Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

Completed · Phase 3

Conditions studied: Persistent Pregnancy of Unknown Location, Ectopic Pregnancy

In brief

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.

Key facts

Study ID

NCT02152696

Run by

Yale University

People needed

255

Starts

2014-07-25

Expected to finish

2019-08-19

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Denver Health — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• University of South Florida — Tampa, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University Of Illinois at Chicago — Chicago, Illinois, United States
• Wayne State University — Southfield, Michigan, United States
• Washington University — St Louis, Missouri, United States
• University of Rochester — Rochester, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Carolinas Medical Center - Women's Institute — Charlotte, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Greenville Health System — Greenville, South Carolina, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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