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

Study Status: Terminated
Recruit Status: Terminated
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

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, and 3) Expectant management. Randomization will be 2:2:1 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. Secondary outcome measures: re-interventions, treatment complications, health-related quality of life, financial costs, future fertility, and patient's preferences.

Detailed Summary:
Sponsor: University of Pennsylvania

Current Primary Outcome: Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL. [ Time Frame: Outcome will be assessed within 6 weeks of randomization ]

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.


Original Primary Outcome: frequency of clinical resolution for the 3 difference management arms for a persisting PUL. [ Time Frame: Outcome will be assessed within 6 weeks of randomization ]

Current Secondary Outcome:

  • Number of Ruptured Ectopic Pregnancies in Each Group [ Time Frame: 6 weeks ]
    Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
  • Quantification of Re-interventions Needed to Manage a Woman With a PPUL [ Time Frame: 6 weeks ]

    Outcomes include:

    • number of interventions beyond that of intended initial strategy in each group

      • additional number of MTX injections
      • additional surgical procedures
    • uterine evacuation (or dilation and curettage)
    • laparoscopy
    • laparotomy
  • Treatment Complications and Adverse Events [ Time Frame: 42 days after the last dose of study medication ]
    Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
  • Number of Procedures (Lab Tests, Ultrasounds) [ Time Frame: 6 weeks ]
    Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
  • Number of Visits [ Time Frame: 6 weeks ]
    Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
  • Time to Resolution [ Time Frame: 6 weeks ]
    Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
  • Patients' Preferences [ Time Frame: 6 weeks ]
    Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
  • Acceptability [ Time Frame: 6 weeks ]
    Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
  • Future Fertility [ Time Frame: 6 weeks ]
    Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.


Original Secondary Outcome:

Information By: University of Pennsylvania

Dates:
Date Received: February 25, 2013
Date Started: February 2013
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017