RCT for Women With a Persisting Pregnancy of Unknown Location (PPUL)

University of Pennsylvania

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Ectopic Pregnancy; Persistent Pregnancy of Unknown Location

Treatments: Other: Expectant Management; Procedure: Uterine Evacuation; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT01800162

815013

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 3 patient groups

Uterine evacuation, then MTX for some

Active Comparator group

Description:

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.

Treatment:

Procedure: Uterine Evacuation

Drug: Methotrexate

Empiric treatment with MTX for all

Active Comparator group

Description:

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.

Treatment:

Drug: Methotrexate

Expectant Management

Active Comparator group

Description:

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

Treatment:

Other: Expectant Management