Transabdominal and Transvaginal Sonography in Medical Abortion
Completed · Not applicable
Conditions studied: Abortion Early
In brief
The investigator will perform a multicenter, randomized controlled trial in practices that routinely use transvaginal sonography (TVS) to compare how often clinicians order additional testing prior to medical abortion after the use of either TVS or transabdominal ultrasound (TAS) in medical abortion eligibility assessment. Women will be randomized to receive either TVS or TAS prior to medical abortion. We anticipate enrolling 800 patients receiving care from about 30 providers over 6-8 months. The primary study outcome will be the proportion of women that requires additional evaluation after sonography, prior to determination of medical abortion eligibility. The second primary outcome will be patient satisfaction, determined by a patient satisfaction questionnaire utilizing a visual analog scale.
Key facts
- Study ID
- NCT03047551
- Run by
- Columbia University
- People needed
- 634
- Starts
- 2016-07-01
- Expected to finish
- 2018-06-01
- Last updated by the study team
- 2019-09-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- English- or Spanish- speaking women seeking medical abortion
- 18 years or older
- Women at an estimated gestational age up to 70 days from last menstrual period (LMP)
You may not qualify if…
- Women under 18 years old
- Women at an estimated gestational age greater than 70 days from LMP at enrollment
Where it is running
- Planned Parenthood of Northern, Central, and Southern New Jersey — Morristown, New Jersey, United States
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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