Does a Debriefing Intervention After a Delivery Complicated by Severe Maternal Morbidity Reduce Post-traumatic, Depression, or Anxiety Symptoms? A Randomized Controlled Trial
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
- 否
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
Sarah Kilpatrick
Chair, Department of Obstetrics and Gynecology
Cedars-Sinai Medical Center
