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Предстои набиране Фаза 2/3 NCT07537894

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

Фаза 2/3 – комбинирано изпитване
Заболявания: Abortion Stillbirth PTSD (Childbirth-Related) Grief (Traumatic Grief and Existential Grief)

Спонсор: Stanford University

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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
Интервенции
Dexmedetomidine (IV) 0.5 mcg/kg
DRUG
Placebo
DRUG
Места на провеждане 1
САЩ (1)
Stanford Health Care
Palo Alto , California
Технически детайли
Статус
Предстои набиране
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Само жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.07.2026
Крайна дата
01.07.2028
Регистрационен номер
NCT07537894
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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