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