Objectives

This study aimed to review clinical practice outcomes of early pregnancy loss (EPL) medical management using mifepristone and misoprostol outside of a clinical trial setting.

Study design

In this retrospective cohort study, we reviewed a deidentified database of patients who received mifepristone-misoprostol for EPL from May 2018 to May 2021 at our academic center-based clinic, which was a study site for a multicenter mifepristone-misoprostol EPL trial completed in March 2018. All patients received mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, with clinic follow-up typically scheduled within 1 week. The primary outcome was successful medical management, defined as management without the need for aspiration, and the secondary outcomes included additional interventions and indications, follow-up ultrasonography findings, and adverse events requiring treatment.

Results

We treated 90 patients with a median ultrasound-measured gestational size of 49 (range 30-80) days and median time from mifepristone to misoprostol of 24 (range 8-66) hours. Follow-up was completed in clinic by 80 (88.9%), completed remotely by five (5.6%), and not completed by five (5.6%) patients. Overall, 76 (95% CI 82.9%-96.0%) of 85 patients (89.4%) with follow-up were successfully managed without uterine aspiration. Eighty patients had initial follow-up ultrasonography interpreted as gestational sac expulsion; seven (8.8%) of these ultimately underwent aspiration, including one patient who had a previously undiagnosed cesarean scar ectopic pregnancy. Two patients had significant safety outcomes: one pelvic infection and one blood transfusion during aspiration in the patient with a cesarean scar ectopic pregnancy.

Conclusions

Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe.

Implications

Medical management of EPL with mifepristone and misoprostol is effective and safe outside of a clinical trial setting. A standardized protocol based on the best available clinical trial evidence can be used in clinical practice for the medical management of EPL.

Approximately 5.7% of blunt traumas involve cervical spine (C-spine) injuries. While spine fractures are often stable and treated non-operatively, lack of access to spine specialty care results in transfer to tertiary care facilities, placing substantial financial burden on both hospitals and patients. Thus, identifying patient and injury characteristics associated with operative treatment of C-spine fractures may help reduce over-triage.

UNLABELLED: Drains are used in plastic surgery to remove excess fluid while ameliorating complications. However, there is a paucity of evidence supporting guiding parameters on when to discontinue a drain. The aim of our study was to determine whether two of the most common parameters, drain volume 24 hours before removal or postoperative day, are valid indicators for drain removal. METHODS: A retrospective chart review was conducted for surgical operations performed by our division between July 2014 and May 2019. Of the 1308 patients, 616 had a drain and a complete record. Demographics, medical history, operative time, antibiotic use, anatomic site, donor/recipient, and complication type were recorded. Complications were defined as events that deviated from expected postoperative course or required pharmacological/procedural intervention. T-test and Chi square were used to analyze data. RESULTS: In total, 544 patients were in the no complication group, and 72 were in the complication group. The complication group patients had drains removed later than patients in the no complication group (15.7 days versus 12.5 days, P = 0.0003) and had similar final 24-hour drain volumes versus patients in the no complication group (16.7 mL versus 18.8 mL, P = 0.2548). The complication group had more operations on the pelvis (11% versus 2.1%; P = 0.000017) or thigh (8.5% versus 3.4%; P = 0.029). CONCLUSIONS: Our data suggest neither postoperative day nor 24-hour volume before drain removal are valid indicators for removal. Late removal correlates with more complications; however, persisting output leading to later removal may be predictive of an impending complication rather than delays in drain removal causing the complication.

This cohort study uses the Vizient Clinical Data Base to compare the postoperative in-hospital morbidity and mortality of surgical patients with COVID-19 infection with patients without COVID-19 infection.