Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Marcelle Cedars

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 Cardiac Complexes, Premature Pregnancy, Ectopic Methotrexate Uterine Evacuation Expectant Management

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 California San Francisco accepting new patients
    San Francisco California 94115 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84132 United States
  • Denver Health not yet accepting patients
    Denver Colorado 80204 United States
  • University of Oklahoma accepting new patients
    Oklahoma City Oklahoma 73104 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Yale University
ID
NCT02152696
Phase
Phase 3
Lead Scientist
Marcelle Cedars
Study Type
Interventional
Last Updated
June 21, 2018