RCT for Women With a Persisting Pregnancy of Unknown Location
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/31/2017 |
| Start Date: | February 2013 |
| End Date: | December 2013 |
Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location -- a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy
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.
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.
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.
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