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Not yet recruiting NCT07684521

Debriefing Consult for Psychiatric Symptoms After Severe Maternal Morbidity

No phase Interventional PTSD (Childbirth-Related) Severe Maternal Morbidity Depression - Major Depressive Disorder Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual maternal fetal medicine debriefing consult.
Who it may be relevant to
Registry conditions: PTSD (Childbirth-Related), Severe Maternal Morbidity, Depression - Major Depressive Disorder, Anxiety. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Virtual maternal fetal medicine debriefing consult
    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 outcome measures

  • Depression symptoms [Time frame: From 6 to 12 weeks postpartum]
  • PTSD symptoms [Time frame: From 6 to 12 weeks postpartum]
  • Anxiety symptoms [Time frame: From 6 to 12 weeks postpartum]

Eligibility criteria

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"

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Cedars Sinai Medical Center — Los Angeles

Identifiers

NCT: NCT07684521 · STUDY00004928

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗