RCT for Women With a Persisting Pregnancy of Unknown Location

Stopped early · Phase 1/Phase 2

Conditions studied: Persistent Pregnancy of Unknown Location, Ectopic Pregnancy

In brief

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.

Key facts

Study ID

NCT01800162

Run by

University of Pennsylvania

People needed

2

Starts

2013-02-01

Expected to finish

2013-12-01

Last updated by the study team

2017-12-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Greenville Hospital System University Medical Center — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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