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 2010
Multicenter StudyPrediction of peripartum hysterectomy and end organ dysfunction in major obstetric haemorrhage.
The aims of this study are to determine the incidence and aetiology of major obstetric haemorrhage (MOH) in our population, to examine the success rates of medical and surgical interventions and to identify risk factors for peripartum hysterectomy and end organ dysfunction (EOD). ⋯ MOH is complicated by hysterectomy in 24% and end organ dysfunction in 16% of cases. The risk of peripartum hysterectomy is increased with the number of previous caesarean sections, the aetiology of the bleed, namely placenta praevia/accreta or uterine rupture and the volume of blood transfused. Critically, failure to maintain optimal haematocrit during the acute event was associated with end organ dysfunction.
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Eur. J. Obstet. Gynecol. Reprod. Biol. · Mar 2010
Randomized Controlled Trial Multicenter StudyEfficacy and safety of a novel oral contraceptive based on oestradiol (oestradiol valerate/dienogest): a Phase III trial.
A novel oral contraceptive (OC) that contains oestradiol valerate (E2V; 1 mg of E2V is equivalent to 0.76 mg of 17beta-oestradiol) and dienogest (DNG) has been developed. The efficacy and safety of this formulation was assessed in the current study. ⋯ A novel OC based on oestradiol provides highly effective and reliable contraception. This is achieved through the combination of oestradiol valerate (E2V) and dienogest (DNG) administered using an oestrogen step-down and a progestin step-up approach over 26 days of active treatment followed by 2 days of placebo. The preparation is well tolerated and is associated with a high degree of user satisfaction and a low discontinuation rate.
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Eur. J. Obstet. Gynecol. Reprod. Biol. · Mar 2008
Multicenter StudyDisclosure and health-seeking behaviour following intimate partner violence before and during pregnancy in Flanders, Belgium: a survey surveillance study.
The objectives were to estimate the prevalence of physical and sexual intimate partner violence (IPV) among a regional sample of the general obstetric population as the lifetime prevalence, as the 1-year period prevalence before pregnancy, and as the prevalence during the index pregnancy; to assess the rates of disclosure and help-seeking behaviour with IPV; and to determine the acceptability of screening for IPV. ⋯ In our highly medicalised society, women experiencing partner violence rarely disclose abuse to the widely available health care services, unless they are directly asked about it, which appears an acceptable practice. Hence, there is a definite need to improve women's awareness regarding abuse and their help-seeking behaviour at a public health level.
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Eur. J. Obstet. Gynecol. Reprod. Biol. · Mar 2007
Multicenter StudyRupture of tubal pregnancy in the Vilnius population.
To evaluate the determinants of tubal rupture in women who suffered from ectopic pregnancy in relation to their demographic profile and medical history. ⋯ Our data suggest that age of > or =35 years and implantation in the straightest segment of the tube could be associated with increased rate of tubal rupture. Of particular interest is the overall tubal rupture prevalence (29.5%) observed since these women were managed in an environment where transvaginal ultrasound equipment and quantitative assessment of beta-human chorionic gonadotrophin were not routinely available.