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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 : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : February 6, 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

Tracking Information
First Submitted Date  ICMJE May 28, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02152696 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Persistent Pregnancy of Unknown Location
  • Ectopic Pregnancy
Intervention  ICMJE
  • 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.
  • Other: Expectant Management
    Pregnancy will be expectantly managed using serum hcg monitoring
Study Arms  ICMJE
  • Active Comparator: Expectant Management
    Subjects will have their PPUL expectantly managed using serum hCG monitoring.
    Intervention: Other: Expectant Management
  • 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.
    Interventions:
    • Drug: Methotrexate
    • Procedure: Uterine 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.
    Intervention: Drug: Methotrexate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 17, 2019)
255
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2014)
276
Estimated Study Completion Date  ICMJE March 2020
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152696
Other Study ID Numbers  ICMJE ACTorNOT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account Yale University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP