Skip to main content
OpenTrials
Completed

NCT Number: NCT02152696

Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Persistent Pregnancy of Unknown Location Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of California San Francisco, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Expectant Management

Other

Pregnancy will be expectantly managed using serum hcg monitoring

Primary outcomes

  1. Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy

    Time frame: 6 weeks from randomization

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • 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

Registry information

Official study 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

Acronym: ACTorNOT

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2014
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.