PTSD (Childbirth-Related)NCT07684521
Debriefing Consult for Psychiatric Symptoms After Severe Maternal Morbidity
A study testing Virtual maternal fetal medicine debriefing consult in people with PTSD (Childbirth-Related) and Severe Maternal Morbidity, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PTSD (Childbirth-Related), Severe Maternal Morbidity, Depression - Major Depressive Disorder
- What is being tested?
- Virtual maternal fetal medicine debriefing consult
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a delivery complicated by severe maternal morbidity, defined as intensive care unit (ICU) admission and/or blood product transfusion >4 units
Who cannot join
- Age <18 years
- Non-English speakers
- Any records flagged "break the glass" or "research opt out"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
Sarena Hayer, MD, MA, MSc, 323-866-8107, sarena.hayer@cshs.org
About this study
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
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.
- Conditions
- PTSD (Childbirth-Related), Severe Maternal Morbidity, Depression - Major Depressive Disorder, Anxiety
- Being tested
- Virtual maternal fetal medicine debriefing consult
- Keywords
- severe materal morbidity, PTSD, anxiety, depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual maternal fetal medicine debriefing consultBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual maternal fetal medicine debriefing consult |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
Edinburgh Postnatal Depression Scale (EPDS) score
Measured: From 6 to 12 weeks postpartum
PTSD symptoms
Impact of Event Scale - Revised (IES-R) score
Measured: From 6 to 12 weeks postpartum
Anxiety symptoms
Generalized Anxiety Disorder 7-item (GAD-7) score
Measured: From 6 to 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD (Childbirth-Related)Studies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Kilpatrick, Cedars-Sinai Medical Center
- Investigators
- Sarah Kilpatrick, MD, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684521
- Sponsor's protocol ID
- STUDY00004928
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07684521
- Acronym / sponsor ID
- STUDY00004928
- Conditions
- PTSD (Childbirth-Related), Severe Maternal Morbidity, Depression - Major Depressive Disorder, Anxiety
- Keywords
- severe materal morbidity, PTSD, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Virtual maternal fetal medicine debriefing consultAt 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with a delivery complicated by severe maternal morbidity, defined as intensive care unit (ICU) admission and/or blood product transfusion >4 units
Key exclusion criteria (3 listed)
- Age <18 years
- Non-English speakers
- Any records flagged "break the glass" or "research opt out"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual maternal fetal medicine debriefing consultThe 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. | Behavioural | Intervention group |
Primary outcome
Depression symptoms
Time frame: From 6 to 12 weeks postpartum
Edinburgh Postnatal Depression Scale (EPDS) score
PTSD symptoms
Time frame: From 6 to 12 weeks postpartum
Impact of Event Scale - Revised (IES-R) score
Anxiety symptoms
Time frame: From 6 to 12 weeks postpartum
Generalized Anxiety Disorder 7-item (GAD-7) score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Kilpatrick, MD, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual maternal fetal medicine debriefing consult in people with PTSD (Childbirth-Related) and Severe Maternal Morbidity, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarena Hayer, MD, MA, MSc (323-866-8107, sarena.hayer@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms (time frame: From 6 to 12 weeks postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.