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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). 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.
Primary Outcome
Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
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 |
Why NCT01800162 stopped before completion
NCT01800162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Methotrexate is the first listed.
NCT01800162 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01800162's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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