At a glance
ClinicalIndex Comparison Record- ✓English- or Spanish-speaking
- ✓Age 18 years or older
- ✓Estimated gestational age up to 70 days from last menstrual period (LMP)
- ✓Seeking medical abortion
- ✕Age under 18 years
- ✕Estimated gestational age greater than 70 days from LMP at enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Is Transabdominal Sonography Comparable to Transvaginal Sonography for Eligibility Assessment Prior to Medical Abortion? A Randomized Controlled Trial.
In Brief
A clinical study evaluating Transabdominal sonography and Transvaginal sonography for Abortion Early. Completed, enrolled 634 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.