RCT for Women With a Persisting Pregnancy of Unknown Location
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 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.
Persistent Pregnancy of Unknown Location
Procedure: Uterine Evacuation
Other: Expectant Management
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Uterine evacuation followed by MTX for some
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.
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.Procedure: Uterine Evacuation
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.
Active Comparator: Empiric treatment with MTX for all
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.
Active Comparator: Expectant Management
Subjects will have their PPUL expectantly managed using serum hCG monitoring.
Other: Expectant Management
Pregnancy will be expectantly managed using serum hcg monitoring.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01800162
|Contact: Ashley Singer||Ashley.Singer@uphs.upenn.edu|
|United States, Florida|
|University of Miami||Not yet recruiting|
|Miami, Florida, United States, 33136|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Rhode Island|
|Brown University||Not yet recruiting|
|Providence, Rhode Island, United States, 02906|
|University of Amsterdam||Not yet recruiting|
|Principal Investigator:||Kurt T Barnhart, MD, MSCE||University of Pennsylvania|