Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta-analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation.

BACKGROUND: Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent. OBJECTIVES: Our hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non-adherence to these guidelines will probably contribute to its failure. SEARCH STRATEGY AND SELECTION CRITERIA: Based on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries. DATA COLLECTION AND ANALYSIS: We analyzed the implications of 14 criteria each accounting for 0-2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk-benefit ratio of medical devices. MAIN RESULTS: Seven RCTs in each singleton and twin pregnancies (5193 "cases") were included, detecting a high heterogeneity within control groups (I2 = 85% and 87%, respectively, P < 0.01). The CEP score varied from 11 to 26 points for all studies. The most common reasons for low scores and potential data compromise were poor recruitment rates, no (completed) power analysis, and no pre-registration, but mainly non-adherence to technical, biological, and clinical equivalence to the instructions for use as required by the MDR. All trials with score values greater than 20 had applied audit procedures. Within this group we found significantly reduced rates of spontaneous preterm birth at less than 34 weeks within the pessary group in singleton (odds ratio 0.28; 95% confidence interval 0.12-0.65) and twin pregnancies (odds ratio 0.30; 95% confidence interval 0.13-0.67). Similarly, there was a significant reduction in the composite poor neonatal outcome in singleton (odds ratio 0.25; 95% confidence interval 0.10-0.61) and twin pregnancies (odds ratio 0.54; 95% confidence interval 0.35-0.82) after a pessary as compared with controls. CONCLUSION: Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.

Association of social capital with mental health and quality of life among low- and high-risk pregnant women.

INTRODUCTION: Social capital means having resources and support in relationships and social ties. It can affect the individual's quality of life and mental health. The present study investigated the association between social capital with psychological status and quality of life among low-risk and high-risk pregnant women. METHODS: The present cross-sectional study was conducted with the participation of 394 pregnant women receiving prenatal care in urban comprehensive health centers in Qazvin, Iran. Two-stage sampling was used to select comprehensive health centers by random cluster sampling and then pregnant women randomly. Social capital, quality of life (QoL), psychological status, and demographic and obstetric characteristics were assessed. Uni-variable and multivariable linear regression models were used to analyze the data. RESULTS: Among the participants, 267 had low-risk pregnancies (67.77%) and the remainder were high-risk. The mean age of participants was 27.94 years (SD=5.86), the mean gestational age was 23.63 weeks (SD=7.71). The mean overall quality of life score among low-risk pregnant women was 32.00 (SD=5.27) and among high-risk pregnant women was 29.70 (SD=3.65). High-risk pregnant women experienced significantly higher anxiety and depression and fear of COVID-19. Social capital had a significant and weak relationship with anxiety among low-risk pregnant women (r = 0.22, p < 0.001). Also, a weak and significant relationship between social capital and anxiety (r = 0.24, p = 0.007), depression (r = 0.24, p = 0.007) and fear of COVID-19 (r = 0.27, p = 0.002) was found among high-risk pregnant women. CONCLUSION: Women with high-risk pregnancies experienced lower quality of life, higher anxiety and depression, and greater fear of COVID-19. There was also a weak relationship between social capital and the aforementioned variables among high-risk pregnant women. Designing and implementing interventions to increase quality of life and reduce anxiety and stress among high-risk pregnant women appears to be warranted.

Evaluation of the effects of conventional versus laser bleaching techniques on enamel microroughness.

Nowadays, bleaching of the teeth within the dental office is one of the most widespread techniques to correct tooth discoloration. Variability of the materials and techniques accompanied with the trend toward esthetic restorations with minimally invasive approaches are increasing. The use of laser in this regard has also been taken into consideration. The aim of this study was to evaluate the effects of in-office versus laser bleaching on surface roughness of enamel. Fifteen freshly extracted human molars were sectioned mesiodistally to produce 30 lingual and buccal enamel blocks. Samples were mounted in transparent acrylic resin blocks and polished before treatment. Samples were randomly assigned to laser bleaching (LB) and office bleaching (OB) groups (n = 15 each). Pretreatment evaluation of microroughness was carried out for all samples using profilometer. Samples were treated twice in the OB group with Opalescent Xtra Boost and in the LB group using a laser-activated gel. Microroughness was evaluated after bleaching in both groups. Data were analyzed using repeated measure ANOVA. Both methods increased enamel surface roughness. Microroughness changes were significantly different between the two groups (p < 0.05). Microroughness significantly increased in the OB group (p > 0.05), but there was no significant difference in pre- and post-treatment roughness evaluation in the LB group (p < 0.05). Laser was considered a safer technique because it demonstrated a less surface roughness increase in comparison with the conventional office bleaching procedure.