Back to resultsRCT for Women With a Persisting Pregnancy of Unknown Location (PPUL)
Primary Purpose
Persistent Pregnancy of Unknown Location, Ectopic Pregnancy
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methotrexate
Uterine Evacuation
Expectant Management
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Pregnancy of Unknown Location
Eligibility 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.
Sites / Locations
- University of Pennsylvania
- Greenville Hospital System University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Uterine evacuation, then MTX for some
Empiric treatment with MTX for all
Expectant Management
Arm Description
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.
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.
Subjects will have their PPUL expectantly managed using serum hCG monitoring.
Outcomes
Primary Outcome Measures
Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.
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
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
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
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)
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
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
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
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
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
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.
Full Information
NCT ID
NCT01800162
First Posted
February 25, 2013
Last Updated
December 5, 2017
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01800162
Brief Title
RCT for Women With a Persisting Pregnancy of Unknown Location
Acronym
PPUL
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
A new protocol was written to replace this protocol.
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Pregnancy of Unknown Location, Ectopic Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uterine evacuation, then MTX for some
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Empiric treatment with MTX for all
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Expectant Management
Arm Type
Active Comparator
Arm Description
Subjects will have their PPUL expectantly managed using serum hCG monitoring.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Uterine Evacuation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Expectant Management
Intervention Description
Pregnancy will be expectantly managed using serum hcg monitoring.
Primary Outcome Measure Information:
Title
Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.
Description
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 Frame
Outcome will be assessed within 6 weeks of randomization
Secondary Outcome Measure Information:
Title
Number of Ruptured Ectopic Pregnancies in Each Group
Description
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 Frame
Outcome will be assess within 6 weeks of randomization
Title
Quantification of Re-interventions Needed to Manage a Woman With a PPUL
Description
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
Time Frame
6 weeks
Title
Treatment Complications and Adverse Events
Description
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 Frame
42 days after the last dose of study medication
Title
Number of Procedures (Lab Tests, Ultrasounds)
Description
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 Frame
6 weeks
Title
Number of Visits
Description
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 Frame
6 weeks
Title
Time to Resolution
Description
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 Frame
6 weeks
Title
Patients' Preferences
Description
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 Frame
6 weeks
Title
Acceptability
Description
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 Frame
6 weeks
Title
Future Fertility
Description
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 Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt T Barnhart, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Greenville Hospital System University Medical Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
12. IPD Sharing Statement
Learn more about this trial
RCT for Women With a Persisting Pregnancy of Unknown Location
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