Background: Maternal levels of angiogenic factors are promising prognostic parameters in patients with suspected preeclampsia, but in women with confirmed preeclampsia this performance has been less explored. Objective: To assess in women with early-onset severe preeclampsia whether longitudinal changes in angiogenic factors improve the prediction of adverse outcome. Study design: A cohort was created of consecutive women admitted for early-onset severe preeclampsia with no indication for immediate delivery. Levels of placental growth factor [PlGF], soluble fms-like tyrosine kinase [sFlt-1] and sFlt-1/PlGF ratio were measured at admission and before delivery; and average daily change was calculated. The association of longitudinal changes of angiogenic factors with maternal complications and with the time interval to delivery was evaluated by logistic and Cox regression. Results: Sixty-three women were analyzed, of which 23 (36.5%) had a complication. Longitudinal changes of sFlt-1 were more pronounce in complicated pregnancies (median: 1079.5 vs. 343.7 pg/mL/day; p=0.04). On the multivariate analysis, the baseline model (clinical risk score and sFlt-1 at admission) explained a 6.6% of the uncertainty for complication (R2-Naegelkerke). The addition of sFlt-1 longitudinal changes improved this performance to 23.2% (p=0.004). The median time from admission to delivery was 3 days (95% confidence interval: 1.9-4.05) in those in the highest quartile of sFlt-1 longitudinal changes vs. 10 days (95% confidence interval: 8.1-11.9) in the remaining women (Log-rank test p<0.001). Conclusions: Longitudinal changes in sFlt-1 maternal levels from admission for confirmed early-onset severe preeclampsia add to baseline characteristics in the prediction of maternal complications.
Objective To compare the safety and efficacy of Veregen® ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN). Design A Phase II randomised control trial. Setting A tertiary gynaecological oncology referral center. Population All women diagnosed with primary and recurrence uVIN. Methods Eligible patients were randomised to receive either Veregen® or placebo ointment (applied 3 times daily for 16 weeks), and were followed up at 2, 4, 8, 16, 32 and 52 weeks. Main outcome measures Outcome measures, recorded at 16 and 32 weeks, were histological (HR) and clinical (CR) response (as measured by ≥30% reduction in the sum of the longest diameter of all lesions when compared to baseline), toxicity and changes in quality of life and pain scores. Results 26 patients were randomised and all 13 patients who received Veregen® showed either complete (n=5) or partial (n=8) CR with a trend towards an improvement in baseline symptoms. In placebo group, 3 patients had complete CR, 2 had partial CR and 6 had stable disease. Patients in the Veregen® group showed a significant improvement in CR as compared to the placebo group (P=0.0026). There was no evidence of difference in HR and toxicity reported in both groups. Conclusion Our study indicates that Veregen application is safe and leads to at least a partial clinical resolution of uVIN lesions and symptoms improvement, thus warranting a phase III multi-centre RCT.
Background: Postpartum haemorrhage (PPH) rates are increasing in developed countries. A reliable prognostic tool for PPH has potential to aid prevention efforts. Objective: To systematically identify and appraise prognostic modelling studies for prediction of PPH. Search strategy: MEDLINE, Embase, CINAHL and the Cochrane Library were searched using a combination of terms and synonyms including ‘prediction tool’, ‘risk score’ and ‘postpartum haemorrhage’. Selection criteria: Any observational or experimental study developing a prognostic model for women’s risk of PPH. English language publications. Data collection and analysis: Predesigned data extraction form to record: data source; participant criteria; outcome; candidate predictors; actual predictors; sample size; missing data; model development; model performance; model evaluation; interpretation. Main Results: Of 1723 citations screened, 10 studies were eligible for inclusion. An additional paper was published and identified following completion of the search. Studies addressed populations of women who experienced; placenta praevia; vaginal births; caesarean birth; and the general obstetric population. Primary study authors deemed four models to be confirmatory. There was a high risk of bias across all studies due to a combination of retrospective selection of women, low sample size, no internal validation, suboptimal external validation and no reporting of missing data. Conclusion: Of eleven prognostic models for PPH risk, one developed for women undergoing caesarean section is deemed suitable for external validation. Future research requires robust internal and external validation of existing tools and development of a model that can be used to predict PPH in the general obstetric population. Protocol registration number: PROSPERO 95587
Despite extensive research, the pathophysiology and prevention of pre-eclampsia remain elusive, diagnosis is challenging, and pre-eclampsia remains associated with adverse maternal and perinatal outcomes. Angiogenic biomarkers, including placental growth factor (PlGF) and soluble fms-like tyrosine kinase 1 (sFlt-1), have been identified as valuable biomarkers for preterm pre-eclampsia, accelerating diagnosis and reducing maternal adverse outcomes by risk stratification, with enhanced surveillance for high-risk women. PlGF-based testing is increasingly being implemented into clinical practice in several countries. This review provides healthcare providers with an understanding of the evidence for PlGF-based testing and describes the practicalities and challenges to implementation.
Abstract Objective To evaluate the clinical diagnostic validity of carbon nanoparticle suspension (CNS) in sentinel lymph node biopsy (SLNB) for assessing lymphatic spread of early-stage cervical cancer. Design A prospective study. Setting and population 356 cases. Methods We enrolled 356 stage Ia2-IIa2 cervical cancer patients to undergo SLNB using CNS followed by systematic pelvic lymphadenectomy. All lymph node specimens were assessed using conventional histopathologic ± pathologic ultrastaging analyses. Main outcome measures SLN detection rate (DR), clinical diagnostic validity, and various related factors were analysed. Results CNS identified 1456 SLNs in 325 patients. The overall SLN DR was 91.29%. A significantly higher DR was found for patients with tumours <20 mm (97.75% vs. 71.91%; p = 0.000). Two patients had false-negative results, accounting for 0.615% of patients who had successful SLN detection. SLNB with CNS had sensitivity of 92.86%, false-negative rate (FNR) of 7.14%, and negative predictive value (NPV) of 99.29%. Importantly, sensitivity (100%), NPV (100%), and FNR (0%) were improved when testing the subgroup of patients with tumours <20 mm (267 cases). There were no observed differences in DR based on pathologic type or grade, stage, depth of stromal invasion, surgical approach, menopausal status, or prior treatment with chemotherapy (p > 0.05). Conclusions SLNB with CNS results in favourable DR, sensitivity, and NPV for women with early-stage cervical cancer with small tumour sizes. SLNB with CNS is safe, feasible, and relatively effective for guiding precise surgical treatment of early-stage cervical cancer. Keywords SLNB, CNS, early-stage cervical cancer
Objective: To evaluate the effectiveness of virtual reality as a distraction technique in the management of acute pain and anxiety during outpatient hysteroscopy. Methods: A parallel group, prospective randomised controlled trial was conducted at a UK University Hospital (August to October 2018) (ClinicalTrials.gov Id: NCT03699280). Forty consenting, eligible women were randomised to virtual reality intervention (immersive video content as a distraction method) or standard care during outpatient hysteroscopy. Pain and anxiety outcomes were measured as a numeric rating score (scale of 0-10). Results: Compared to standard care, women with virtual reality intervention experienced less average pain (score 6.0 vs 3.7, mean difference 2.3, 95% CI 0.61-3.99, p=0.009) and anxiety (score 5.45 vs 3.3, mean difference 2.15, 95% CI 0.38-3.92, p=0.02). Conclusion: Virtual Reality was effective in reducing pain and anxiety during outpatient hysteroscopy in a pilot trial. Its wide potential role in ambulatory gynaecologic procedures needs further evaluation.
Objective: To determine whether planned cesarean section (CS) for a second delivery protects anal continence in women with obstetrical anal sphincter lesions. Design: Randomized trial. Setting: 6 maternity units in the Paris area. Sample : Women at high risk of sphincter lesions (first delivery with 3d degree laceration and/or forceps) but no symptomatic anal incontinence. Methods : Endoanal ultrasound was performed in the third trimester of the second pregnancy. Women with sphincter lesions were randomized to planned CS or vaginal delivery (VD). Main outcome measures : Anal continence at 6 months post-partum. Secondary outcomes were urinary continence, sexual morbidity, maternal and neonatal morbidities and worsening of external sphincter lesions. Results : Anal sphincter lesions were detected by ultrasound in 264/434 women enrolled (60.8%) ; 112 were randomized to planned VD and 110 to planned CS. At 6-8 weeks after delivery, there was no significant difference in anal continence between the 2 groups. At 6 months after delivery, median Vaizey scores of anal continence were 1 [IQR 0-4] in the CS group and 1 [IQR 0-3] in the VD group (p = 0.34). There were no significant differences for urinary continence, sexual functions or for other maternal and neonatal morbidities. Conclusions : In women with asymptomatic obstetrical anal sphincter lesions diagnosed by ultrasound, planning a CS had no significant impact on anal continence 6 months after the second delivery. These results do not support advising systematic CS for this indication.
Since December 2019, a new coronavirus (COVID-19) infection has rapidly become prevalent in central China . On the basis of knowledge obtained from a previous coronavirus outbreak , pregnant women are believed to be susceptible to this virus. Once a maternal infection of 2019-nCoV is suspected or confirmed, childbirth becomes complicated and challenging. Efficient obstetric treatment is required, and is key to optimizing the prognosis for both mother and child. Care should be taken in determination of the timing of delivery, assessment of the indications for caesarean section, preparation of the delivery room to prevent infection, choice of the type of anesthesia, and newborn management.