RCT for Women With a Persisting Pregnancy of Unknown Location

Phase 2TerminatedNCT01800162

University of Pennsylvania2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Persistent Pregnancy of Unknown Location Ectopic Pregnancy

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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 but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging (Ultrasound must be performed within 7 days prior to randomization) 2. 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.) 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. Most recent 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 B), 7. Prior medical or surgical management of this gestation.