Ultrasound use in the assessment of medical abortion eligibility varies by practice site. The National Abortion Federation (NAF), the Society of Family Planning (SFP), and the World Health Organization (WHO) guidelines do not recommend the routine use of ultrasonography; however, many institutions and practices still require this as part of clinic protocol. Furthermore, many clinicians routinely perform transvaginal sonography (TVS), a more invasive assessment than transabdominal ultrasound (TAS). Reliance on ultrasound in general, and TVS specifically, decreases access to medical abortion by requiring facilities to purchase and maintain an ultrasound machine, employ trained staff, and perform high-level disinfection (HLD) between examinations. Studies have investigated ways to improve access to medical abortion through a variety of approaches to simplifying care and removing barriers in a variety of practice settings.
Our project takes a health services research approach to simplifying medical abortion. We will perform a multicenter, randomized controlled trial in practices that routinely use TVS to compare how often clinicians order additional testing prior to medical abortion after the use of either TVS or TAS to assess medical abortion eligibility. We plan to study providers of different clinical backgrounds and in different clinical settings. We anticipate enrolling approximately 800 patients receiving care from about 30 providers over 6-8 months. Clinicians who routinely provide medical abortion with TVS at Columbia University Medical Center (CUMC) and Planned Parenthood of Central and Greater Northern New Jersey (PPCGNNJ) will participate.
Women who present for medical abortion will be eligible for this study, and will undergo a routine evaluation including relevant history, abdominal examination, and randomization to receive either TVS or TAS. Following evaluation, providers will make a clinical decision regarding the patient’s eligibility for medical abortion, and will proceed with usual care. We will evaluate the proportion of women in the TVS and TAS groups for whom providers ordered additional testing or additional visits prior to making a decision regarding eligibility.
Our primary study outcome will be the proportion of women whose clinician orders additional evaluation after sonography and prior to determination of medical abortion eligibility. We hypothesize this proportion will be greater among those randomized to TAS (non-inferiority boundary of 80%). That is, if clinicians order additional testing in less than 20% of women undergoing TAS, we will consider TAS to be non-inferior to TVS.
Our second major outcome will be patient satisfaction after ultrasound examination. We hypothesize satisfaction will be greater among those randomized to TAS. Following study activities, each participant will complete a satisfaction questionnaire regarding the type of ultrasound she received (TVS or TAS) using a visual analog scale (VAS) and be asked, if she were to require an ultrasound in the future, which she would prefer.
The results from this study could demonstrate that when TAS is used, clinicians order additional testing in a greater proportion of patients than when TVS is used. However, we hypothesize this difference in proportions will fall within a non-inferiority boundary of 80%. Although we expect a difference, we anticipate that this difference in proportions will not be so large that using TAS instead of TVS will be burdensome to providers, clinics, or patients. Many providers in the US already have TVS capabilities and HLD, and may desire to continue using this tool. For such providers, however, switching from TVS to TAS for most patients could reduce costs and increase patient satisfaction. For potential providers who do not have TVS capabilities, our results will help to estimate how often TAS would be sufficient to provide care versus how often patients might need a referral for additional testing.
This is a combined project with another fellow at Columbia University, Caitlin Weber, MD.