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Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

NCT ID: NCT02152696

Last Updated: 2020-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-25

Study Completion Date

2019-08-19

Brief Summary

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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.

Detailed Description

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Conditions

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Persistent Pregnancy of Unknown Location Ectopic Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Expectant Management

Subjects will have their PPUL expectantly managed using serum hCG monitoring.

Group Type ACTIVE_COMPARATOR

Expectant Management

Intervention Type OTHER

Pregnancy will be expectantly managed using serum hcg monitoring

Uterine evacuation with MTX for some

Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

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.

Uterine Evacuation

Intervention Type PROCEDURE

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.

Empiric treatment with MTX for all

Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Expectant Management

Pregnancy will be expectantly managed using serum hcg monitoring

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Eisenberg, MD MPH

Role: STUDY_DIRECTOR

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

Nanette Santoro, MD

Role: STUDY_CHAIR

University of Colorado, Denver

Kurt Barnhart, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Michael Diamond, MD

Role: STUDY_DIRECTOR

Augusta University

Richard Legro, MD

Role: STUDY_DIRECTOR

Penn State University

Marcelle Cedars, MD

Role: STUDY_DIRECTOR

University of California, San Francisco

Anne Steiner, MD MPH

Role: STUDY_DIRECTOR

University of North Carolina

Karl Hansen, MD PhD

Role: STUDY_DIRECTOR

University of Oklahoma

Christos Coutifaris, MD PhD

Role: STUDY_DIRECTOR

University of Pennsylvania

Heping Zhang, PhD

Role: STUDY_DIRECTOR

Yale University

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Denver Health

Denver, Colorado, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Augusta University

Augusta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

University Of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Wayne State University

Southfield, Michigan, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Carolinas Medical Center - Women's Institute

Charlotte, North Carolina, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Greenville Health System

Greenville, South Carolina, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Barnhart KT, Hansen KR, Stephenson MD, Usadi R, Steiner AZ, Cedars MI, Jungheim ES, Hoeger KM, Krawetz SA, Mills B, Alston M, Coutifaris C, Senapati S, Sonalkar S, Diamond MP, Wild RA, Rosen M, Sammel MD, Santoro N, Eisenberg E, Huang H, Zhang H; Reproductive Medicine Network. Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location: The ACT or NOT Randomized Clinical Trial. JAMA. 2021 Aug 3;326(5):390-400. doi: 10.1001/jama.2021.10767.

Reference Type DERIVED
PMID: 34342619 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2U10HD055925-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000023590

Identifier Type: -

Identifier Source: org_study_id