Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery. METHODS: A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management. The primary effectiveness endpoint was the presence of full LAM avulsion on transperineal pelvic-floor ultrasound at 3 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months. RESULTS: A total of 214 women were randomized to Device (n = 113) or Control (n = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 110 participants, 46 Device subjects who received full device treatment, and 64 Controls underwent ultrasound for the per-protocol analysis. No full LAM avulsions (0.0%) occurred in the Device group versus 7 out of 64 (10.9%) in the Control group (p = 0.040; two-tailed Fisher's test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related. CONCLUSIONS: The pelvic floor dilator device significantly reduced the incidence of complete LAM avulsion in nulliparous individuals undergoing first vaginal childbirth. The dilator demonstrated an acceptable safety profile and was well received by recipients. Use of the intrapartum electromechanical pelvic floor dilator in laboring nulliparous individuals may reduce the rate of LAM avulsion, an injury associated with serious sequelae including pelvic organ prolapse.

Clinical performance characteristics of the adiana® system for permanent contraception: the first year of commercial use.

In 2009, the Adiana® System for Permanent Contraception was approved by the US Food and Drug Administration and became the second device on the market for hysteroscopic sterilization. This article outlines the basics of the Adiana procedure as it relates to the initial 12-month clinical experience following commercial launch. Safety, efficacy, and practical applications are explored to provide a better understanding of product performance characteristics in the first year of actual clinical use.

Prophylactic antibiotics for non-laboring patients with intact membranes undergoing cesarean delivery: an economic analysis.

OBJECTIVE: We conducted an economic analysis of prophylactic antibiotic administration for elective cesarean delivery. STUDY DESIGN: We created a decision tree comparing the use of prophylactic antibiotics (cefazolin 1 gm intravenous) with no antibiotic use. We modeled the potential for anaphylaxis, and included outcomes of fever and endometritis. Outcome probabilities and effectiveness of antibiotic administration were derived from published sources. Costs are 2001 estimates derived from our hospital's accounting system. Sensitivity analyses were performed over the range of actual patient costs and 95% CI of the risk and probability estimates. RESULTS: Cost of an uncomplicated elective cesarean delivery was $1638.57. Fever evaluation added $125.91. Elective procedure complicated by endometritis cost $2327.29. Cefazolin administration cost $1.01. The following estimates were used: relative risk (RR) of endometritis with antibiotics was 0.18 (95% CI 0.07-0.45), fever 0.47 (95% CI 0.32-0.68), risk of endometritis without prophylaxis 4.8% (95% CI 0.9%-43%), and fever without prophylaxis 14.4% (95% CI 4%-33%). Cost of an average case without prophylaxis was $1683.72; prophylaxis reduced this to $1653.06. Sensitivity analysis over the ranges above still yielded cost savings. CONCLUSION: Administration of prophylactic antibiotics for elective cesarean delivery reduced costs by $30.66 per case, approximately 2% of the total cost. Prophylactic antibiotic administration results in cost savings for elective cesarean delivery.