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3 result(s) for "Merced, Carme"
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Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial
Most previous studies of the use of cervical pessaries were either retrospective or case controlled and their results showed that this intervention might be a preventive strategy for women at risk of preterm birth; no randomised controlled trials have been undertaken. We therefore undertook a randomised, controlled trial to investigate whether the insertion of a cervical pessary in women with a short cervix identified by use of routine transvaginal scanning at 20–23 weeks of gestation reduces the rate of early preterm delivery. The Pesario Cervical para Evitar Prematuridad (PECEP) trial was undertaken in five hospitals in Spain. Pregnant women (aged 18–43 years) with a cervical length of 25 mm or less were randomly assigned according to a computer-generated allocation sequence by use of central telephone in a 1:1 ratio to the cervical pessary or expectant management (without a cervical pessary) group. Because of the nature of the intervention, this study was not masked. The primary outcome was spontaneous delivery before 34 weeks of gestation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00706264. 385 pregnant women with a short cervix were assigned to the pessary (n=192) and expectant management groups (n=193), and 190 were analysed in each group. Spontaneous delivery before 34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (12 [6%] vs 51 [27%], odds ratio 0·18, 95% CI 0·08–0·37; p<0·0001). No serious adverse effects associated with the use of a cervical pessary were reported. Cervical pessary use could prevent preterm birth in a population of appropriately selected at-risk women previously screened for cervical length assessment at the midtrimester scan. Instituto Carlos III.
Evaluation of an Alternative Screening Method for Gestational Diabetes Diagnosis During the COVID-19 Pandemic (DIABECOVID STUDY): An Observational Cohort Study
Background: To evaluate the impact of applying alternative diagnostic criteria for gestational diabetes mellitus (GDM) during the COVID-19 pandemic on GDM prevalence, obstetrical and perinatal outcomes, and costs, as compared to the standard diagnostic method. Methods: A cohort of pregnant individuals undergoing GMD screening with the alternative GDM method, which uses plasma glucose (fasting or non-fasting) and HbA1c, was compared with a cohort of pregnant individuals undergoing the standard GDM screening method. Both cohorts were obtained from six hospitals across Catalonia, Spain, from April 2020 to April 2022. The primary outcome was large for gestational age rate at birth. The secondary outcomes were composite adverse outcomes, including pregnancy complications, delivery complications, and neonatal complications. The cost differences between screening methods were also evaluated. A similar analysis was performed in the subgroup diagnosed with GDM. Results: Data were collected from 1543 pregnant individuals in the standard screening group and 2197 in the alternative screening group. The standard screening group had a higher GDM diagnostic rate than the alternative screening group (10.8% vs. 6.9%, respectively; p < 0.0001). The primary outcome (large for gestational age rate) was similar between groups: 200/1543 (13.0%) vs. 303/2197 (13.8%). The adjusted OR for this outcome was 1.74 (95% CI: 0.74–4.10). An adjusted analysis showed no differences between groups in the composite adverse outcomes for pregnancy complications (OR: 1.11; 95% CI: 0.91–1.36), delivery complications (OR: 0.95; 95% CI: 0.75–1.19), and neonatal complications (OR: 1.28; 95% CI: 0.94–1.75). Among individuals diagnosed with GDM, the large for gestational age rate was similar between groups: 13/166 (7.8%) vs. 15/151 (9.9%). The OR adjusted for this outcome was 1.24 (95% CI: 0.51–3.09). An adjusted analysis showed no differences in the composite adverse outcomes for pregnancy complications (OR: 1.57; 95% CI: 0.84–2.98), delivery complications (OR: 1.21; 95% CI: 0.63–2.35), and neonatal complications (OR: 1.35; 95% CI: 0.61–3.04). The mean cost (which included expenses for consumables, equipment, and personnel) of the alternative screening method was 46.0 euros (22.3 SD), as compared to 85.6 euros (67.5 SD) for the standard screening method. Conclusions: In this Spanish population during the COVID-19 pandemic, GDM prevalence was lower in the alternative screening group than in the standard screening group. After adjusting for GDM risk factors, outcomes related to obstetrics, delivery, and neonatal complications were comparable between both groups. Finally, the alternative screening method was cheaper than the standard screening method.