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 ]
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