Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:May 2014
End Date:August 2019

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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

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.


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
We found this trial at
18
sites
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Anne Steiner, MD, MPH
Phone: 919-843-8246
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Durham, North Carolina 27710
(919) 684-8111
Phone: 919-572-7927
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Kathy Hoeger, MD
Phone: 585-273-2995
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Erica Johnstone, MD
Phone: 801-581-7038
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Shayne Plosker, MD
Phone: 813-259-0655
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Augusta, Georgia 30912
Principal Investigator: Michael Diamond, MD
Phone: 706-721-9680
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Augusta, GA
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Charlotte, North Carolina 28204
Principal Investigator: Rebecca Usadi, MD
Phone: 704-355-3834
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Charlotte, NC
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Mary Stephenson, MD
Phone: 312-355-4559
University of Illinois at Chicago A major research university in the heart of one of...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Jared Robins, MD
Phone: 312-926-8244
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Denver, Colorado 80204
Principal Investigator: Meredith Alston, MD
Phone: 303-602-9086
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Greenville, South Carolina 29615
Principal Investigator: Benjie Mills, MD
Phone: 864-455-6203
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Hershey, Pennsylvania 17033
Principal Investigator: Richard Legro, MD
Phone: 717-531-3692
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Linda Fan, MD
Phone: 203-737-4660
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Karl Hansen, MD, PhD
Phone: 405-271-1616
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-615-4890
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Saint Louis, Missouri 63110
Principal Investigator: Emily Jungheim, MD
Phone: 314-286-2458
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San Francisco, California 94143
Principal Investigator: Marcelle Cedars, MD
Phone: 415-353-4305
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Southfield, Michigan 48034
Principal Investigator: Puscheck Elizabeth, MD
Phone: 248-352-8200
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