Objective: To evaluate the ability of women and their providers to assess abortion outcome without the routine use of ultrasonography.
Methods: This multicenter trial enrolled 4,484 women seeking medical abortion at 10 clinics in the United States. Women received the standard medical abortion care with mifepristone-misoprostol in those clinics and blinded clinical assessments before follow-up ultrasonography. Data were collected prospectively on abortion outcomes, receipt of additional treatment, and clinical, laboratory, and ultrasound assessments associated with the procedure. We constructed five model algorithms for evaluating women's postabortion status, each using a different assortment of data. Four of the algorithms (algorithms 1-4) rely on data collected by the woman and on the results of the low-sensitivity pregnancy test. Algorithm 5 relies on the woman's assessment, the results of the pregnancy test, and follow-up physician assessment (sometimes including bimanual or speculum examination).
Results: A total of 3,054 women received medical abortion and had adequate data for evaluation. Twenty women (0.7%) had an ongoing pregnancy; 26 (0.9%) received curettage for retained tissue, empiric treatment for possible infection, or both; and 55 (1.8%) received additional uterotonics or other medical abortion-related care. Screening algorithms including patient-observed outcomes, a low-sensitivity pregnancy test, and nonsonographic clinical evaluation were as effective as sonography in identifying women who received interventions at or after the follow-up visit.
Conclusion: Relying on women's observations, a low-sensitivity pregnancy test, and clinical examination, women and their providers can accurately assess whether follow-up care is required after medical abortion without routine ultrasonography.
Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00120224.
Level of evidence: II.