NCT01800162|TerminatedPhase 1/2ResultsDMCFDA Drug
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A new protocol was written to replace this protocol.
PPUL
Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location -- a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy
Sponsor study identifier
interventional
2
1 country
2
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
February 25, 2013
Actual (reported)February 27, 2013
Actual (reported)December 2013
Actual (reported)December 2013
Actual (reported)May 15, 2017
Actual (reported)Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.
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.
Outcome will be assessed within 6 weeks of randomization
Number of Ruptured Ectopic Pregnancies in Each Group
Outcome will be assess within 6 weeks of randomization
Quantification of Re-interventions Needed to Manage a Woman With a PPUL
6 weeks
Treatment Complications and Adverse Events
42 days after the last dose of study medication
Number of Procedures (Lab Tests, Ultrasounds)
6 weeks
Number of Visits
6 weeks
Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.
Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.
Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Greenville Hospital System University Medical Center
Greenville, South Carolina, 29605, United States
Kurt T Barnhart, MD, MSCE
University of Pennsylvania
2 participants (actual enrollment reported by the registry).
First Submitted
February 25, 2013
First Posted
February 27, 2013
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate
Subjects will have their PPUL expectantly managed using serum hCG monitoring.
Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation.
Pregnancy will be expectantly managed using serum hcg monitoring.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
December 29, 2017
Results First Posted
May 15, 2017
Record last verified: 2017-12
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Source: ClinicalTrials.gov.
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