RCT for Women With a Persisting Pregnancy of Unknown Location

This study is currently recruiting participants.
Verified February 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01800162
First received: February 25, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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 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: 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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 450
Study Start Date: February 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Genders 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 with no signs of pregnancy in the uterus or adnexa on ultrasound imaging
    2. Persistence of hCG is defined as at least 3 serial hCG values (over 4-14 days), with the last 3 values with less than 30% rise, or less than 30% fall. (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. 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 2),
  7. Prior medical or surgical management of this gestation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01800162

Contacts
Contact: Ashley Singer Ashley.Singer@uphs.upenn.edu

Locations
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
Netherlands
University of Amsterdam Not yet recruiting
Amsterdam, Netherlands
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01800162     History of Changes
Other Study ID Numbers: 815013
Study First Received: February 25, 2013
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Therapeutic Uses
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 April 17, 2014