Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Treatment Efficacy
研究概览
简要总结
A pilot cohort study to preliminarily investigate the efficacy of pretreatment with letrozole 10 mg daily for three consecutive days followed by treatment with misoprostol 800 mcg vaginally for medical management of early pregnancy loss in a US population. Patients will be followed to assess efficacy of this treatment regimen, as well as additional interventions needed, side effects, adverse events, and patient acceptability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to participate in the informed consent process and provide a signed and dated consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Access to working mobile phone
- •English-speaking
- •Age 18 years or older
- •Confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)
排除标准
- •Incomplete or inevitable abortion
- •Contraindication of allergy to letrozole or misoprostol
- •Unable to return for clinic-based follow-up
- •Twin or multiple pregnancy
研究组 & 干预措施
Letrozole & Misprostol
Letrozole 10 mg orally daily for three consecutive days followed by misoprostol 800 mcg vaginally within 24 hours of final letrozole dose
干预措施: Letrozole (Drug)
Letrozole & Misprostol
Letrozole 10 mg orally daily for three consecutive days followed by misoprostol 800 mcg vaginally within 24 hours of final letrozole dose
干预措施: Misoprostol (Drug)
结局指标
主要结局
Treatment Efficacy
时间窗: Visit 2 (Days 10-11)
Absence of gestational sac on transvaginal ultraound
次要结局
- Acceptability(30 days)