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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:
University of Pennsylvania
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
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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, 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: 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 |
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:
-
Female with a persisting pregnancy of unknown location:
- 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)
- 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.)
- 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
- Most recent 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 B),
- Prior medical or surgical management of this gestation.
Contacts and Locations
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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
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:
|
Cardiac Complexes, Premature Pregnancy, Ectopic Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases 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 |
ClinicalTrials.gov processed this record on September 18, 2017