To evaluate whether daily enoxaparin, added to low-dose aspirin, started before 14 weeks of gestation reduces placenta-mediated complications in pregnant women with previous severe preeclampsia ...diagnosed before 34 weeks of gestation.
In this open-label multicenter randomized trial, we enrolled consenting pregnant women with previous severe preeclampsia diagnosed before 34 weeks of gestation, gestational age at randomization of 7-13 weeks, singleton pregnancy, and no plan for anticoagulation. Eligible patients were randomly assigned to a one-to-one ratio to receive daily either 4,000 international units enoxaparin plus 100 mg aspirin or 100 mg aspirin alone. Randomization was done by a web-based randomization system. The primary composite outcome comprised maternal death, perinatal death, preeclampsia, small for gestational age (less than the 10th percentile), and placental abruption. A sample size of 232 women equally divided into two groups was needed to detect a significant reduction in primary outcome from 55% in the aspirin group to 36.7% in the enoxaparin-aspirin group (α: 0.05, β: 0.8, two-sided).
Between November 14, 2009, and February 21, 2015, 257 participants were enrolled. Baseline demographic and clinical factors were similar between groups. Eight women were excluded after randomization (six in the enoxaparin-aspirin group and two in the aspirin group), leaving 124 participants assigned to enoxaparin-aspirin and 125 to aspirin. Five participants were lost to follow-up (two in the enoxaparin-aspirin group and three in the aspirin group). There was no significant difference between the groups in the primary outcome: enoxaparin-aspirin 42 of 122 (34.4%) compared with aspirin alone 50 of 122 (41%) (relative risk 0.84, 95% confidence interval 0.61-1.16, P=.29). The occurrence of complications did not differ between the two groups.
Antepartum prophylactic enoxaparin does not significantly reduce placenta-mediated complications in women receiving low-dose aspirin for previous severe preeclampsia diagnosed before 34 weeks of gestation.
ClinicalTrials.gov, https://clinicaltrials.gov, NCT00986765.
To describe the course over time of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in French women from the beginning of the pandemic until mid-April, the risk profile of ...women with respiratory complications, and short-term pregnancy outcomes.
We collected a case series of pregnant women with COVID-19 in a research network of 33 French maternity units between March 1 and April 14, 2020. All cases of SARS-CoV-2 infection confirmed by a positive result on real-time reverse transcriptase polymerase chain reaction tests of a nasal sample and/or diagnosed by a computed tomography chest scan were included and analyzed. The primary outcome measures were COVID-19 requiring oxygen (oxygen therapy or noninvasive ventilation) and critical COVID-19 (requiring invasive mechanical ventilation or extracorporeal membrane oxygenation, ECMO). Demographic data, baseline comorbidities, and pregnancy outcomes were also collected.
Active cases of COVID-19 increased exponentially during March 1–31, 2020; the numbers fell during April 1–14, after lockdown was imposed on March 17. The shape of the curve of active critical COVID-19 mirrored that of all active cases. By April 14, among the 617 pregnant women with COVID-19, 93 women (15.1 %; 95 %CI 12.3–18.1) had required oxygen therapy and 35 others (5.7 %; 95 %CI 4.0–7.8) had had a critical form of COVID-19. The severity of the disease was associated with age older than 35 years and obesity, as well as preexisting diabetes, previous preeclampsia, and gestational hypertension or preeclampsia. One woman with critical COVID-19 died (0.2 %; 95 %CI 0−0.9). Among the women who gave birth, rates of preterm birth in women with non-severe, oxygen-requiring, and critical COVID-19 were 13/123 (10.6 %), 14/29 (48.3 %), and 23/29 (79.3 %) before 37 weeks and 3/123 (2.4 %), 4/29 (13.8 %), and 14/29 (48.3 %) before 32 weeks, respectively. One neonate (0.5 %; 95 %CI 0.01–2.9) in the critical group died from prematurity.
COVID-19 can be responsible for significant rates of severe acute, potentially deadly, respiratory distress syndromes. The most vulnerable pregnant women, those with comorbidities, may benefit particularly from prevention measures such as a lockdown.
•ERAS program was successfully implemented with a good compliance of ERAS parameters.•ERAS program was associated with a reduction in length of stay, but mostly with a large increase in outpatient ...care.•We measured a very high patient satisfaction (89%).
The primary objective of this study was to compare lengths of stay since ERAS program implementation. We also evaluated ERAS protocol compliance, compared the outpatient rate, the complication rate and the readmission rate within 30 days after surgery and performed a satisfaction study.
This is a monocentric comparative study with a historical control group, performed in the gynecological surgery department of the University Hospital of Saint-Etienne. We compared a group of patients who underwent surgery in 2016, before the implementation of ERAS program, with a group of patients who underwent surgery from July 2021 to July 2022, for whom ERAS program was applied.
187 patients were included in this study, including 84 patients in the historical group before ERAS and 103 in the group with ERAS. Considering all approaches, the average length of stay decreased by 2 days (p<0.0001). Considering minimally invasive surgery, the outpatient rate increased from 5% to 50% (p<0.0001) and complication rate decreased from 23 to 11% (p = 0,04). The readmissions rate was similar. Satisfaction score for patients managed with ERAS program was 8.9/10.
The implementation of ERAS program in gynecological oncology surgery allowed a reduction in length of stay, with a high outpatient rate, decreasing complications in case of minimally invasive surgery, without increasing the readmission rate, and was associated with good patient satisfaction.
The aim of this study was to evaluate the performance of indocyanine green (ICG) compared to that of the gold standard 99mtechnetium (99mTc-nanocolloids) in detecting sentinel lymph nodes (SLN) in ...early vulvar cancer.
A single-center retrospective cohort study comparing SLN detection by 99mTc-nanocolloids and ICG was performed in patients presenting early vulvar cancer (T1/2), with clinically negative nodes. All SLN showing a radioactive and/or fluorescent signal were resected. The primary endpoints were the sensitivity, positive predictive value (PPV) and false negative (FN) rate of ICG in detecting SLN compared to 99mTc-nanocolloids.
Thirty patients were included and 99 SLN were identified in 43 groins. Compared to 99mTc-nanocolloids, ICG had a sensitivity of 80.8% (95% CI 72.6; 88.6%), a PPV of 96.2% (95% CI 91.8; 100%) and a FN rate of 19.1% in detecting SLN. Seventeen (17.1%) infiltrated (positive) SLN were identified out of the 99 SLN detected. Compared to 99mTc-nanocolloids, ICG showed a sensitivity of 82.3% (95% CI 73.1; 91.5%), a PPV of 100% and a FN rate of 17.6% (3/17) in detecting infiltrated SLN.
Despite its many advantages, ICG cannot be used as the sole tracer for the detection of SLN in early vulvar cancer and should be employed in conjunction with 99mTc-nanocolloids.
Introduction
The recently proposed YEARS algorithm was shown to safely exclude pulmonary embolism (PE) and reduce the use of computed tomography pulmonary angiography (CTPA) among pregnant women with ...suspected PE. Our aim was to externally validate this finding.
Methods
We performed a post hoc analysis of a prospective management outcome study for PE diagnosis in pregnant women. PE was diagnosed with an algorithm that combined the revised Geneva score, D‐dimer testing, bilateral lower‐limb compression ultrasonography, and CTPA. All women had a 3‐month follow‐up. All of the items necessary to use the YEARS algorithm were prospectively collected at the time of the study.
Results
Of the 395 women included in the original study, 371 were available for the present analysis. The PE prevalence was 6.5%. Ninety‐one women had no YEARS items, and 280 had one or more items. When the YEARS items were combined with D‐dimer levels (<1000 ng/mL in women with no items, and <500 ng/mL in women with one or more items), 77 women (21%) met the criteria for PE exclusion and would not have undergone CTPA as per the YEARS algorithm. None of these 77 women had PE diagnosed during the initial work‐up or 3‐month follow‐up. Therefore, the failure rate of the YEARS algorithm in our pregnant women population was 0/77 (95% confidence interval 0.0‐3.9).
Conclusion
In our study, application of the YEARS algorithm would have resulted in safe exclusion of PE in one of five pregnant women without the need for radiation exposure, further supporting the use of the algorithm in this population.
Management of pregnant women at risk of venous thromboembolism (VTE) and placental vascular complications (PVCs) remains complex. Guidelines do not definitively specify optimal strategies.
Our ...objective was to evaluate the impact of employing risk score-driven prophylaxis strategies on VTE and PVC rates in at-risk pregnant women.
This study, conducted in 21 French maternity units, compared VTE and PVC rates before and after implementation of a risk scoring system to determine prophylactic strategies.
A total of 2,085 pregnant women at risk of VTE or PVC were enrolled. Vascular events occurred in 190 (19.2%) patients before and 140 (13.0%) after implementation of risk score-driven prophylaxis (relative risk RR = 0.68 0.55; 0.83). The incidence of deep vein thrombosis during pregnancy was reduced (RR = 0.30 0.14; 0.67). PVC comprised mainly pre-eclampsia, occurring in 79 patients before and 42 patients after risk score implementation (RR = 0.52 0.36; 0.75). Post-partum haemorrhage occurred in 32 patients (3.2%) before and 48 patients (4.5%) after risk score implementation (RR = 1.38 0.89; 2.13,
= 0.15).
Use of a simple risk scoring system, developed by experts in VTE and PVC research to guide prophylaxis, reduced the risk of thrombotic events during pregnancy without any significant increase in bleeding risk.
Uterine clear cell carcinomas (CCC) represent less than 5% of uterine cancers. Their biological characteristics and clinical management remain uncertain. A multicenter study to explore both clinical ...and molecular features of these rare tumors was conducted.
This multicenter retrospective national study was performed within the French TMRG (Rare Gynecologic Malignant Tumors) network. Clinical data and, when available, FFPE blocks were collected. Clinical features, treatments, and outcome (progression-free survival (PFS) and overall survival (OS)) were analyzed and correlated to the protein (tissue micro-array), RNA (Nanostring nCounter
technology), and DNA (array-Comparative Genomic hybridization and target-next generation sequencing) levels using the tumor samples available.
Sixty-eight patients with uterine CCC were enrolled, 61 from endometrial localization and 5 with cervix localization. Median age at diagnosis was 68.9 years old (range 19-89.7). Most tumors were diagnosed at an early stage (78% FIGO stage I-II). Hysterectomy (performed in 90%) and lymph node dissection (80%) were the most frequent surgical treatment. More than 70% of patients received external beam radiotherapy and 57% received brachytherapy. Nearly half (46%) of the patients received chemotherapy. After a median follow-up of 24.7 months, median PFS was 64.8 months (95 CI 5.3-124.4) and median OS was 79.7 (IC95 31.0-128.4). Low hormone receptor expression (13% estrogen-receptor positive), frequent PI3K pathway alterations (58% PTEN loss, 50% PIK3CA mutations), and P53 abnormalities (41%) were observed. Mismatch repair deficiency was identified in 20%. P16 expression was associated with shorter PFS (HR = 5.88, 95 CI 1.56-25, p = 0.009). Transcriptomic analyzes revealed a specific transcriptomic profile notably with a high expression of immune response-associated genes in uterine CCC displaying a very good overall prognosis.
Uterine CCC reported to be potentially MSI high, hormone receptors negative, and sometimes TP53 mutated. However, some patients with immune response-associated features and better prognosis may be candidate to treatment de-escalation and immunotherapy.
The incidence of venous thromboembolism (VTE) during pregnancy is about one event per 1000 pregnancies and placenta-mediated pregnancy complications (PC) occurred in 15%. Knowing the biological ...combined with clinical risk factors would help to prevent problems during the pregnancy. Several antithrombotic therapies exist, including very recent ones but LMWH and aspirin are still molecules of choice. The women should be assessed for VTE and PC risk in order to improve the outcome.
Background
The diagnosis of pulmonary embolism (PE) in pregnant women represents an ongoing challenge. As in the general population, the first step in pregnant women with suspected PE consists of ...assessing clinical pre‐test probability (PTP). However, no dedicated clinical decision rule has been developed in this population.
Objective
To propose a new version of the Geneva score adapted to pregnant women with suspected PE.
Methods
Data from a multicenter, prospective management outcome study including 395 women with suspected PE, in whom PTP was assessed using the Geneva score, were used. We first removed items which were present in none of the patients (cancer, age >65 years). Receiver operating characteristic (ROC) curve analysis was then performed for quantitative variables and the optimal threshold defined. The obtained Pregnancy‐Adapted Geneva Score (PAG Score) comprised seven items, including an age 40 years or older and a heart rate >110 beats per minute.
Results
The PAG Score showed a high discriminative power to identify patients with a low, intermediate, or high PTP, associated with increasing prevalence of PE, 2.3%, 11.6%, and 61.5%, respectively. The ROC curves showed an area under the curve of 0.795 for the PAG Score compared to 0.684 for the Geneva score.
Conclusion
In pregnant women with suspected PE, the PAG Score shows a high discriminative power to identify patients at low, intermediate, or high PTP. It has the strength of being a fully objective decision rule, is clinically relevant, easy to compute, and should now be tested in a prospective outcome study.
The main standard of care for locally advanced cervix carcinoma (LACC) is radiochemotherapy (RCT) followed by brachytherapy. A surgical approach may still be discussed based on pelvic MRI-derived ...residual tumour evaluation. As no interobserver agreement study has ever been conducted to our knowledge, the aim of the present study was to report on pelvic MRI accuracy and interobserver agreement in LACC.
We carried out a retrospective study in a French university hospital. Medical records of all consecutive patients treated with curative intent for LACC by RCT followed by brachytherapy and completion pelvic surgery between January 2014 and January 2020 were reviewed. Local response was assessed through pelvis MRI and histological analysis after completion surgery. MRI data were independently evaluated by two radiologists with varying experience. The two main interobserving criteria we used were complete response and residual tumour.
23 patients fulfilled the inclusion criteria. Agreement between the junior and senior radiologist was moderate to strong. Indeed, regarding main criteria, κ was 0.65 for complete response and 0.57 for residual tumour. Interestingly, the present study shows a lower sensitivity whatever the radiologists than in the international literature.
The present study highlights a low interobserver variability regarding pelvic MRI in the assessment of RCT followed by brachytherapy in LACC. Yet, sensitivity was lower than in literature.
Radiology is part of treatment decision-making, the issue of heterogeneity regarding radiologists' training and experience to cancer (sensitivity and specificity) turns essential, so does MRI accuracy.
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