Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location
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.
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
Persistent Pregnancy of Unknown Location Ectopic Pregnancy Methotrexate
You can join if…
Open to females ages 18 years and up
- 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
You CAN'T join if...
- 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
- University of California San Francisco accepting new patients
San Francisco, California, 94115, United States
- University of Utah not yet accepting patients
Salt Lake City, Utah, 84132, United States
- University of Oklahoma accepting new patients
Oklahoma City, Oklahoma, 73104, United States
- Washington University accepting new patients
Saint Louis, Missouri, 63108, United States
- University Of Illinois at Chicago accepting new patients
Chicago, Illinois, 60612, United States
- Northwestern University accepting new patients
Chicago, Illinois, 60611, United States
- Wayne State University accepting new patients
Southfield, Michigan, 48034, United States
- Greenville Health System accepting new patients
Greenville, South Carolina, 29605, United States
- Augusta University accepting new patients
Augusta, Georgia, 30912, United States
- Carolinas Medical Center - Women's Institute accepting new patients
Charlotte, North Carolina, 28204, United States
- University of North Carolina accepting new patients
Chapel Hill, North Carolina, 27599, United States
- University of South Florida accepting new patients
Tampa, Florida, 33606, United States
- University of Rochester accepting new patients
Rochester, New York, 14642, United States
- Pennsylvania State University accepting new patients
Hershey, Pennsylvania, 17033, United States
- University of Pennsylvania accepting new patients
Philadelphia, Pennsylvania, 19104, United States
- accepting new patients
- Start Date
- Completion Date
- Yale University
- Phase 3
- Study Type
- Last Updated
- May 1, 2017
Please contact me about this study
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02152696.