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NCT Number: NCT07684521

Debriefing Consult for Psychiatric Symptoms After Severe Maternal Morbidity

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.

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Key information

Conditions

PTSD (Childbirth-Related) Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depression - Major Depressive Disorder Mental Disorders Severe Maternal Morbidity Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location contact

Sarena Hayer, MD, MA, MSc

CONTACT

[email protected]

323-866-8107

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Depression symptoms

    Time frame: From 6 to 12 weeks postpartum

    Edinburgh Postnatal Depression Scale (EPDS) score

  2. PTSD symptoms

    Time frame: From 6 to 12 weeks postpartum

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

  3. Anxiety symptoms

    Time frame: From 6 to 12 weeks postpartum

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sarena Hayer, MD, MA, MSc

CONTACT

[email protected]

323-866-8107

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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