Abortion, Grief (Traumatic Grief and Existential Grief), PTSD (Childbirth-Related), Stillbirth
Conditions
Keywords
abortion, dexmedetomidine, fetal demise, stillbirth, grief, PTSD
Brief 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. 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.
Interventions
Infusion of dexmedetomidine 0.5ug/kg over 10 minutes at anesthesia induction
DRUGPlacebo
Saline infusion at equal volume to intervention arm
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English- or Spanish-fluency * 16-26 weeks gestation * D\&E in the operating room
Exclusion criteria
* Unscheduled or emergent procedure * Contraindication to dexmedetomidine per package insert * Judgement of clinical anesthesiologist providing care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reproductive Grief Screen | 2 weeks post-procedure | Validated 5-question survey to evaluate for pathologic grief |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Postnatal Depression Scale [EDPS] | 2 weeks post-procedure | Validated 10-question tool used to screen for perinatal and postpartum depression |
| PTSD Checklist for DSM-5 (PCL-5) | 2 weeks post-procedure | 20-item tool measuring PTSD symptom severity |
| Post-anesthesia care unit (PACU) length of stay | Immediately post-procedure (up to 6 hours) | Length of stay (in minutes) will be compared between groups. |
| Reproductive Grief Screen | 4 weeks post-procedure | Validated 5-question survey to evaluate for pathologic grief |
Countries
United States
Outcome results
None listed