Phase 3 N=255 Randomized Treatment

Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

Persistent Pregnancy of Unknown Location · Ectopic Pregnancy

Bottom Line

View on ClinicalTrials.gov: NCT02152696 ↗

Enrolled (actual)

255

Serious AEs

1.6%

Results posted

Oct 2020

Primary outcome: Primary: Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy — 31; 42; 45 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Methotrexate (Drug); Uterine Evacuation (Procedure); Expectant Management (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Yale University
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy	31; 42; 45	—

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.

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 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

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Data sourced from ClinicalTrials.gov (NCT02152696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.