RCT for Women With a Persisting Pregnancy of Unknown Location

NCT01800162 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 815013
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Persistent Pregnancy of Unknown Location; Ectopic Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of Ruptured Ectopic Pregnancies in Each Group

  Outcome will be assess within 6 weeks of randomization

• Quantification of Re-interventions Needed to Manage a Woman With a PPUL

  6 weeks

• Treatment Complications and Adverse Events

  42 days after the last dose of study medication

• Number of Procedures (Lab Tests, Ultrasounds)

  6 weeks

• Number of Visits

  6 weeks

Study Arms (3)

Uterine evacuation, then MTX for some

ACTIVE COMPARATOR

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.

Drug: Methotrexate; Procedure: Uterine Evacuation

Empiric treatment with MTX for all

ACTIVE COMPARATOR

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.

Drug: Methotrexate

Expectant Management

ACTIVE COMPARATOR

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

Other: Expectant Management

Interventions

Methotrexate DRUG

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.

Empiric treatment with MTX for all; Uterine evacuation, then MTX for some

Uterine Evacuation PROCEDURE

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.

Uterine evacuation, then MTX for some

Expectant Management OTHER

Pregnancy will be expectantly managed using serum hcg monitoring.

Expectant Management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female with a persisting pregnancy of unknown location:
• 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)
• 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.)
• Patient is hemodynamically stable, hemoglobin greater than 10 mg/dL,
• Greater than or 18 years of age

You may not qualify if:

• Hemodynamically unstable in need of acute treatment
• Most recent hCG greater than 5000 IU/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,
• Presence of clinical contraindications for treatment with methotrexate (ACOG guidelines, Appendix B),
• Prior medical or surgical management of this gestation.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Greenville Hospital System University Medical Center

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Methotrexate; Watchful Waiting

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Results Point of Contact

• Title: Dr. Kurt Barnhart
• Organization: University of Pennsylvania

KBarnhart@uphs.upenn.edu

215-662-2974

Study Officials

• Kurt T Barnhart, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: February 27, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 29, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-12

Locations

US (2)