NCT02152696|CompletedPhase 3ResultsDMC
Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location
ACTorNOT
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Sponsor study identifier
Secondary identifiers
interventional
255
1 country
17
Study Start
July 25, 2014
Actual (reported)Primary Completion
August 2019
Actual (reported)Study Completion
August 19, 2019
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 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 19, 2019
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.
May 28, 2014
Actual (reported)June 2, 2014
Actual (reported)July 25, 2014
Actual (reported)August 2019
Actual (reported)August 19, 2019
Actual (reported)October 26, 2020
Actual (reported)Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy
The primary outcome measure in each of each 3 treatment arm is the uneventful clinical resolution of a PPUL without change in treatment from the initial management strategy.
6 weeks from randomization
Subjects will have their PPUL expectantly managed using serum hCG monitoring.
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.
University of California San Francisco
San Francisco, California, 94115, United States
Denver Health
Denver, Colorado, 80204, United States
Yale University
New Haven, Connecticut, 06520, United States
University of South Florida
Tampa, Florida, 33606, United States
Augusta University
Augusta, Georgia, 30912, United States
Northwestern University
Chicago, Illinois, 60611, United States
University Of Illinois at Chicago
Chicago, Illinois, 60612, United States
Barnhart KT, Hansen KR, Stephenson MD, Usadi R, Steiner AZ, Cedars MI, Jungheim ES, Hoeger KM, Krawetz SA, Mills B, Alston M, Coutifaris C, Senapati S, Sonalkar S, Diamond MP, Wild RA, Rosen M, Sammel MD, Santoro N, Eisenberg E, Huang H, Zhang H; Reproductive Medicine Network. Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location: The ACT or NOT Randomized Clinical Trial. JAMA. 2021 Aug 3;326(5):390-400. doi: 10.1001/jama.2021.10767.
Esther Eisenberg, MD MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD
University of Colorado, Denver
Kurt Barnhart, MD MSCE
University of Pennsylvania
Michael Diamond, MD
Augusta University
255 participants (actual enrollment reported by the registry).
First Submitted
May 28, 2014
First Posted
June 2, 2014
Study Start
July 25, 2014
Actual (reported)Primary Completion
Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
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.
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.
Wayne State University
Southfield, Michigan, 48034, United States
Washington University
St Louis, Missouri, 63108, United States
University of Rochester
Rochester, New York, 14642, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center - Women's Institute
Charlotte, North Carolina, 28204, United States
Duke University
Durham, North Carolina, 27708, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Greenville Health System
Greenville, South Carolina, 29605, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Richard Legro, MD
Penn State University
Marcelle Cedars, MD
University of California, San Francisco
Anne Steiner, MD MPH
University of North Carolina
Karl Hansen, MD PhD
University of Oklahoma
Christos Coutifaris, MD PhD
University of Pennsylvania
Heping Zhang, PhD
Yale University
August 2019
Actual (reported)Study Completion
August 19, 2019
Actual (reported)Last Updated
December 8, 2020
Results First Posted
October 26, 2020
Record last verified: 2020-11
IPD will be shared with other researchers through the NICHD DASH system. It will be available 6 months after publication of the primary results.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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