NCT04026789Unknown不适用
Medication Abortion for Pregnancy of Unknown Location
Planned Parenthood League of Massachusetts2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2019年7月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Time to completed abortion
研究概览
简要总结
The purpose of this study is to compare time to completed abortion between two protocols for patients seeking medication abortion - same-day start versus delay-for-diagnosis - in the setting of asymptomatic, low-risk, pregnancy of unknown location.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with an undesired pregnancy of less than or equal to 42 days gestation based on last menstrual period (LMP) who present to Planned Parenthood League of Massachusetts (PPLM)'s Greater Boston Health Center seeking medication abortion will be considered for study participation.
- •Inclusion criteria:
- •Positive urine or serum hCG test
- •No evidence of gestational sac on transvaginal ultrasound
- •Desire for medication abortion as method of pregnancy termination
排除标准
- •Ineligible for medication abortion at PPLM based on current PPLM clinical guidelines
- •Reasonable clinical suspicion for ectopic or molar pregnancy, such as abnormal or concerning ultrasound findings
- •High risk for ectopic pregnancy, such as prior ectopic pregnancy, history of tubal surgery, concurrent intrauterine device in place during this pregnancy
- •Exhibiting symptoms of possible ectopic, such as vaginal bleeding or abdominal pain
- •LMP > 42 days or unknown LMP
- •Age less than 18 years
- •Prior participation in this study
- •Anticipated inability to present for scheduled follow-up visits
结局指标
主要结局
Time to completed abortion
时间窗: through study completion, an average of two weeks
Time to completed abortion as defined by the number of days between initial ultrasound diagnosis of PUL to the diagnostic test that confirms complete abortion
次要结局
- Rate of ectopic pregnancy(Within 2 weeks of identification of pregnancy of unknown location on ultrasound)
- Number of participants with complete expulsion of pregnancy without surgical intervention(14 days after initiation of medical abortion)
- Time to diagnosis of pregnancy outcome(Within 2 weeks of identification of pregnancy of unknown location on ultrasound)
- Percent of participants who complete follow-up and confirm complete abortion(Within 1 month of identification of pregnancy of unknown location on ultrasound)
研究者
研究点 (2)
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