Debriefing Consult for Psychiatric Symptoms After Severe Maternal Morbidity

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07684521

Enrollment

Registered

2026-07-06

Start date

2026-07-01

Completion date

2030-07-01

Last updated

2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

severe materal morbidity, PTSD, anxiety, depression

Brief summary

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

BEHAVIORALVirtual 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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"

Design outcomes

Primary

Measure	Time frame	Description
Depression symptoms	From 6 to 12 weeks postpartum	Edinburgh Postnatal Depression Scale (EPDS) score
PTSD symptoms	From 6 to 12 weeks postpartum	Impact of Event Scale - Revised (IES-R) score
Anxiety symptoms	From 6 to 12 weeks postpartum	Generalized Anxiety Disorder 7-item (GAD-7) score

Countries

United States

Contacts

CONTACTSarena Hayer, MD, MA, MSc

sarena.hayer@cshs.org323-866-8107

PRINCIPAL_INVESTIGATORSarah Kilpatrick, MD, PhD

Cedars-Sinai Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026