European journal of obstetrics, gynecology, and reproductive biology
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Eur. J. Obstet. Gynecol. Reprod. Biol. · Dec 2011
Randomized Controlled Trial Multicenter Study Clinical TrialThe efficacy and safety of PSD503 (phenylephrine 20%, w/w) for topical application in women with stress urinary incontinence. A phase II, multicentre, double-blind, placebo controlled, 2-way cross over study.
PSD503 is a topical gel containing phenylephrine 20% weight/weight (w/w) intended for vaginal application close to the area of the urethral sphincter in women with SUI and has been used in patients with faecal incontinence. The primary objective of this proof of concept study was to evaluate the efficacy of PSD503 in women with SUI as measured by the change in pad weight following an exercise stress pad test. The secondary objectives were to evaluate plasma concentrations of PSD503, BP changes and pulse rate over 3h following administration and to assess safety and tolerability. ⋯ This is the first proof of concept study to demonstrate that a topical α adrenergic agonist gel is rapidly and consistently absorbed vaginally and may have a role in the management of female SUI. However, since recruitment was difficult this may indicate that whilst objectively effective, acceptability in clinical practice may be poor.
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Eur. J. Obstet. Gynecol. Reprod. Biol. · Dec 2011
Randomized Controlled Trial Comparative StudyEffectiveness of pulse oximetry versus fetal electrocardiography for the intrapartum evaluation of nonreassuring fetal heart rate.
To compare the effectiveness of pulse oximetry and fetal electrocardiography in the management of labor with nonreassuring fetal heart rate (NRFHR). ⋯ Fetal electrocardiography with the STAN® 21 system was more effective in detecting good fetal status and thus in identifying cases in which labor could proceed safely. Intrapartum surveillance with the STAN® 21 system reduced the rate of emergency cesarean delivery.
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Eur. J. Obstet. Gynecol. Reprod. Biol. · Dec 2011
Tinzaparin use in pregnancy: an international, retrospective study of the safety and efficacy profile.
This study audited pregnancies where the mother received tinzaparin (at any stage before delivery), with a primary objective of determining the maternal safety of this low molecular weight heparin when administered as treatment and/or prophylaxis; the secondary objective was to audit fetal and neonatal safety in this cohort. Efficacy outcomes were also recorded. ⋯ These data provide reassuring maternal and fetal outcome information in pregnancies exposed to tinzaparin.