Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

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Brief Title

Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

Official Title

Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location - a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy: Active Treatment Versus No Treatment

Brief 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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy


Condition

Persistent Pregnancy of Unknown Location

Intervention

Methotrexate

Study Arms / Comparison Groups

 Expectant Management
Description:  Subjects will have their PPUL expectantly managed using serum hCG monitoring.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

255

Start Date

July 25, 2014

Completion Date

August 19, 2019

Primary Completion Date

August 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Female with a persisting pregnancy of unknown location:

          -  A pregnancy of unknown location is defined as a pregnancy in a woman with a positive
             pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on
             ultrasound imaging. A definitive sign of gestation includes ultrasound visualization
             of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in
             the adnexa. Ultrasound must be performed within 7 days prior to randomization.

          -  Persistence of hCG is defined as at least 2 serial hCG values (over 2-14 days),
             showing < 15% rise per day, or < 50% fall between the first and last value.

          -  Patient is hemodynamically stable, hemoglobin >10 mg/dL

          -  Greater than or 18 years of age

        Exclusion Criteria:

          -  Hemodynamically unstable in need of acute treatment

          -  Most recent hCG > 5000 mIU/mL

          -  Patient obtaining care in relation to a recently completed pregnancy (delivery,
             spontaneous or elective abortion)

          -  Diagnosis of gestational trophoblastic disease

          -  Subject unwilling or unable to comply with study procedures

          -  Known hypersensitivity to MTX

          -  Presence of clinical contraindications for treatment with MTX

          -  Prior medical or surgical management of this gestation

          -  Subject unwilling to accept a blood transfusion
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Esther Eisenberg, MD MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02152696

Organization ID

2000023590

Secondary IDs

2U10HD055925-06

Responsible Party

Sponsor

Study Sponsor

Yale University

Collaborators

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

Study Sponsor

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


Verification Date

November 2020