Clinical Trial: Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Versu

Brief 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.

Detailed Summary:
Sponsor: Yale University

Current Primary Outcome: Uneventful clinical resolution of a Pregnancy of Unknown Location without change from the initial management strategy [ Time Frame: 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 from the initial management strategy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Yale University

Dates:
Date Received: May 28, 2014
Date Started: May 2014
Date Completion: May 2021
Last Updated: May 5, 2017
Last Verified: May 2017