Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location -- a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.
研究概览
简要总结
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
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Methotrexate (Drug)
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.
干预措施: Uterine Evacuation (Procedure)
Empiric treatment with MTX for all
Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.
干预措施: Methotrexate (Drug)
Expectant Management
Subjects will have their PPUL expectantly managed using serum hCG monitoring.
干预措施: Expectant Management (Other)
结局指标
主要结局
Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.
时间窗: Outcome will be assessed within 6 weeks of randomization
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.
次要结局
- Time to Resolution(6 weeks)
- Patients' Preferences(6 weeks)
- Treatment Complications and Adverse Events(42 days after the last dose of study medication)
- Number of Procedures (Lab Tests, Ultrasounds)(6 weeks)
- Number of Visits(6 weeks)
- Acceptability(6 weeks)
- Number of Ruptured Ectopic Pregnancies in Each Group(Outcome will be assess within 6 weeks of randomization)
- Quantification of Re-interventions Needed to Manage a Woman With a PPUL(6 weeks)
- Future Fertility(6 weeks)