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Not Yet RecruitingNCT07537894

Perioperative Dexmedetomidine to Reduce Post-procedure Grief Following Second-trimester Dilation and Evacuation

Status
Not Yet Recruiting
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Stanford University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDexmedetomidine (IV) 0.5 mcg/kgInfusion of dexmedetomidine 0.5ug/kg over 10 minutes at anesthesia induction
DRUGPlaceboSaline infusion at equal volume to intervention arm

Timeline

Start date
2026-07-01
Primary completion
2027-07-01
Completion
2028-07-01
First posted
2026-04-17
Last updated
2026-04-17

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07537894. Inclusion in this directory is not an endorsement.