Status:
TERMINATED
RCT for Women With a Persisting Pregnancy of Unknown Location
Lead Sponsor:
University of Pennsylvania
Conditions:
Persistent Pregnancy of Unknown Location
Ectopic Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01800162
Start Date
February 1 2013
End Date
December 1 2013
Last Update
December 29 2017
Active Locations (2)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States, 29605