Debriefing Consult for Psychiatric Symptoms After Severe Maternal Morbidity

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT07684521
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Depression - Major Depressive Disorder
  • PTSD (Childbirth-Related)
  • Severe Maternal Morbidity

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Virtual maternal fetal medicine debriefing consult — BEHAVIORAL
    The intervention is virtual debriefing consult with a maternal fetal medicine subspecialist. This intervention involves review of the patient's hospital course and delivery experience, and recommendations for future pregnancies if desired.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2030

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention group
    At six weeks postpartum, subjects will receive a questionnaire on mental health symptoms. Subjects in the intervention group will then be scheduled for a virtual maternal fetal medicine debriefing consult between six and eight weeks postpartum. At twelve weeks postpartum, subjects will repeat the mental health symptom questionnaire.
  • No Intervention: Control group
    At six weeks postpartum, subjects will receive a questionnaire on mental health symptoms. At twelve weeks postpartum, subjects will repeat the mental health symptom questionnaire. Following completion of both questionnaires, subjects in the control group will have the option to complete a virtual maternal fetal medicine debriefing consult.

Primary Outcome Measure

Depression symptoms [ Time Frame: From 6 to 12 weeks postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Sarena Hayer, MD, MA, MSc
[email protected]
323-866-8107

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By research site
Cedars Sinai Medical Center· Los Angeles, CA

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