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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English- or Spanish-fluency

16-26 weeks gestation

D&E in the operating room

Disqualifiers

Unscheduled or emergent procedure

Contraindication to dexmedetomidine per package insert

Judgement of clinical anesthesiologist providing care

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine (IV) 0.5 mcg/kg

    Drug

    Infusion of dexmedetomidine 0.5ug/kg over 10 minutes at anesthesia induction

  • Placebo

    Drug

    Saline infusion at equal volume to intervention arm

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: DexmedetomidineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reproductive Grief Screen

Validated 5-question survey to evaluate for pathologic grief

Time frame
2 weeks post-procedure

Secondary outcomes

1

Edinburgh Postnatal Depression Scale [EDPS]

Validated 10-question tool used to screen for perinatal and postpartum depression

Time frame
2 weeks post-procedure
2

PTSD Checklist for DSM-5 (PCL-5)

20-item tool measuring PTSD symptom severity

Time frame
2 weeks post-procedure
3

Post-anesthesia care unit (PACU) length of stay

Length of stay (in minutes) will be compared between groups.

Time frame
Immediately post-procedure (up to 6 hours)
4

Reproductive Grief Screen

Validated 5-question survey to evaluate for pathologic grief

Time frame
4 weeks post-procedure

Other outcomes

Sponsors and contacts

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