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Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location (ACTorNOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152696
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : April 15, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Augusta University
Penn State University
University of California, San Francisco
University of North Carolina
University of Oklahoma
University of Pennsylvania
Information provided by (Responsible Party):
Yale University

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 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.

Condition or disease Intervention/treatment Phase
Persistent Pregnancy of Unknown Location Ectopic Pregnancy Drug: Methotrexate Procedure: Uterine Evacuation Other: Expectant Management Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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: Active Treatment Versus No Treatment
Actual Study Start Date : May 2014
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Active Comparator: Uterine evacuation with 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.
Drug: Methotrexate
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.
Drug: Methotrexate
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.




Primary Outcome Measures :
  1. Uneventful clinical resolution of a Pregnancy of Unknown Location without change from the initial management strategy [ Time Frame: 6 weeks from randomization ]
    The primary outcome measure in each of each 3 treatment arm is the uneventful clinical resolution of a PPUL without change from the initial management strategy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female with a persisting pregnancy of unknown location:
  • A pregnancy of unknown location is defined as a pregnancy in a woman with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging. A definitive sign of gestation includes ultrasound visualization of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in the adnexa. Ultrasound must be performed within 7 days prior to randomization.
  • Persistence of hCG is defined as at least 2 serial hCG values (over 2-14 days), showing < 15% rise per day, or < 50% fall between the first and last value.
  • Patient is hemodynamically stable, hemoglobin >10 mg/dL
  • Greater than or 18 years of age

Exclusion Criteria:

  • Hemodynamically unstable in need of acute treatment
  • Most recent hCG > 5000 mIU/mL
  • Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion)
  • Diagnosis of gestational trophoblastic disease
  • Subject unwilling or unable to comply with study procedures
  • Known hypersensitivity to MTX
  • Presence of clinical contraindications for treatment with MTX
  • Prior medical or surgical management of this gestation
  • Subject unwilling to accept a blood transfusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152696


Locations
Show Show 17 study locations
Sponsors and Collaborators
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Augusta University
Penn State University
University of California, San Francisco
University of North Carolina
University of Oklahoma
University of Pennsylvania
Investigators
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Study Director: Esther Eisenberg, MD MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Nanette Santoro, MD University of Colorado, Denver
Principal Investigator: Kurt Barnhart, MD MSCE University of Pennsylvania
Study Director: Michael Diamond, MD Augusta University
Study Director: Richard Legro, MD Penn State University
Study Director: Marcelle Cedars, MD University of California, San Francisco
Study Director: Anne Steiner, MD MPH University of North Carolina
Study Director: Karl Hansen, MD PhD University of Oklahoma
Study Director: Christos Coutifaris, MD PhD University of Pennsylvania
Study Director: Heping Zhang, PhD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02152696    
Other Study ID Numbers: 2000023590
2U10HD055925-06 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared with other researchers through the NICHD DASH system. It will be available 6 months after publication of the primary results.
Additional relevant MeSH terms:
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Pregnancy, Ectopic
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Pregnancy Complications
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors