Clinical trial NCT01800162: RCT 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Persistent Pregnancy of Unknown Location
Ectopic Pregnancy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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, and 3) Expectant management. Randomization will be 2:2:1 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. Secondary outcome measures: re-interventions, treatment complications, health-related quality of life, financial costs, future fertility, and patient's preferences.


Eligibility criteria: Inclusion Criteria:

1. Female with a persisting pregnancy of unknown location:

   1. A pregnancy of unknown location is defined as a women with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging (Ultrasound must be performed within 7 days prior to randomization)
   2. Persistence of hCG is defined as 3 serial hCG values over 4-14 days or 2 serial hCG values over 7-14 days, showing less than 30% rise, or less than 30% fall between the first and last value. (This abnormal pattern of serial hCG confirms that the gestation is nonviable.)
2. Patient is hemodynamically stable, hemoglobin greater than 10 mg/dL,
3. Greater than or 18 years of age

Exclusion Criteria:

1. Hemodynamically unstable in need of acute treatment
2. Most recent hCG greater than 5000 IU/mL
3. Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion),
4. Diagnosis of gestational trophoblastic disease,
5. Subject unwilling or unable to comply with study procedures,
6. Presence of clinical contraindications for treatment with methotrexate (ACOG guidelines, Appendix B),
7. Prior medical or surgical management of this gestation.

Primary outcomes:
measure: Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.
timeFrame: Outcome will be assessed within 6 weeks of randomization
Secondary outcomes:
measure: Number of Ruptured Ectopic Pregnancies in Each Group
timeFrame: Outcome will be assess within 6 weeks of randomization
measure: Quantification of Re-interventions Needed to Manage a Woman With a PPUL
timeFrame: 6 weeks
measure: Treatment Complications and Adverse Events
timeFrame: 42 days after the last dose of study medication
measure: Number of Procedures (Lab Tests, Ultrasounds)
timeFrame: 6 weeks
measure: Number of Visits
timeFrame: 6 weeks
measure: Time to Resolution
timeFrame: 6 weeks
measure: Patients' Preferences
timeFrame: 6 weeks
measure: Acceptability
timeFrame: 6 weeks
measure: Future Fertility
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System University Medical Center
state: South Carolina
Study officials:
affiliation: University of Pennsylvania
name: Kurt T Barnhart, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: