Clinical trialNCT02152696CompletedPhase 3Interventional

Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

SponsorYale UniversityEnrollment255Ectopic PregnancyPersistent Pregnancy of Unknown Location

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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 3) Expectant management. Randomization will be 1:1:1 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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Anne Steiner, MD MPH
University of North Carolina
Study Director
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Christos Coutifaris, MD PhD
University of Pennsylvania
Study Director
clinicaltrials.gov ↗
Esther Eisenberg, MD MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director
clinicaltrials.gov ↗
Heping Zhang, PhD
Yale University
Study Director
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Karl Hansen, MD PhD
University of Oklahoma
Study Director
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Kurt Barnhart, MD MSCE
University of Pennsylvania
Principal Investigator
clinicaltrials.gov ↗
Marcelle Cedars, MD
University of California, San Francisco
Study Director
clinicaltrials.gov ↗
Michael Diamond, MD
Augusta University
Study Director
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Nanette Santoro, MD
University of Colorado, Denver
Study Chair
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Richard Legro, MD
Penn State University
Study Director
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California San Francisco
San Francisco, California, United States
Denver Health
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of South Florida
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Wayne State University
Southfield, Michigan, United States
Washington University
St Louis, Missouri, United States
University of Rochester
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Carolinas Medical Center - Women'S Institute
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Greenville Health System
Greenville, South Carolina, United States
University of Utah
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Methotrexate →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 25 Jul 2014
Primary completion: 31 Aug 2019
Completion: 19 Aug 2019
Last update posted: 8 Dec 2020
Registered enrollment: 255
Registry id: NCT02152696

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.