Vaginal Administration of Alpha Lipoic Acid vs Progesterone for the Subchorionic Hematoma Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination
研究概览
简要总结
The aim of this study was to compare the therapeutic efficacy of lipoic acid versus progesterone by vaginal administration on subchorionic hematoma resorption in women at the first trimester of pregnancy with threatened miscarriage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 24-37
- •Gestational week: 7- 12
- •Evidence of threatened miscarriage (pelvic pain with or without vaginal bleeding)
- •Ultrasound evidence of subchorionic hematoma
排除标准
- •Lack of fetus
- •Absence of fetal heart tone
- •Uterine anomaly or fetal anomaly
- •Presence of multiple pregnancy
- •Gestation pathology
- •Therapies with anti-coagulants or anti-hypertensive drugs
研究组 & 干预措施
Lipoic acid
vaginal capsules of lipoic acid (10 mg, one capsule per day)
干预措施: Lipoic acid (Device)
Progesterone
Vaginal soft gel of progesterone (200 mg, two capsules per day)
干预措施: Progesterone (Drug)
结局指标
主要结局
Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination
时间窗: T1 (20 days); T2 (40 days)
The evaluation of the hematoma significance is done comparing its size with that one of the gestational sac during the ultrasound examination. Changes in hematoma resorption (% improvement/ worsening) during the treatment were obtained for each patient by calculating the Δ percentage between two subsequent time points.
次要结局
- Number of participants with abdominal pain as assessed by questionnaire(T2 (40 days))
- Number of participants with vaginal bleeding as assessed by questionnaire(T2 (40 days))
- Number of participants who miscarried as assessed by ultrosound examination(20 weeks of gestation)
研究者
Demetrio Costantino
Medical Doctor
Azienda USL Ferrara