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RCT for Women With a Persisting Pregnancy of Unknown Location (PPUL)

This study has been terminated.
(A new protocol was written to replace this protocol.)
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01800162
First received: February 25, 2013
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Persistent Pregnancy of Unknown Location
Ectopic Pregnancy
Drug: Methotrexate
Procedure: Uterine Evacuation
Other: Expectant Management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL. [ Time Frame: Outcome will be assessed within 6 weeks of randomization ]
    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.


Secondary Outcome Measures:
  • Number of Ruptured Ectopic Pregnancies in Each Group [ Time Frame: 6 weeks ]
    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.

  • Quantification of Re-interventions Needed to Manage a Woman With a PPUL [ Time Frame: 6 weeks ]

    Outcomes include:

    • number of interventions beyond that of intended initial strategy in each group

      • additional number of MTX injections
      • additional surgical procedures
    • uterine evacuation (or dilation and curettage)
    • laparoscopy
    • laparotomy

  • Treatment Complications and Adverse Events [ Time Frame: 42 days after the last dose of study medication ]
    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.

  • Number of Procedures (Lab Tests, Ultrasounds) [ Time Frame: 6 weeks ]
    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.

  • Number of Visits [ Time Frame: 6 weeks ]
    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.

  • Time to Resolution [ Time Frame: 6 weeks ]
    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.

  • Patients' Preferences [ Time Frame: 6 weeks ]
    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.

  • Acceptability [ Time Frame: 6 weeks ]
    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.

  • Future Fertility [ Time Frame: 6 weeks ]
    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.


Enrollment: 2
Study Start Date: February 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Uterine evacuation, then 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.
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.

  Eligibility

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

Inclusion Criteria:

  1. Female with a persisting pregnancy of unknown location:

    1. A pregnancy of unknown location is defined as a women with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging (Ultrasound must be performed within 7 days prior to randomization)
    2. Persistence of hCG is defined as 3 serial hCG values over 4-14 days or 2 serial hCG values over 7-14 days, showing less than 30% rise, or less than 30% fall between the first and last value. (This abnormal pattern of serial hCG confirms that the gestation is nonviable.)
  2. Patient is hemodynamically stable, hemoglobin greater than 10 mg/dL,
  3. Greater than or 18 years of age

Exclusion Criteria:

  1. Hemodynamically unstable in need of acute treatment
  2. Most recent hCG greater than 5000 IU/mL
  3. Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion),
  4. Diagnosis of gestational trophoblastic disease,
  5. Subject unwilling or unable to comply with study procedures,
  6. Presence of clinical contraindications for treatment with methotrexate (ACOG guidelines, Appendix B),
  7. Prior medical or surgical management of this gestation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800162

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01800162     History of Changes
Other Study ID Numbers: 815013
Study First Received: February 25, 2013
Results First Received: March 22, 2017
Last Updated: May 2, 2017

Additional relevant MeSH terms:
Pregnancy, Ectopic
Cardiac Complexes, Premature
Pregnancy Complications
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
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

ClinicalTrials.gov processed this record on May 25, 2017