Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

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 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.

Conditions

• Persistent Pregnancy of Unknown Location
• Ectopic Pregnancy

Interventions

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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Augusta University

  collaborator OTHER

• Penn State University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Yale University

  lead OTHER

Principal Investigators

• Esther Eisenberg, MD MPH · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

• Nanette Santoro, MD · University of Colorado, Denver

• Kurt Barnhart, MD MSCE · University of Pennsylvania

• Michael Diamond, MD · Augusta University

• Richard Legro, MD · Penn State University

• Marcelle Cedars, MD · University of California, San Francisco

• Anne Steiner, MD MPH · University of North Carolina

• Karl Hansen, MD PhD · University of Oklahoma

• Christos Coutifaris, MD PhD · University of Pennsylvania

• Heping Zhang, PhD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-25

Primary Completion

2019-08-31

Completion

2019-08-19

Countries

• United States

Study Locations