Current pregnancy among women with spinal cord injury: findings from the US national spinal cord injury database.

STUDY DESIGN: Cross-sectional study. OBJECTIVES: To examine the prevalence of pregnancy and associations with sociodemographic and clinical factors among women with spinal cord injury (SCI). SETTING: US National Spinal Cord Injury Database, an SCI registry that interviews participants 1, 5 and then every 5 years post injury. Data include SCI clinical details, functional impairments, participation measures, depressive symptoms and life satisfaction. Women aged 18-49 are asked about hospitalizations in the last year relating to pregnancy or its complications. Data represent 1907 women, who completed 3054 interviews. METHODS: We used generalized estimating equations to examine bivariable associations between pregnancy and clinical and psychosocial variables and to perform multivariable regressions predicting pregnancy. RESULTS: Across all women, 2.0% reported pregnancy during the prior 12 months. This annual prevalence differed significantly by the years elapsed since injury; the highest rate occurred 15 years post injury (3.7%). Bivariable analyses found that younger age at injury was significantly associated with current pregnancy (P<0.0001). Compared with nonpregnant women, those reporting current pregnancy were significantly more likely to be married or partnered, have sport-related SCI, have higher motor scores and have more positive psychosocial status scores. Multivariable analyses found significant associations between current pregnancy and age, marital status, motor score and mobility and occupation scale scores. CONCLUSION: Current pregnancy rates among reproductive-aged women with SCI are similar to rates of other US women with chronic mobility impairments. More information is needed about pregnancy experiences and outcomes to inform both women with SCI seeking childbearing and clinicians providing their care.

Two phase 3, multicenter, randomized, placebo-controlled clinical trials of fampridine-SR for treatment of spasticity in chronic spinal cord injury.

STUDY DESIGN: Two randomized, double-blind, placebo-controlled trials. OBJECTIVE: To evaluate the efficacy and safety of fampridine sustained-release tablets (fampridine-SR) 25 mg twice daily for moderate-to-severe spasticity in patients with chronic spinal cord injury (SCI). SETTING: United States and Canada. METHODS: Patients with incomplete chronic SCI were randomized to twice daily fampridine-SR 25 mg or placebo, with a 2-week single-blind placebo run-in, a 2-week titration, 12 weeks of stable dosing, 2 weeks of downward titration and 2 weeks of untreated follow-up. Co-primary end points were the change from baseline, averaged over the double-blind treatment period, for Ashworth score (bilateral knee flexors and extensors) and a 7-point Subject Global Impression of treatment (SGI; 1, terrible; 7, delighted). Secondary end points were: Penn Spasm Frequency Scale; the motor/sensory score from the International Standards for Neurological Classification of SCI; Clinician's Global Impression of Change of neurological status; and the International Index of Erectile Function (men) or the Female Sexual Function Index (women). RESULTS: The populations were 212 and 203 patients in the two studies, respectively. Changes from baseline in Ashworth score were -0.15 (placebo) and -0.19 (fampridine-SR) in the first study, and -0.16 (placebo) and -0.28 (fampridine-SR) in the second study. The between-treatment difference was not significant for either the Ashworth score or the SGI and, with few exceptions, neither were the secondary end points. Fampridine-SR was generally well tolerated; treatment-emergent adverse events (TEAEs) and serious TEAEs were reported with similar frequency between treatments. CONCLUSION: Fampridine-SR was well tolerated. No significant differences were observed between treatment groups for the primary end points of Ashworth score and SGI.