Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location - a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy: Active Treatment Versus No Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 17
- 主要终点
- Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy
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 3) Expectant management. Randomization will be 1:1:1 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.
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 pregnancy in a woman with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging. A definitive sign of gestation includes ultrasound visualization of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in the adnexa. Ultrasound must be performed within 7 days prior to randomization.
- •Persistence of hCG is defined as at least 2 serial hCG values (over 2-14 days), showing < 15% rise per day, or < 50% fall between the first and last value.
- •Patient is hemodynamically stable, hemoglobin >10 mg/dL
- •Greater than or 18 years of age
排除标准
- •Hemodynamically unstable in need of acute treatment
- •Most recent hCG > 5000 mIU/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
- •Known hypersensitivity to MTX
- •Presence of clinical contraindications for treatment with MTX
- •Prior medical or surgical management of this gestation
- •Subject unwilling to accept a blood transfusion
研究组 & 干预措施
Expectant Management
Subjects will have their PPUL expectantly managed using serum hCG monitoring.
干预措施: Expectant Management (Other)
Uterine evacuation with 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 with 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)
结局指标
主要结局
Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy
时间窗: 6 weeks from randomization
The primary outcome measure in each of each 3 treatment arm is the uneventful clinical resolution of a PPUL without change in treatment from the initial management strategy.
次要结局
未报告次要终点