RCT for Women With a Persisting Pregnancy of Unknown Location

Ectopic Pregnancy Clinical Trial

— PPUL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01800162
• Other study ID #: 815013
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 25, 2013
• Last updated: December 5, 2017
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Persistent Pregnancy of Unknown Location
• Pregnancy, Ectopic

Intervention

Drug:
• Methotrexate
Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.

Procedure:
• Uterine Evacuation
Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation.

Other:
• Expectant Management
Pregnancy will be expectantly managed using serum hcg monitoring.

Locations

Country	Name	City	State
United States	Greenville Hospital System University Medical Center	Greenville	South Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.	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.	Outcome will be assessed within 6 weeks of randomization
Secondary	Number of Ruptured Ectopic Pregnancies in Each Group	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.	Outcome will be assess within 6 weeks of randomization
Secondary	Quantification of Re-interventions Needed to Manage a Woman With a PPUL	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	6 weeks
Secondary	Treatment Complications and Adverse Events	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.	42 days after the last dose of study medication
Secondary	Number of Procedures (Lab Tests, Ultrasounds)	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.	6 weeks
Secondary	Number of Visits	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.	6 weeks
Secondary	Time to Resolution	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.	6 weeks
Secondary	Patients' Preferences	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.	6 weeks
Secondary	Acceptability	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.	6 weeks
Secondary	Future Fertility	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.	6 weeks