RCT for Women With a Persisting Pregnancy of Unknown Location (PPUL)
2017年12月5日 更新者:University of Pennsylvania
Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location -- a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy
This is a randomized controlled trial to compare three currently available management strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them at-risk for ectopic pregnancy.
We will recruit hemodynamically stable women with a confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy) 2) Empiric treatment with MTX for all, and 3) Expectant management.
Randomization will be 2:2:1 into these three arms.
After randomization, they will be followed and treated clinically as is indicated by the progression of their condition.
Primary outcome measures: uneventful decline of hCG to 5 IU/mL.
Secondary outcome measures: re-interventions, treatment complications, health-related quality of life, financial costs, future fertility, and patient's preferences.
研究概览
研究类型
介入性
注册 (实际的)
2
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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South Carolina
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Greenville、South Carolina、美国、29605
- Greenville Hospital System University Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
Female with a persisting pregnancy of unknown location:
- A pregnancy of unknown location is defined as a women with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging (Ultrasound must be performed within 7 days prior to randomization)
- Persistence of hCG is defined as 3 serial hCG values over 4-14 days or 2 serial hCG values over 7-14 days, showing less than 30% rise, or less than 30% fall between the first and last value. (This abnormal pattern of serial hCG confirms that the gestation is nonviable.)
- Patient is hemodynamically stable, hemoglobin greater than 10 mg/dL,
- Greater than or 18 years of age
Exclusion Criteria:
- Hemodynamically unstable in need of acute treatment
- Most recent hCG greater than 5000 IU/mL
- Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion),
- Diagnosis of gestational trophoblastic disease,
- Subject unwilling or unable to comply with study procedures,
- Presence of clinical contraindications for treatment with methotrexate (ACOG guidelines, Appendix B),
- Prior medical or surgical management of this gestation.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:期待管理
受试者将使用血清 hCG 监测对其 PPUL 进行预期管理。
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Pregnancy will be expectantly managed using serum hcg monitoring.
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有源比较器:对所有人进行 MTX 经验性治疗
受试者将接受甲氨蝶呤治疗,在第 0 天接受一剂,随后在第 4 天接受一剂。根据 hCG 水平,将根据需要给予额外剂量。
|
两剂方案:患者将在治疗第 0 天接受第一剂 MTX 50mg/m2。
她将在治疗第 4 天接受第二剂 MTX 50mg/m2,并将绘制血清 hCG 水平。
随后的 MTX 剂量将根据 hCG 水平进行给药。
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有源比较器:Uterine evacuation, then MTX for some
Subjects will undergo a uterine evacuation.
If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate.
If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.
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两剂方案:患者将在治疗第 0 天接受第一剂 MTX 50mg/m2。
她将在治疗第 4 天接受第二剂 MTX 50mg/m2,并将绘制血清 hCG 水平。
随后的 MTX 剂量将根据 hCG 水平进行给药。
清宫术或扩宫刮宫术。
根据临床医生的判断,这可以使用局部麻醉、镇静或全身麻醉进行,并且可以使用手动或电动疏散。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.
大体时间:Outcome will be assessed within 6 weeks of randomization
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Data was not analyzed as the study was closed early.
Data is not anticipated to be analyzed for this study.
Patients were not followed for outcome.
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Outcome will be assessed within 6 weeks of randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Ruptured Ectopic Pregnancies in Each Group
大体时间:Outcome will be assess within 6 weeks of randomization
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Data was not analyzed as the study was closed early.
Data is not anticipated to be analyzed for this study.
Patients were not followed for outcome.
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Outcome will be assess within 6 weeks of randomization
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Quantification of Re-interventions Needed to Manage a Woman With a PPUL
大体时间:6 weeks
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Outcomes include:
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6 weeks
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Treatment Complications and Adverse Events
大体时间:42 days after the last dose of study medication
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Data was not analyzed as the study was closed early.
Data is not anticipated to be analyzed for this study.
Patients were not followed for outcome.
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42 days after the last dose of study medication
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Number of Procedures (Lab Tests, Ultrasounds)
大体时间:6 weeks
|
Data was not analyzed as the study was closed early.
Data is not anticipated to be analyzed for this study.
Patients were not followed for outcome.
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6 weeks
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Number of Visits
大体时间:6 weeks
|
Data was not analyzed as the study was closed early.
Data is not anticipated to be analyzed for this study.
Patients were not followed for outcome.
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6 weeks
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Time to Resolution
大体时间:6 weeks
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Data was not analyzed as the study was closed early.
Data is not anticipated to be analyzed for this study.
Patients were not followed for outcome.
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6 weeks
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Patients' Preferences
大体时间:6 weeks
|
Data was not analyzed as the study was closed early.
Data is not anticipated to be analyzed for this study.
Patients were not followed for outcome.
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6 weeks
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Acceptability
大体时间:6 weeks
|
Data was not analyzed as the study was closed early.
Data is not anticipated to be analyzed for this study.
Patients were not followed for outcome.
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6 weeks
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Future Fertility
大体时间:6 weeks
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Data was not analyzed as the study was closed early.
Data is not anticipated to be analyzed for this study.
Patients were not followed for outcome.
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6 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年2月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2013年2月25日
首先提交符合 QC 标准的
2013年2月25日
首次发布 (估计)
2013年2月27日
研究记录更新
最后更新发布 (实际的)
2017年12月29日
上次提交的符合 QC 标准的更新
2017年12月5日
最后验证
2017年12月1日
更多信息
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