Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

Ectopic Pregnancy Clinical Trial

— ACTorNOT  

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: Active Treatment Versus No Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152696
• Other study ID #: 2000023590
• Secondary ID: 2U10HD055925-06
• Status: Completed
• Phase: Phase 3
• Start date: July 25, 2014
• Est. completion date: August 19, 2019

Study information

• Verified date: November 2020
• Source: Yale University
• 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 3) Expectant management. Randomization will be 1:1:1 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: August 19, 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female with a persisting pregnancy of unknown location:
• A pregnancy of unknown location is defined as a pregnancy in a woman with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging. A definitive sign of gestation includes ultrasound visualization of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in the adnexa. Ultrasound must be performed within 7 days prior to randomization.
• Persistence of hCG is defined as at least 2 serial hCG values (over 2-14 days), showing < 15% rise per day, or < 50% fall between the first and last value.
• Patient is hemodynamically stable, hemoglobin >10 mg/dL
• Greater than or 18 years of age

Exclusion Criteria:

• Hemodynamically unstable in need of acute treatment
• Most recent hCG > 5000 mIU/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
• Known hypersensitivity to MTX
• Presence of clinical contraindications for treatment with MTX
• Prior medical or surgical management of this gestation
• Subject unwilling to accept a blood transfusion

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	Augusta University	Augusta	Georgia
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Carolinas Medical Center - Women's Institute	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	University Of Illinois at Chicago	Chicago	Illinois
United States	Denver Health	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Greenville Health System	Greenville	South Carolina
United States	Yale University	New Haven	Connecticut
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	Washington University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	University of California San Francisco	San Francisco	California
United States	Wayne State University	Southfield	Michigan
United States	University of South Florida	Tampa	Florida

Sponsors (8)

Lead Sponsor	Collaborator
Yale University	Augusta University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of California, San Francisco, University of North Carolina, University of Oklahoma, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy	The primary outcome measure in each of each 3 treatment arm is the uneventful clinical resolution of a PPUL without change in treatment from the initial management strategy.	6 weeks from randomization