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INTRODUCTION: Placenta accreta spectrum is a major obstetric disorder that is associated with significant morbidity and mortality. The objective of this study is to establish a prediction model of clinical outcomes in these women. MATERIALS AND METHODS: PAS-ID is an international multicenter study that comprises 11 centers from 9 countries. Women who were diagnosed with PAS and were managed in the recruiting centers between 1 January 2010 and 31 December 2019 were included. Data were reanalyzed using machine learning (ML) models, and 2 models were created to predict outcomes using antepartum and perioperative features. ML model was conducted using python® programing language. The primary outcome was massive PAS-associated perioperative blood loss (intraoperative blood loss ≥2500 ml, triggering massive transfusion protocol, or complicated by disseminated intravascular coagulopathy). Other outcomes include prolonged hospitalization >7 days and admission to the intensive care unit (ICU). RESULTS: 727 women with PAS were included. The area under curve (AUC) for ML antepartum prediction model was 0.84, 0.81, and 0.82 for massive blood loss, prolonged hospitalization, and admission to ICU, respectively. Significant contributors to this model were parity, placental site, method of diagnosis, and antepartum hemoglobin. Combining baseline and perioperative variables, the ML model performed at 0.86, 0.90, and 0.86 for study outcomes, respectively. Ethnicity, pelvic invasion, and uterine incision were the most predictive factors in this model. DISCUSSION: ML models can be used to calculate the individualized risk of morbidity in women with PAS. Model-based risk assessment facilitates a priori delineation of management.
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Placenta Accreta , Femenino , Humanos , Embarazo , Placenta Accreta/cirugía , Placenta Accreta/diagnóstico , Placenta , Pérdida de Sangre Quirúrgica , Transfusión Sanguínea , Aprendizaje Automático , Estudios Retrospectivos , Histerectomía/métodosRESUMEN
PURPOSE: To evaluate the levonorgestrel-releasing intrauterine system Donasert® (also known as Levosert®) compared with the reference product Mirena® for the alleviation of heavy menstrual bleeding (HMB). MATERIALS AND METHODS: A phase 3 multicentre, non-inferiority, active-controlled study in non-menopausal women with HMB (menstrual blood loss [MBL] ≥ 80 mL) as the primary symptom randomised to either Donasert® or Mirena® and followed for 6 months. MBL was evaluated using a validated, modified version of the Wyatt pictogram. RESULTS: Overall, 312 were randomised (158 to Donasert® and 154 to Mirena®). The mean (standard deviation) absolute change in MBL from baseline to 6 months in the per-protocol population (N = 300) was -130 (71.8) mL and -127 (67.3) mL in the Donasert® and Mirena® groups, respectively; non-inferiority of Donasert® was confirmed (p-value <0.0001). Successful treatment of HMB (MBL <80 mL) and a decrease to ≤50% of baseline MBL was achieved in 139/154 (90.3%) and 126/146 (86.3%) participants in the Donasert® and Mirena® groups, respectively and the between-treatment difference was non-significant. Most adverse events were mild in severity. Only two device expulsions occurred in the study and there were no uterine perforations. CONCLUSIONS: Donasert® has equivalent efficacy and safety during the first 6 months foralleviation of HMB compared to the reference device, Mirena®. TRIAL REGISTRATION NUMBER: 348 (Clinical Trials Registry of the Ministry of Health of the Russian Federation, http://grls.rosminzdrav.ru/default.aspx).
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Dispositivos Intrauterinos Medicados , Menorragia , Femenino , Humanos , Levonorgestrel/efectos adversos , Menorragia/tratamiento farmacológicoRESUMEN
OBJECTIVE: To create a model for prediction of success of uterine-preserving procedures in women with placenta accreta spectrum (PAS). METHODS: PAS-ID is a multicenter study that included 11 centers from 9 countries. Women with PAS, who were managed between January 1, 2010 and December 31, 2019, were retrospectively included. Data were split into model development and validation cohorts, and a prediction model was created using logistic regression. Main outcome was success of uterine preservation. RESULTS: Out of 797 women with PAS, 587 were eligible. Uterus-preserving procedures were successful in 469 patients (79.9%). Number of previous cesarean sections (CS) was inversely associated with management success (adjusted odds ratio [aOR] 0.02, 95% confidence interval [CI] 0.001-3.63 with five previous CS). Other variables were complete placental invasion (aOR 0.14, 95% CI 0.05-0.43), type of CS incision (aOR 0.04, 95% CI 0.01-0.25 for classical incision), compression sutures (aOR 2.48, 95% CI 1.00-6.16), accreta type (aOR 3.76, 95% CI 1.13-12.53), incising away from placenta (aOR 5.09, 95% CI 1.52-16.97), and uterine resection (aOR 102.57, 95% CI 3.97-2652.74). CONCLUSION: The present study provides a prediction model for success of uterine preservation, which may assist preoperative and intraoperative decisions, and promote incorporation of uterine preservation procedures in comprehensive PAS protocols.
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Placenta Accreta/cirugía , Placenta/cirugía , Útero/cirugía , Adulto , Cesárea , Femenino , Humanos , Histerectomía , Embarazo , Estudios RetrospectivosRESUMEN
OBJECTIVE: The aim of the study was to test the hypothesis that in the human uterus, the effectiveness of P2 receptor-mediated contractile responses is up-regulated during pregnancy. STUDY DESIGN: Experiments were performed on myometrial samples obtained from women undergoing caesarean section at 28-30 weeks of pregnancy (3 women, Group 1), 32-34 weeks of pregnancy (6 women, Group 2) and 38-41 weeks of pregnancy (16 women, Group 3). Concentration-response relationships for a non-selective P2 receptor agonist, adenosine 5'-triphosphate (ATP), a selective P2X receptor agonist, alpha,beta-methylene-ATP (alpha,beta-meATP), and a frequency-response relationship for non-adrenergic non-cholinergic (NANC) electrical field stimulation (EFS) were obtained using routine pharmacological organ bath technique. Effects of pyridoxalphosphate azophenyl-2',4'-disulphonic acid (PPADS, 10(-5) M), a P2 receptor antagonist, were also evaluated. Parametric Student's t-test, non-parametric Wilcoxon T-test, Mann-Whitney U-test, two-way analysis of variance (ANOVA) and Krushkal-Wallis tests were used for statistical analysis. RESULTS: ATP (10(-6) to 3 x 10(-4) M), alpha,beta-meATP (10(-7) to 3 x 10(-5) M) and EFS (2-32 Hz) evoked contractions of isolated pregnant uterus in all three groups. Uterus responses to ATP were not correlated with the term of pregnancy while the amplitude of uterine contractions to alpha,beta-meATP and EFS was higher in full term pregnancy than in earlier pregnancy. PPADS antagonized uterus responses to alpha,beta-meATP and EFS, but not to ATP, in all three groups. CONCLUSION: P2X receptor-mediated contractions of human pregnant uterus to alpha,beta-meATP and EFS, but not to ATP, are increased with the progression of pregnancy.