Debriefing Consult for Psychiatric Symptoms After Severe Maternal Morbidity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCedars-Sinai Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Age <18 years

Non-English speakers

Any records flagged "break the glass" or "research opt out"

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Depression symptoms

Edinburgh Postnatal Depression Scale (EPDS) score

Time frame
From 6 to 12 weeks postpartum
2

PTSD symptoms

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

Time frame
From 6 to 12 weeks postpartum
3

Anxiety symptoms

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

Time frame
From 6 to 12 weeks postpartum

Secondary outcomes

Other outcomes

Sponsors and contacts

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Cedars-Sinai Medical Center

Lead sponsor

Cedars Sinai Medical Center, Los Angeles, USA

Collaborator

This trial is not recruiting at the moment. You can still explore other options: