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NCT01800162 · ClinicalTrials.gov registry record · Phase 1
RCT for Women With a Persisting Pregnancy of Unknown Location
A Phase 1 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01800162: Clinical Trial Phase 1 study, sponsored by University of Pennsylvania.
NCT01800162 is a Phase 1 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01800162, a Phase 1 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- DRUG Methotrexate
- OTHER Expectant Management
- PROCEDURE Uterine Evacuation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01800162
The ClinicalTrials.gov registry entry for NCT01800162 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Methotrexate is the first listed.
NCT01800162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01800162 about?
NCT01800162 is a clinical study titled "RCT for Women With a Persisting Pregnancy of Unknown Location". 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 on...
What is the current status of trial NCT01800162?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2013-02. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01800162?
The interventions under investigation include: Methotrexate (DRUG), Expectant Management (OTHER), Uterine Evacuation (PROCEDURE).
Who is sponsoring clinical trial NCT01800162?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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