N/A
N=634
Transabdominal and Transvaginal Sonography in Medical Abortion
Abortion Early
Bottom Line
View on ClinicalTrials.gov: NCT03047551 ↗Enrolled (actual)
634
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Percentage of Subjects in Each Ultrasound Group With Additional Testing — 63; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transabdominal sonography (Procedure); Transvaginal sonography (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects in Each Ultrasound Group With Additional Testing |
63; 14 | — |
| PRIMARY Visual Analog Scale (VAS) Score for Patient Acceptability for Either Modality of Ultrasound |
95.9; 90.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- Women under 18 years old
- Women at an estimated gestational age greater than 70 days from LMP at enrollment
Data sourced from ClinicalTrials.gov (NCT03047551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.