedure)
  • PTSD Checklist for DSM-5 (PCL-5)(2 weeks post-procedure)
  • Post-anesthesia care unit (PACU) length of stay(Immediately post-procedure (up to 6 hours))
  • Reproductive Grief Screen(4 weeks post-procedure)
  • Edinburgh Postnatal Depression Scale [EDPS](4 weeks post-procedure)
  • PTSD Checklist for DSM-5 (PCL-5)(4 weeks post-procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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