Diabetes Mellitus and lower genital tract tears after vaginal birth: A cohort study.

INTRODUCTION: Diabetes Mellitus in pregnancy is increasing. No existing studies have examined Diabetes Mellitus as the primary exposure for lower genital tract tears after vaginal birth. The objective was to study the association between Diabetes Mellitus (all types combined), Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus and Gestational Diabetes Mellitus and lower genital tract tears after vaginal birth. MATERIAL AND METHODS: A register-based cohort study of women with singleton pregnancy and without a previous cesarean section at near-term (≥ 35 + 0 weeks) and term (≥ 37 + 0 weeks) gestational age, n = 31,297 at Aarhus University Hospital, Denmark from 1 January 2004 to 31 December 2012. The associations between Diabetes Mellitus and lower genital tract tears were analysed using a fixed multiple logistic regression analyses. RESULTS: Approximately 32,000 women were eligible for the study; 796 women had diabetes (2.5%) and 1318 experienced anal sphincter injury (4.3%). The overall risk of lower genital tract tears was similar among women with a diagnosis of diabetes (Type1 Diabetes Mellitus, Type 2 Diabetes Mellitus, and Gestational Diabetes Mellitus) compared to women without diabetes, except for nulliparous women with Type1 Diabetes Mellitus who experienced a higher risk of episiotomies, crude and adjusted odds ratios (OR 2.13, 95% CI 1.14-3.97) and (OR 2.48, 95% CI 1.21-5.10), respectively. CONCLUSIONS: Women with Diabetes Mellitus without a previous cesarean section who gave birth vaginally to a single child at term or near term did not experienced an increased risk of lower genital tract tears. However, nulliparous women with Type 1 Diabetes Mellitus experienced a higher risk of episiotomy. These results may be used to individualised counselling of women with Diabetes Mellitus regarding mode of birth and may reduce worries about genital tract tears in women with Diabetes Mellitus considering vaginal birth.

The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo.

BACKGROUND: Previous gastrointestinal (GI) outcomes of nonsteroidal anti-inflammatory drug (NSAID) trials have focused on upper GI events, although recent evidence suggests NSAID-related lower GI effects are important and clinically relevant. OBJECTIVE: We assessed the long-term GI adverse event (AE) profile of celecoxib in a nonarthritis population. The aim of this post hoc analysis was to determine the incidence of serious GI AEs, using a new Clinically Significant Upper and/or Lower GI Events end point. METHODS: Patients from 2 colorectal adenoma recurrence studies were included. Patients received celecoxib 200 mg/400 mg BID, 400 mg once daily, or placebo over 3 years. The analysis measured noninferiority, using a prespecified definition of noninferiority. Celecoxib was predefined to be noninferior to placebo if the upper limit of the 95% CI for the hazard ratio (HR) with celecoxib was <1.25, at any dose, compared with the placebo (calculated using the Cox proportional hazards model). RESULTS: A total of 3588 patients were included; in the primary analysis, the HR for celecoxib (any dose) compared with placebo was 1.22 (95% CI: 0.69-2.18; P = 0.4948). In the secondary dose analyses, the HR associated with a 400-mg daily dose, compared with placebo, was 1.04 (95% CI: 0.55-1.96; P = 0.9149); for 800 mg/d, the HR was 1.79 (95% CI: 0.82-3.89; P = 0.1427). In a third covariate analysis, low-dose aspirin use (HR = 2.33; 95% CI: 1.33-4.08) and age ≥65 years (HR = 1.82; 95% CI, 1.05-3.15) was suggested to have a statistically significant association with increased risk of GI AEs. Study limitations include retrospective evaluation and small sample size of patients with GI AEs. CONCLUSIONS: The noninferiority of celecoxib to placebo was not established because the HR for the time to the first Clinically Significant Upper and/or Lower GI Event was greater than the prespecified upper limit of 95% CI for noninferiority. In addition, HRs associated with daily doses of 400 or 800 mg celecoxib compared with placebo were not significant. However, a significantly increased risk of clinically significant upper and/or lower GI events was observed in low-dose aspirin users (≤162.5 mg average daily use) and in patients ≥65 years of age.

The role of debridement and antibiotics in gunshot wounds to the spine.

BACKGROUND: The number of spinal cord injuries due to gunshot wounds continues to rise each year, and they currently rank third behind motor vehicle collisions and falls. Spine and wound infections pose difficult problems for transgastrointestinal gunshot wounds to the spine. METHODS: A retrospective review of 114 patients with low-velocity gunshot wounds to the spine was performed. Attention was paid to associated gastrointestinal (GI) tract injuries, antibiotic coverage, surgical intervention, and the development of spine and wound infections. RESULTS: Of 114 patients with gunshot wounds to the spine, 27 (23.7%) sustained a concomitant GI tract injury and 87 (76.3%) did not. Four spine infections (4/114, 3.5%) and 23 wound infections (23/114, 20.2%) developed in our patient population. Spine infection (chi = 13.36, p < 0.001) and wound infection (chi = 12.94, p < 0.001) rates were significantly higher in transgastrointestinal gunshot wounds to the spine. Surgical treatment of the spine in patients with transgastrointestinal gunshot wounds showed a significantly higher rate of spinal infection than did nonsurgical treatment of the spine (p = 0.013, Cramer's V = 0.61). No significant difference in spine infection rate was seen with adequate versus inadequate antibiotic coverage in the trans- gastrointestinal subset (p = 1.00), or in the development of wound infections with spine surgery (p = 0.628) or varying antibiotic coverage (p = 1.00). CONCLUSIONS: There is a significantly higher rate of spine and wound infections with trans-gastrointestinal gunshot wounds to the spine. These injuries, particularly those that involve the colon, put patients at risk for the development of spine infections after spinal surgery. Randomized controlled trials are necessary for the development of a specific protocol for intravenous antibiotic therapy in the setting of transgastrointestinal gunshot wounds to the spine.