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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abortion; Stillbirth; PTSD (Childbirth-Related); Grief (Traumatic Grief and Existential Grief)
• Intervention / Treatment: Drug: Dexmedetomidine (IV) 0.5 mcg/kg; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94062
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; Infused 0.5ug/kg over 10 minutes at anesthesia induction	Drug: Dexmedetomidine (IV) 0.5 mcg/kg; Infusion of dexmedetomidine 0.5ug/kg over 10 minutes at anesthesia induction
Placebo Comparator: Placebo; Saline at equal volume to intervention group	Drug: Placebo; Saline infusion at equal volume to intervention arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproductive Grief Screen	Validated 5-question survey to evaluate for pathologic grief	2 weeks post-procedure

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; dexmedetomidine; abortion; grief; stillbirth; fetal demise
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Urogenital Diseases; Mental Disorders; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Death; Stress Disorders, Traumatic; Pathological Conditions, Signs and Symptoms; Prolonged Grief Disorder; Stillbirth; Fetal Death; Stress Disorders, Post-Traumatic; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: 85799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No