NCT03340701已完成1 期
Pharmacokinetics of Vaginal Progesterone in Pregnancy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Pharmacokinetic model
研究概览
简要总结
Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation
详细描述
Prospective study of 6 women with singleton pregnancies 18 0/7- 23 6/7 weeks' gestation with no prior preterm birth or short cervix who are administered a single dose of 200mg vaginal progesterone suppository. Serum progesterone levels will be drawn serially from pre-dose to 24 hours post-dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥18 years old pregnant with singleton gestation 16 0/7 - 23 6/7 weeks
- •pre-pregnancy BMI 20-40
- •no history of prior preterm birth
排除标准
- •history of an adverse reaction to progesterone
- •contraindication to progesterone treatment including prior or active thrombus, active hepatic disease, known adverse reaction to progesterone
- •medical comorbidity requiring medication including: hypertension, diabetes, substance abuse/methadone maintenance therapy, asthma, thyroid disease
- •major fetal anomaly diagnosed on ultrasound or known chromosomal disorder
- •multifetal gestation
- •vaginal bleeding, preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment or on Day 1 of study
- •any progesterone use of any form previously during the pregnancy
- •active vaginitis
- •Illicit substance use in pregnancy including cocaine, opiates, marijuana
- •abnormal pap smear/+HPV on most recent pap smear
- •known or suspected malignancy of the breast or genital organs
- •cervical length ≤25mm
研究组 & 干预措施
Vaginal Progesterone
Other
micronized progesterone vaginal suppository 200mg
干预措施: vaginal progesterone suppository (Drug)
结局指标
主要结局
Pharmacokinetic model
时间窗: 24 hours
Plasma concentration time profile of vaginal progesterone in pregnant women.
次要结局
未报告次要终点
研究者
研究点 (1)
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