NCT01800162

RCT for Women With a Persisting Pregnancy of Unknown Location

Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location -- a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Pregnancy of Unknown Location
• Ectopic Pregnancy

Interventions

Type	Name	Description
DRUG	Methotrexate	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.
PROCEDURE	Uterine Evacuation	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.
OTHER	Expectant Management	Pregnancy will be expectantly managed using serum hcg monitoring.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-02-27
• Last updated: 2017-12-29
• Results posted: 2017-05-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study