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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | Infused 0.5ug/kg over 10 minutes at anesthesia induction |
|
| Placebo | Placebo Comparator | Saline at equal volume to intervention group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine (IV) 0.5 mcg/kg | Drug | Infusion of dexmedetomidine 0.5ug/kg over 10 minutes at anesthesia induction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reproductive Grief Screen | Validated 5-question survey to evaluate for pathologic grief | 2 weeks post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Edinburgh Postnatal Depression Scale [EDPS] | Validated 10-question tool used to screen for perinatal and postpartum depression | 2 weeks post-procedure |
| PTSD Checklist for DSM-5 (PCL-5) | 20-item tool measuring PTSD symptom severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Palo Alto | California | 94062 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37326991 | Background | 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. |
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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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| Placebo | Drug | Saline infusion at equal volume to intervention arm |
|
| 2 weeks post-procedure |
| Post-anesthesia care unit (PACU) length of stay | Length of stay (in minutes) will be compared between groups. | Immediately post-procedure (up to 6 hours) |
| Reproductive Grief Screen | Validated 5-question survey to evaluate for pathologic grief | 4 weeks post-procedure |
| Edinburgh Postnatal Depression Scale [EDPS] | Validated 10-question tool used to screen for perinatal and postpartum depression | 4 weeks post-procedure |
| PTSD Checklist for DSM-5 (PCL-5) | 20-item tool measuring PTSD symptom severity | 4 weeks post-procedure |
| ID | Term |
|---|---|
| D050497 | Stillbirth |
| D013313 | Stress Disorders, Post-Traumatic |
| D000090382 | Prolonged Grief Disorder |
| D005313 | Fetal Death |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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