RCT for Women With a Persisting Pregnancy of Unknown Location
This study is currently recruiting participants.
Verified February 2013 by University of Pennsylvania
Sponsor:
University of Pennsylvania
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
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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:
Female with a persisting pregnancy of unknown location:
- 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
- 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.)
- Patient is hemodynamically stable, hemoglobin greater than 10 mg/dL,
- Greater than or 18 years of age
Exclusion Criteria:
- Hemodynamically unstable in need of acute treatment
- hCG greater than 5000 IU/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,
- Presence of clinical contraindications for treatment with methotrexate (ACOG guidelines, Appendix 2),
- 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 May 22, 2013