NCT07537894

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
24mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

AbortionStillbirthPTSD (Childbirth-Related)Grief (Traumatic Grief and Existential Grief)

Keywords

abortiondexmedetomidinefetal demisestillbirthgriefPTSD

Outcome Measures

Primary Outcomes (1)

  • Reproductive Grief Screen

    Validated 5-question survey to evaluate for pathologic grief

    2 weeks post-procedure

Secondary Outcomes (6)

  • Edinburgh Postnatal Depression Scale [EDPS]

    2 weeks post-procedure

  • PTSD Checklist for DSM-5 (PCL-5)

    2 weeks post-procedure

  • Post-anesthesia care unit (PACU) length of stay

    Immediately post-procedure (up to 6 hours)

  • Reproductive Grief Screen

    4 weeks post-procedure

  • Edinburgh Postnatal Depression Scale [EDPS]

    4 weeks post-procedure

  • +1 more secondary outcomes

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Infused 0.5ug/kg over 10 minutes at anesthesia induction

Drug: Dexmedetomidine (IV) 0.5 mcg/kg

Placebo

PLACEBO COMPARATOR

Saline at equal volume to intervention group

Drug: Placebo

Interventions

Dexmedetomidine (IV) 0.5 mcg/kgDRUG

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

Dexmedetomidine
PlaceboDRUG

Saline infusion at equal volume to intervention arm

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English- or Spanish-fluency
  • weeks gestation
  • D\&E in the operating room

You may not qualify if:

  • Unscheduled or emergent procedure
  • Contraindication to dexmedetomidine per package insert
  • Judgement of clinical anesthesiologist providing care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Health Care

Palo Alto, California, 94062, United States

Location

Related Publications (1)

  • 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.

    PMID: 37326991BACKGROUND

MeSH Terms

Conditions

StillbirthStress Disorders, Post-TraumaticProlonged Grief DisorderFetal Death

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 17, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

US(1)