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Eligibility
for females ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Persistent Pregnancy of Unknown Location Ectopic Pregnancy Methotrexate

Eligibility

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

Locations

  • 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Yale University
ID
NCT02152696
Phase
Phase 3
Study Type
Interventional
Last Updated
May 1, 2017
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