RCT for Women With a Persisting Pregnancy of Unknown Location

Phase 1

Terminated

• Conditions: Persistent Pregnancy of Unknown Location; Ectopic Pregnancy
• Interventions: Other: Expectant Management; Drug: Methotrexate; Procedure: Uterine Evacuation

• Registration Number: NCT01800162
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-27
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2017-03-22
• Results First Submitted QC: 2017-05-02
• Results First Posted: 2017-05-15
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uterine evacuation, then MTX for some	Uterine Evacuation	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.
Expectant Management	Expectant Management	Subjects will have their PPUL expectantly managed using serum hCG monitoring.
Uterine evacuation, then MTX for some	Methotrexate	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.
Empiric treatment with MTX for all	Methotrexate	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.

Primary Outcome Measures

Name	Time	Method
Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.	Outcome will be assessed within 6 weeks of randomization	Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Secondary Outcome Measures

Name	Time	Method
Time to Resolution	6 weeks	Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
Patients' Preferences	6 weeks	Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
Treatment Complications and Adverse Events	42 days after the last dose of study medication	Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
Number of Procedures (Lab Tests, Ultrasounds)	6 weeks	Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
Number of Visits	6 weeks	Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
Acceptability	6 weeks	Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
Number of Ruptured Ectopic Pregnancies in Each Group	Outcome will be assess within 6 weeks of randomization	Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
Quantification of Re-interventions Needed to Manage a Woman With a PPUL	6 weeks	Outcomes include: * number of interventions beyond that of intended initial strategy in each group; * additional number of MTX injections; * additional surgical procedures; * uterine evacuation (or dilation and curettage); * laparoscopy; * laparotomy
Future Fertility	6 weeks	Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Trial Locations

Locations (2)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Greenville Hospital System University Medical Center; 🇺🇸 Greenville, South Carolina, United States