Simplified medical abortion screening: a demonstration project.

OBJECTIVES: The objectives were to evaluate the safety and acceptability of outpatient medical abortion in selected women without a pretreatment ultrasound or pelvic examination. STUDY DESIGN: We conducted a prospective case-series study to estimate the incidence of serious adverse events (death, life-threatening event, hospitalization, transfusion or any other medical problem that we judged to be significant), surgical completion of the abortion and satisfaction in women provided with medical abortion without a pretreatment ultrasound or pelvic examination. We enrolled 406 women requesting medical abortion in Moldova, Mexico and the United States. To be eligible, a woman must have been certain that her last menstrual period started within the prior 56days, have had regular menses before the pregnancy, not have used hormonal contraceptives in the prior 2months (in the United States and Mexico) or 3months (in Moldova), have no risk factors for or symptoms of ectopic pregnancy, and not have had an ultrasound or pelvic exam in this pregnancy. One site also excluded women with uterine enlargement on abdominal palpation. Each participant received mifepristone (200mg orally) and misoprostol (400 mcg sublingually in Moldova; 800 mcg buccally at all other sites) and was followed until complete abortion, defined as requiring no further treatment. RESULTS: Of the 365 (90%) participants who provided sufficient follow-up information for analysis, 347 (95%) had complete abortion without additional treatment, 5 (1%) had surgical aspiration, and 10 (3%) had extra misoprostol. Three participants (1%) had serious adverse events; these included two hospital admissions for heavy bleeding managed with aspiration and one diagnosis of persistent gestational sac 19days after enrollment. Most (317, 90%) participants were pleased with omitting the pretreatment ultrasound and pelvic exam. CONCLUSIONS: In this study, medical abortion without screening ultrasound or pelvic exam resulted in no serious adverse events that were likely to have been prevented by those tests and was highly acceptable. IMPLICATIONS: Screening for medical abortion without exam or ultrasound shows promise as a means for increasing access to this service. More research is needed to develop screening criteria that are more inclusive and simpler for clinical use.

Medical abortion: outcomes in a family medicine setting.

PURPOSE: To compare outcomes of early medical abortion with mifepristone and misoprostol in a family medicine setting and specialized reproductive health clinics. METHODS: This study used data collected from a prospective, open-label, randomized trial of oral versus buccal misoprostol efficacy. A secondary analysis was performed, evaluating efficacy, acceptability, and interventions after medication at the family medicine site compared with the 6 specialized reproductive health sites. RESULTS: Comparing data from patients in the family medicine setting (n = 116) to specialized reproductive health sites (n = 731) revealed no difference in overall efficacy (95.7% vs 93.4%; P = .351). The family medicine site used a second dose of misoprostol more frequently than the other sites (6.9% vs 2.5%; P = .018). In addition, uterine aspiration after medical abortion at the family medicine site was not used for "medically necessary" reasons whereas reproductive health clinics used it 2.6% of the time (marginally significant; P = .094). Patient satisfaction at family medicine sites was comparable to the other sites (91.2% vs 92.0%; P = .792). CONCLUSION: Medical abortion has similar efficacy and patient satisfaction when offered in a family medicine practice or at a reproductive health specialty clinic. These findings should reassure family physicians that medical abortion can be offered safely in their practices.

Early abortion in family medicine: clinical outcomes.

PURPOSE: Clinical innovations have made it more feasible to incorporate early abortion into family medicine, yet the outcomes of early abortion procedures in this setting have not been well studied. We wished to assess the outcomes of first-trimester medication and aspiration abortion procedures by family physicians. METHODS: Prospective observational cohort study conducted from August 2001 to February 2005 of 2,550 women who sought pregnancy termination in 4 clinical practices of family medicine departments and 1 private office/training site. RESULTS: The rate of successful uncomplicated procedures for medication was 96.5% (95.5%-97.1% [corrected] confidence interval [CI], 95.5%-97.0%) and for aspiration was 99.9% (CI, 99.3%-1). Adverse events and complications of medication abortions were failed procedure (ongoing pregnancy; n = 19, 1.45%); incomplete abortion (n = 16, 1.22%); hemorrhage (n = 9, 0.69%); and patient request for aspiration (n = 1, 0.08%). One (0.08%) missed ectopic pregnancy was seen among patients receiving medication. Four types of adverse outcomes were encountered with aspiration: incomplete abortion requiring re-aspiration (n = 21, 1.83%); hemorrhage during the procedure (n = 4, 0.35%); missed ectopic pregnancy (n = 3, 0.26%); and minor endometritis (n = 1, 0.09%). Missed ectopic pregnancies were successfully treated in the inpatient setting without mortality (overall hospitalization rate of 0.16 of 100). All other complications were managed within outpatient family medicine sites. Rates of complication did not vary by experience of physician or by site of care (residency vs private practice). CONCLUSIONS: Complications of medication and aspiration procedures occurred at a low rate, and most were minor and managed without incident.