AbortionPhase 2/3NCT07537894
Perioperative Dexmedetomidine to Reduce Post-procedure Grief Following Second-trimester Dilation and Evacuation
A Phase 2/3 study testing Dexmedetomidine (IV) 0.5 mcg/kg in people with Abortion and Stillbirth, run by Stanford University at 1 site in United States.
Trial summary
People seeking second-trimester dilation and evacuation (D\&E) procedures are often facing profoundly challenging circumstances, including desired pregnancies complicated by fetal anomalies or demise, serious maternal health conditions, or changes in financial or relationship status. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion, Stillbirth, PTSD (Childbirth-Related)
- What is being tested?
- Dexmedetomidine (IV) 0.5 mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Jul 2028
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- English- or Spanish-fluency
- 16-26 weeks gestation
- D\&E in the operating room
Who cannot join
- Unscheduled or emergent procedure
- Contraindication to dexmedetomidine per package insert
- Judgement of clinical anesthesiologist providing care
Trial locations and contacts
1 site in 1 country.
About this study
People seeking second-trimester dilation and evacuation (D\&E) procedures are often facing profoundly challenging circumstances, including desired pregnancies complicated by fetal anomalies or demise, serious maternal health conditions, or changes in financial or relationship status. Although abortion regret is uncommon, the emotional burden surrounding these experiences is substantial: many patients experience significant grief and post-traumatic stress symptoms in the weeks to months following care. Perioperative interventions that decrease the body's stress response offer a promising opportunity to reduce downstream psychologic morbidity. Dexmedetomidine has been shown to reduce PTSD symptoms in other high-stress medical and surgical settings. The investigators are undertaking a randomized trial to evaluate whether perioperative administration of dexmedetomidine during second-trimester D\&E can reduce the frequency and severity of post-procedural grief, directly addressing an unmet need in patient-centered, trauma-informed abortion care.
Read the detailed description
The investigators will conduct a double-blinded, randomized, placebo-controlled, superiority trial of those undergoing D\&E between 16 and 26-weeks gestation at Stanford Health Care to evaluate the following aims:
Aim 1: To assess the effect of perioperative dexmedetomidine on validated measures of grief in patients undergoing second-trimester D\&E.
Aim 2: To evaluate the feasibility and implementation of perioperative dexmedetomidine within the routine workflow of outpatient OR-based D\&E procedures.
- Conditions
- Abortion, Stillbirth, PTSD (Childbirth-Related), Grief (Traumatic Grief and Existential Grief)
- Being tested
- Dexmedetomidine (IV) 0.5 mcg/kg, Placebo
- Keywords
- abortion, dexmedetomidine, fetal demise, stillbirth, grief, PTSD
- Medical subject headings
- Stillbirth, Stress Disorders, Post-Traumatic, Prolonged Grief Disorder, Fetal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine (IV) 0.5 mcg/kgDrug
Infusion of dexmedetomidine 0.5ug/kg over 10 minutes at anesthesia induction
PlaceboDrug
Saline infusion at equal volume to intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Infused 0.5ug/kg over 10 minutes at anesthesia induction Receives: Drug: Dexmedetomidine (IV) 0.5 mcg/kg |
| Placebo | Placebo comparator | Saline at equal volume to intervention group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproductive Grief Screen
Validated 5-question survey to evaluate for pathologic grief
Measured: 2 weeks post-procedure
Secondary outcomes (6)
Edinburgh Postnatal Depression Scale [EDPS]
Validated 10-question tool used to screen for perinatal and postpartum depression
Measured: 2 weeks post-procedure
PTSD Checklist for DSM-5 (PCL-5)
20-item tool measuring PTSD symptom severity
Measured: 2 weeks post-procedure
Post-anesthesia care unit (PACU) length of stay
Length of stay (in minutes) will be compared between groups.
Measured: Immediately post-procedure (up to 6 hours)
Reproductive Grief Screen
Validated 5-question survey to evaluate for pathologic grief
Measured: 4 weeks post-procedure
Edinburgh Postnatal Depression Scale [EDPS]
Validated 10-question tool used to screen for perinatal and postpartum depression
Measured: 4 weeks post-procedure
PTSD Checklist for DSM-5 (PCL-5)
20-item tool measuring PTSD symptom severity
Measured: 4 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AbortionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537894
- Sponsor's protocol ID
- 85799
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary study results and will include the study protocol, data dictionary, and analytic code where applicable. Requests will be reviewed by the study investigators to ensure that proposed analyses are scientifically valid and that participant confidentiality is protected. Data will be shared through a secure data transfer mechanism following execution of a data use agreement.
Publications
Yu Y, Li Y, Han D, Gong C, Wang L, Li B, Yao R, Zhu Y. Effect of Dexmedetomidine on Posttraumatic Stress Disorder in Patients Undergoing Emergency Trauma Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2318611. doi: 10.1001/jamanetworkopen.2023.18611.
PubMed 37326991
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Dexmedetomidine to Reduce Post-procedure Grief Following Second-trimester Dilation and Evacuation
- ClinicalTrials.gov ID
- NCT07537894
- Acronym / sponsor ID
- 85799
- Conditions
- Abortion, Stillbirth, PTSD (Childbirth-Related), Grief (Traumatic Grief and Existential Grief)
- Keywords
- abortion, dexmedetomidine, fetal demise, stillbirth, grief, PTSD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 17 Apr 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.
People seeking second-trimester dilation and evacuation (D\&E) procedures are often facing profoundly challenging circumstances, including desired pregnancies complicated by fetal anomalies or demise, serious maternal health conditions, or changes in financial or relationship status. Although abortion regret is uncommon, the emotional burden surrounding these experiences is substantial: many patients experience significant grief and post-traumatic stress symptoms in the weeks to months following care. Perioperative interventions that decrease the body's stress response offer a promising opportunity to reduce downstream psychologic morbidity. Dexmedetomidine has been shown to reduce PTSD symptoms in other high-stress medical and surgical settings. The investigators are undertaking a randomized trial to evaluate whether perioperative administration of dexmedetomidine during second-trimester D\&E can reduce the frequency and severity of post-procedural grief, directly addressing an unmet need in patient-centered, trauma-informed abortion care.
Detailed description
The investigators will conduct a double-blinded, randomized, placebo-controlled, superiority trial of those undergoing D\&E between 16 and 26-weeks gestation at Stanford Health Care to evaluate the following aims:
Aim 1: To assess the effect of perioperative dexmedetomidine on validated measures of grief in patients undergoing second-trimester D\&E.
Aim 2: To evaluate the feasibility and implementation of perioperative dexmedetomidine within the routine workflow of outpatient OR-based D\&E procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine (IV) 0.5 mcg/kgInfused 0.5ug/kg over 10 minutes at anesthesia induction |
| Placebo | Placebo comparator | Drug: PlaceboSaline at equal volume to intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English- or Spanish-fluency
- 16-26 weeks gestation
- D\&E in the operating room
Key exclusion criteria (3 listed)
- Unscheduled or emergent procedure
- Contraindication to dexmedetomidine per package insert
- Judgement of clinical anesthesiologist providing care
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 |
|---|---|---|
| Dexmedetomidine (IV) 0.5 mcg/kgInfusion of dexmedetomidine 0.5ug/kg over 10 minutes at anesthesia induction | Drug | Dexmedetomidine |
| PlaceboSaline infusion at equal volume to intervention arm | Drug | Placebo |
Primary outcome
Reproductive Grief Screen
Time frame: 2 weeks post-procedure
Validated 5-question survey to evaluate for pathologic grief
6 secondary outcomes
Edinburgh Postnatal Depression Scale [EDPS]
Time frame: 2 weeks post-procedure
PTSD Checklist for DSM-5 (PCL-5)
Time frame: 2 weeks post-procedure
Post-anesthesia care unit (PACU) length of stay
Time frame: Immediately post-procedure (up to 6 hours)
Reproductive Grief Screen
Time frame: 4 weeks post-procedure
Edinburgh Postnatal Depression Scale [EDPS]
Time frame: 4 weeks post-procedure
PTSD Checklist for DSM-5 (PCL-5)
Time frame: 4 weeks post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 37326991Yu Y, Li Y, Han D, Gong C, Wang L, Li B, Yao R, Zhu Y. Effect of Dexmedetomidine on Posttraumatic Stress Disorder in Patients Undergoing Emergency Trauma Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2318611. doi: 10.1001/jamanetworkopen.2023.18611.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary study results and will include the study protocol, data dictionary, and analytic code where applicable. Requests will be reviewed by the study investigators to ensure that proposed analyses are scientifically valid and that participant confidentiality is protected. Data will be shared through a secure data transfer mechanism following execution of a data use agreement.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine (IV) 0.5 mcg/kg in people with Abortion and Stillbirth, run by Stanford University 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 3 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: withdrawn, as of the sponsor's last update on 17 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproductive Grief Screen (time frame: 2 weeks post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07537894, which also lists 1 linked publication.
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 17 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.