The aim of this study was to ascertain any potential link between threatened miscarriage and obstetric outcome. Threatened miscarriage was associated independently with an increased incidence of abruption (OR 2.8, 2.0-3.7), unexplained antepartum haemorrhage (APH) (OR 2.3, 1.1-5.1) and preterm delivery (OR 2.0, 1.3-3.3). The incidence of low and very low birth weight deliveries, although significantly higher compared with the control population, was not affected independently by this early pregnancy complication on logistic regression (OR 1.3, 0.8-1.9). The early neonatal mortality rates were significantly higher in the threatened miscarriage group, which on logistic regression was due independently to preterm delivery, placental abruption and low birth weight deliveries. All forms of APH were significantly higher in term deliveries complicated by threatened miscarriage. Pregnancies presenting with threatened miscarriage should be highlighted as 'high risk' for a suboptimal obstetric outcome and a prospective observational trial followed by a randomised-controlled trial may be needed to establish whether the need exists for increased feto-maternal surveillance in this cohort of women.
BACKGROUNDUntil recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited. METHODSWe performed a pragmatic, noninferiority, randomized trial comparing minislings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points. RESULTSA total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], −2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, −1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group. CONCLUSIONSSingle-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up.
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