6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial.

BACKGROUND: Vasopressor administration is recommended to prevent hypotension during spinal anaesthesia (SA) for elective Caesarean delivery. We aimed to test the superior efficacy and ensure safety of a hydroxyethyl starch (HES) vs a Ringer's lactate (RL) preloading, when combined with a phenylephrine-based prophylaxis. METHODS: A total of 167 healthy parturients undergoing elective Caesarean delivery under SA were included in this multicentre, randomized, double-blind study. Patients received 500 ml of 6% HES (130/0.4)+500 ml of RL (HES group) or 1000 ml of RL (RL group) i.v. before SA. After SA, i.v. phenylephrine boluses were titrated when systolic arterial pressure (SAP) was below 95% of baseline. The primary outcome was the incidence of maternal hypotension (SAP <80% of baseline). RESULTS: The incidence of both hypotension and symptomatic hypotension (i.e. with dizziness, nausea/vomiting, or both) was significantly lower in the HES group vs the RL group: 36.6% vs 55.3% (one-sided P=0.025) and 3.7% vs 14.1%. There was no significant difference in total phenylephrine requirements [median (range): 350 (50-1800) vs 350 (50-1250) µg]. The decrease in maternal haemoglobin value the day after surgery was similar in the two groups [1.2 (1.0) vs 1.0 (0.9) g dl(-1)]. There was no detectable placental transfer of HES in six umbilical cord blood samples analysed in the HES group. Neonatal outcomes were comparable between the groups. CONCLUSIONS: Compared with a pure RL preloading, a mixed HES-RL preloading significantly improved prevention of both hypotension and symptomatic hypotension based on early phenylephrine bolus administration and did not induce adverse effects. CLINICAL TRIAL REGISTRATION: NCT00694343 (http://clinicaltrials.gov).

Binational confidential enquiry of maternal deaths due to postpartum hemorrhage in France and the Netherlands: Lessons learned through the perspective of a different context of care.

OBJECTIVE: To learn lessons for maternity care by scrutinizing postpartum hemorrhage management (PPH) in cases of PPH-related maternal deaths in France and the Netherlands. METHODS: In this binational Confidential Enquiry into Maternal Deaths (CEMD), 14 PPH-related maternal deaths were reviewed by six experts from the French and Dutch national maternal death review committees regarding cause and preventability of death, clinical care and healthcare organization. Improvable care factors and lessons learned were identified. CEMD practices and PPH guidelines in France and the Netherlands were compared in the process. RESULTS: For France, new insights were primarily related to organization of healthcare, with lessons learned focusing on medical leadership and implementation of (surgical) checklists. For the Netherlands, insights were mainly related to clinical care, emphasizing hemostatic surgery earlier in the course of PPH and reducing the third stage of labor by prompter manual removal of the placenta. Experts recommended extending PPH guidelines with specific guidance for women refusing blood products and systematic evaluation of risk factors. The quality of CEMD was presumed to benefit from enhanced case finding, also through non-obstetric sources, and electronic reporting of maternal deaths to reduce the administrative burden. CONCLUSION: A binational CEMD revealed opportunities for improvement of care beyond lessons learned at the national level.

[Reprint of: Severe pre-eclampsia: guidelines for clinical practice from the French Society of anesthesiology and intensive care (SFAR) and the French College of gynaecologists and obstetricians (CNGOF)]. / Republication de : recommandations formalisées d'experts. Prise en charge de la patiente avec une pré-éclampsie sévère­RFE communes Société française d'anesthésie-réanimation (SFAR)­Collège national des gynécologues et obstétriciens français (CGNOF).

OBJECTIVE: To provide national guidelines for the management of women with severe preeclampsia. DESIGN: A consensus committee of 26 experts was formed. A formal conflict of interest (COI) policy was developed at the onset of the process and enforced throughout. The entire guidelines process was conducted independently of any industrial funding. The authors were advised to follow the principles of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. METHODS: The last SFAR and CNGOF guidelines on the management of women with severe preeclampsia was published in 2009. The literature is now sufficient for an update. The aim of this expert panel guidelines is to evaluate the impact of different aspects of the management of women with severe preeclampsia on maternal and neonatal morbidities separately. The experts studied questions within 7 domains. Each question was formulated according to the PICO (Patients Intervention Comparison Outcome) model and the evidence profiles were produced. An extensive literature review and recommendations were carried out and analyzed according to the GRADE® methodology. RESULTS: The SFAR/CNGOF experts panel provided 25 recommendations: 8 have a high level of evidence (GRADE 1±), 9 have a moderate level of evidence (GRADE 2±), and for 7 recommendations, the GRADE method could not be applied, resulting in expert opinions. No recommendation was provided for 3 questions. After one scoring round, strong agreement was reached between the experts for all the recommendations. CONCLUSIONS: There was strong agreement among experts who made 25 recommendations to improve practices for the management of women with severe preeclampsia.

[Maternal deaths due to hypertensive disorders in France 2013-2015]. / Morts maternelles par complications hypertensives en France 2013­2015.

Between 2013 and 2015, six maternal deaths were due to hypertensive disorders. During this period, the maternal mortality ratio was 0.2/100,000 live births. Hypertensive disorders were responsible for 2% of maternal deaths in France and for 5% of direct maternal mortality. All these deaths happened after the delivery. Mode of delivery was a cesarean section when the hypertensive complication started before the delivery (4/6; 67%). Three had DIC during the immediate post-partum. Five women were under 35 years old. Only one had a BMI over 30. Four out of six patients were primiparous. One woman was Afro-Caribbean. Medical care was estimated non-optimal in 100% of the cases. In three cases, it was prenatal care and in three cases it was obstetrical care during delivery; anesthesia and intensive care were suboptimal in five cases. Eighty percent of these deaths seemed to be preventable. The main causes of suboptimal management were inappropriate or insufficient obstetrical and/or anesthetic treatments, and delayed optimal treatment. The analysis of these maternal deaths offers the opportunity to stress major points to optimize medical management in case of hypertensive disorders during pregnancy such as management of eclampsia (use of magnesium sulfate) or recognition of DIC when HELLP syndrome is diagnosed.

[Maternal deaths due to infections in France 2013-2015]. / Mortalité maternelle par infection en France 2013­2015.

Over the 2013-2015 period, maternal mortality due to infections accounted for 10 % of direct maternal deaths and 13 % of indirect maternal deaths. Among the 21 deaths from infection, and compared to the last triennium, maternal deaths from genital infection doubled with 11 deaths during the 2013-2015 period. This included 6 cases of puerperal toxic shock syndrome, 4 of which due to Streptococcus A, and 5 cases of sepsis caused by intrauterine infection due to Gram-Negative Bacillus. Indirect maternal deaths due to infections from extragenital sources represented 10 deaths in this triennium, including four influenza infections and three infectious complications of an immunosuppressive state (uncontrolled HIV infection for two patients and CMV encephalitis during an immunosuppressive treatment for one patient). Of these 21 deaths by infectious causes, 6 direct maternal deaths and 9 indirect maternal deaths were considered preventable. The most common preventable factors were those related to medical management (13 times): diagnostic failure or delayed diagnosis leading to a delayed medical treatment, absence of influenza vaccination. The other contributory factors were related to the organization of healthcare (delayed transfer, lack of communication between clincians) as well as factors related to patient social vulnerability.

[Maternal mortality due to venous thromboembolism in France 2013-2015]. / Mortalité maternelle par thromboembolie veineuse en France 2013­2015.

Pregnancy and postpartum represent periods at very high risk of venous thromboembolism disease which appears to extend well beyond the classic 6-8 weeks after childbirth. Pulmonary embolism (PE) is still one of the three leading causes of direct maternal death (MM) in most developed countries. Between 2013 and 2015, 23 maternal deaths were caused by a venous thromboembolic complication (VTE) (20 pulmonary embolism and 3 cerebral thrombophlebitis), representing 8.8 % of maternal deaths and a Maternal Mortality Ratio of 1.0 per 100,000 live births (95 % CI 0.6-1, 4) which is stable over the last 10 years. Regarding the timing of death, 1 death occurred after abortion, 35 % (8/23) during an ongoing pregnancy (including four before 22 WG), and 61 % (14/23) after childbirth. Among the 23 deaths from VTE, 17 % (5/23) occurred outside a healthcare center (home, street). The mean age was 32.3 and 7 women (30 %) were≥35 years old. Six patients were obese (27 %). The preventability rate is 34.8 % (compared to 50 % in 2007-2009 and 2010-2012), The preventability factors involve the inadequacy of care in 34.8 % of cases (8/23), organizational factors in one case (1/23) and a lack of interaction of the patient with the health care system in two cases (2/23). Care was considered non-optimal in 59 % of these deaths. This proportion is higher than the preventability rate because suboptimal care sometimes did not influence the final outcome.

[Feticide procedures in second and third trimesters terminations of pregnancy]. / Geste d'arrêt de vie fœtale : techniques pour les interruptions médicales de grossesse des deuxième et troisième trimestres.

Performing a feticide as part of termination of late pregnancy is recommended in many countries. Feticide avoids a live birth of a severely affected premature newborn and prevents fetal pain. There are limited data on feticide procedures since only a few countries in the world authorize late termination of pregnancy. The objective of this review was to assess the most appropriate feticide procedure based on published data during the last thirty years. Administration of an initial fetal analgesia followed by a lethal lidocaine injection through the umbilical cord, under ultrasound guidance, appears to be the most effective, safe and ethical way to perform feticide. According to the current knowledge regarding the risk of fetal pain and survival of extremely preterm infants, a feticide should be discussed as early as 20-22 weeks of gestation.

Repeated attacks of type III hereditary angioedema with factor XII mutation during pregnancy.

In type III hereditary angioedema (HAE type III), the phenotype is the same as type I and type II disease, but the level and function of C1-esterase inhibitor (C1-INH) is normal. Hereditary angioedema type III has been described as an oestrogen-sensitive form because it can be triggered or aggravated by exposure to high oestrogen levels as seen during pregnancy, especially when associated with Factor XII mutation. This case report describes the evolution and management of repeated angioedema attacks during pregnancy in a woman with HAE, with normal levels and function of C1-INH (type III); and a mis-sense mutation of factor XII. The physiopathology and genetic features, the unpredictability of clinical manifestations and the management during pregnancy and delivery are discussed.

[Maternal deaths due to infectious cause, results from the French confidential enquiry into maternal deaths, 2010-2012]. / Mortalité maternelle par infection, résultats de l'ENCMM, France 2010­2012.

Over the period 2010-2012, maternal mortality from infectious causes accounted for 5% of maternal deaths by direct causes and 16% of maternal deaths by indirect causes. Among the 22 deaths caused by infection occurred during this period, 6 deaths were attributed to direct causes from genital tract origin, confirming thus the decrease in direct maternal deaths by infection during the last ten years. On the contrary, indirect maternal deaths by infection, from extragenital origin, doubled during the same period, with 16 deaths in the last triennium, dominated by winter respiratory infections, particularly influenza: the 2009-2010 influenza A (H1N1) virus pandemic was the leading cause of indirect maternal mortality by infection during the studied period. The main infectious agents involved in maternal deaths from direct causes were Streptococcus A, Escherichia Coli and Clostridium perfringens: these bacterias were responsible for toxic shock syndrome, severe sepsis, secondary in some cases to cellulitis or necrotizing fasciitis. Of the 6 deaths due to direct infection, 4 were considered avoidable because of inadequate management: delayed or missed diagnosis, delayed or inadequate initiation of a specific medical and/or surgical treatment. Of the 16 indirect maternal deaths due to infection causes, the most often involved infectious agents were influenza A (H1N1) virus and Streptococcus pneumonia with induced purpura fulminans: the absence of influenza vaccination during pregnancy, delayed diagnosis and emergency initiation of a specific treatment, were the main contributory factors to these deaths and their avoidability in 70% of the cases analyzed.

Low pressure gynecological laparoscopy (7mmHg) with AirSeal® System versus a standard insufflation (15mmHg): A pilot study in 60 patients.

OBJECTIVES: To evaluate feasibility of performing benign gynecologic pathology low pressure (7mmHg) laparoscopy (LPL) with AirSeal® system and to study benefits in terms of postoperative pain, when compared to a standard insufflation group (15mmHg). MATERIALS AND METHODS: In this prospective randomized pilot study, 60 patients had laparoscopy for gynecologic benign pathology: 30 with 7mmHg and AirSeal system, and 30 with 15mmHg standard insufflator. The primary endpoint was incidence of shoulder pain. A postoperative questionnaire was completed by each patient to assess shoulder pain (Numeric Rating Scale [NRS], from 0 to 10) at H4, H8, H24, and consumption of morphinics was notified. During each procedure, anesthesia parameters were collected (peak airway pressure, systolic blood pressure, end tidal CO2). RESULTS: Laparoscopy was performed on 30 patients in AirSeal®-LP group without need to increase pressure above 7mmHg, and no complication was reported. Incidence of shoulder pain was significantly lower in the AirSeal®-LP group (23.3% vs. 73.3%, P<0.001). NRS shoulder pain was significantly lower in AirSeal® LP group at hour 4, 8 and 24. Maximal values of ETCO2, systolic blood pressure, and peak airway pressure were significantly lower in AirSeal®-LP group. CONCLUSION: LP (7mmHg) laparoscopy with AirSeal® platform allows laparoscopic surgery with less postoperative shoulder pain. These results could facilitate the development of ambulatory laparoscopy.

[Preliminary results from the French study on prenatal repair for fetal myelomeningoceles (the PRIUM study)]. / Résultats préliminaires de l'étude PRIUM : programme de réparation in utero des myéloméningocèles.

OBJECTIVES: To present the preliminary results of the PRIUM study, a French pilot study of prenatal repair for myelomeningoceles (MMC). MATERIAL AND METHODS: The fetal surgery for MMC is offered in cases of patients that did not opt for termination of pregnancy. RESULTS: Thirty-six patients were referred in an 18-month period. Eight patients were not eligible for prenatal repair. Another type of dysraphism was made in 6 cases (one spina-lipoma, 5 cases of limited dorsal myeloschisis). Twenty-two patients were eligible to fetal surgery. A prenatal repair was performed in three cases (14%). Four patients opted for a conventional postnatal treatment. Fifteen patients opted for termination of the pregnancy. CONCLUSION: The establishment of a prenatal repair of MMC protocol in France was justified. The experience of the first 18months of this study however suggests that only a limited number of couples will choose this procedure after specialized counseling in a reference center.

[Prophylaxis of thromboembolic complications in obstetrics and gynaecology]. / Maladie thromboembolique périopératoire et obstétricale. Pathologie gynécologique et obstétricale.

Venous thromboembolism is a leading cause of maternal mortality in many countries, including France. Most enquiries have repeatedly demonstrated that many deaths could be avoided, suggesting the need to update and ensure a wider diffusion of recommendations. Although thromboembolism-induced maternal death plays a major role, the absolute incidence of events remains low, reducing the ability to perform well-designed research and the level of recommendations presented. Many personal or pregnancy-related factors have been identified as increasing the risk of thromboembolism in pregnant patients but few of them have been associated with a significantly increased risk. A history of thromboembolic event and some thrombophilic factors (including antithrombin deficiency and antiphospholipid syndrome) carry the greatest risk. Pregnancy itself, caesarean delivery and the postpartum period, although associated with an increased risk play a minor role when not combined with other risk factors. Prophylactic treatment relies mainly on low molecular weight heparins which safety is now well established in pregnant patients. Dose and duration of treatment should be adapted to the perceived level of risk. The occurrence of a thromboembolic event is also increased after gynaecological surgery but major and cancer surgery carry the greatest risk. Here also, low molecular weight heparins play a leading role, although non pharmacologic means are useful. Dose and duration should be dependent on the level of risk.

Pregnancy is associated with a decrease in pharyngeal but not tracheal or laryngeal cross-sectional area: a pilot study using the acoustic reflection method.

BACKGROUND: The risk of difficult upper airway access is increased during pregnancy, especially in labor. Changes in upper airway calibre have been poorly studied during pregnancy. The acoustic reflection method is a non-invasive technique that allows a longitudinal assessment of the cross-sectional area of the upper airway from the mouth to carina. We used this technique to evaluate upper airway calibre during normal pregnancy. METHODS: We conducted a prospective, single centre, observational study with a clinical and upper airway acoustic reflection method evaluation of healthy women during the first, second and third trimesters of pregnancy, and up to two days and one month after delivery. RESULTS: Fifty women participated to the study. The mean pharyngeal cross-sectional area decreased between the first and third trimesters (P < 0.001) with no significant change of the minimal and mean tracheal cross-sectional areas. The Mallampati score increased during pregnancy between the first and third trimesters (P< 0.001). CONCLUSION: Using measurements with the acoustic reflection method, normal pregnancy is associated with a significant reduction in the cross-sectional area of the pharynx and a concomitant increase in the Mallampati score. No change was observed in the minimal and mean tracheal cross-sectional areas.

[Update on propofol TCI in children]. / Nouvelles avancées en AIVOC pédiatrique au propofol.

For several years, total intravenous anaesthesia (TIVA) has demonstrated many advantages that allow considering propofol anaesthesia as an interesting alternative in pediatric anaesthesia. TCI in children requires calculation and validation of pharmacokinetic (PK) models specifically adapted to the paediatric population. Several PK models based on a 3-compartement approach have been proposed in children: all these models, which integrate only weight as covariable, show increased distribution volumes with a wide interindividual variability. The particular importance to include physiological covariables, as age and lean body mass, to describe metabolic processes during growth and maturation in pediatric PKPD models is in agreement with recent allometric scaling works in children. However, as pharmacodynamic (PD) parameters are still debated in children, there is up to now, no PKPD model currently available for paediatric anaesthesia. Schnider et al.'s model, a model described in adults that includes numerous covariables, may be adapted and more efficient than the classical paediatric models to describe propofol-PKPD relationship in children over 5years. Whatever the model, a pharmacodynamic feedback such as the bispectral index may be useful to counteract interindividual variability in the paediatric population.

[Gestational diabetes insipidus during a twin pregnancy]. / Diabète insipide gestationnel au cours d'une grossesse gémellaire.

Gestational diabetes insipidus is an uncommon clinical disease whose prevalence is approximately two to three pregnancies per 100,000. It may be isolated or associated with preeclampsia. We report a case of gestational diabetes insipidus in a twin pregnancy, originally isolated during two months, and secondarily complicated by HELLP-syndrome. We recall the specific pathophysiology of polyuric-polydipsic syndrome during pregnancy and summarize its various causes. Finally, we discuss the indications, in case of isolated gestational diabetes insipidus, of treatment by dDAVP.