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| Name | Class |
|---|---|
| Cedars Sinai Medical Center, Los Angeles, USA | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
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| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression symptoms | Edinburgh Postnatal Depression Scale (EPDS) score | From 6 to 12 weeks postpartum |
| PTSD symptoms | Impact of Event Scale - Revised (IES-R) score | From 6 to 12 weeks postpartum |
| Anxiety symptoms | Generalized Anxiety Disorder 7-item (GAD-7) score | From 6 to 12 weeks postpartum |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarena Hayer, MD, MA, MSc | Contact | 323-866-8107 | sarena.hayer@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Kilpatrick, MD, PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| D001519 | Behavior |