跳至主要内容
临床试验/NCT07684521
NCT07684521尚未招募不适用

Does a Debriefing Intervention After a Delivery Complicated by Severe Maternal Morbidity Reduce Post-traumatic, Depression, or Anxiety Symptoms? A Randomized Controlled Trial

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
试验地点
1
主要终点
Depression symptoms

研究概览

简要总结

The primary objective of this study is to determine if a maternal fetal medicine (MFM) debriefing consult six to eight weeks postpartum reduces self-reported post-traumatic stress, depression, and anxiety symptoms following a delivery complicated by severe maternal morbidity (SMM). Individuals with a delivery complicated an intensive care unit (ICU) admission and/or blood product transfusion >4 units will be included in this study. Participants will be randomized to an intervention or control group; all participants will complete patient questionnaires that screen for post-traumatic stress disorder, depression, and anxiety. Those in the control group will receive a virtual MFM debriefing consult at six weeks postpartum and those in the intervention group will have the option for a consult at twelve weeks postpartum, after the completion of the questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • - Individuals with a delivery complicated by severe maternal morbidity, defined as intensive care unit (ICU) admission and/or blood product transfusion >4 units

排除标准

  • Age <18 years
  • Non-English speakers
  • Any records flagged "break the glass" or "research opt out"

结局指标

主要结局

Depression symptoms

时间窗: From 6 to 12 weeks postpartum

Edinburgh Postnatal Depression Scale (EPDS) score

PTSD symptoms

时间窗: From 6 to 12 weeks postpartum

Impact of Event Scale - Revised (IES-R) score

Anxiety symptoms

时间窗: From 6 to 12 weeks postpartum

Generalized Anxiety Disorder 7-item (GAD-7) score

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

Sarah Kilpatrick

Chair, Department of Obstetrics and Gynecology

Cedars-Sinai Medical Center

研究点 (1)

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