Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial.

OBJECTIVE: To assess the benefits and safety of early human fibrinogen concentrate in postpartum haemorrhage (PPH) management. DESIGN: Multicentre, double-blind, randomised placebo-controlled trial. SETTING: 30 French hospitals. POPULATION: Patients with persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins. METHODS: Within 30 minutes after introduction of prostaglandins, patients received either 3 g fibrinogen concentrate or placebo. MAIN OUTCOME MEASURES: Failure as composite primary efficacy endpoint: at least 4 g/dl of haemoglobin decrease and/or transfusion of at least two units of packed red blood cells within 48 hours following investigational medicinal product administration. Secondary endpoints: PPH evolution, need for haemostatic procedures and maternal morbidity-mortality within 6 ± 2 weeks after delivery. RESULTS: 437 patients were included: 224 received FC and 213 placebo. At inclusion, blood loss (877 ± 346 ml) and plasma fibrinogen (4.1 ± 0.9 g/l) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the fibrinogen and placebo groups, respectively (odds ratio [OR] = 0.99) after adjustment for centre and baseline plasma fibrinogen; (95% CI 0.66-1.47; P = 0.96). No significant differences in secondary efficacy outcomes were observed. The mean plasma FG was unchanged in the Fibrinogen group and decreased by 0.56 g/l in the placebo group. No thromboembolic or other relevant adverse effects were reported in the Fibrinogen group versus two in the placebo group. CONCLUSIONS: As previous placebo-controlled studies findings, early and systematic administration of 3 g fibrinogen concentrate did not reduce blood loss, transfusion needs or postpartum anaemia, but did prevent plasma fibrinogen decrease without any subsequent thromboembolic events. TWEETABLE ABSTRACT: Early systematic blind 3 g fibrinogen infusion in PPH did not reduce anaemia or transfusion rate, reduced hypofibrinogenaemia and was safe.

[Breech Presentation: CNGOF Guidelines for Clinical Practice - Labour and Induction]. / Présentation du siège. Recommandations pour la pratique clinique du CNGOF ­ Accouchement.

OBJECTIVES: To issue guidelines on management of labour induction and breech vaginal delivery. MATERIALS AND METHODS: Bibliographic search restricted to French and English languages using Medline database®, Cochrane Library and international guidelines of medical societies. RESULTS: Breech delivery must take place in a maternity ward, in the presence of an obstetrician and gynaecologist and with the immediate availability of an anesthesiologist and a pediatrician during active second stage (Professional consensus). Term breech is not a contraindication to labour induction when the criteria for acceptance of vaginal delivery are met (Grade C). In this case, oxytocin or prostaglandins can be used (Grade C). Epidural analgesia with low concentrations of local anesthetics should be encouraged in case of vaginal delivery attempt (Professional consensus). It is recommended to use continuous monitoring of the CTG (Professional consensus). The use of second-line fetal monitoring is not recommended (Professional consensus). The administration of oxytocin is possible for labour augmentation (Professional consensus). It is better to start the expulsive efforts when the presentation is engaged as low as possible in the pelvic excavation (Professional consensus). Breech presentation is not an indication of episiotomy (Professional consensus). Due to insufficient data, it was not possible to make recommendations on specificities of preterm breech delivery. CONCLUSION: In case of planned vaginal delivery, labour induction is possible for term breech fetuses, even with unfarable cervix. Guidelines for labour and vaginal delivery management have a low level of evidence.

[Paraplegia and pregnancy]. / Paraplégie et grossesse : à propos d'une série rétrospective continue sur 11 années au CHU de Toulouse.

OBJECTIVES: To describe the characteristics of the management of pregnancy and child birth in women with spinal cord injury. MATERIALS AND METHODS: Retrospective cohort study including paraplegics patients with motor deficit (whatever the etiology) who gave birth at the University Hospital of Toulouse between March 2003 and March 2014 (11 years). Monitoring and outcome of pregnancy were studied. RESULTS: Seventeen deliveries (15 patients) were performed on a total of 46,888 in the studied period (prevalence=0.4‰). All patients had urinary tract infections: lower urinary tract (100%), recurrent cystitis (75%), pyelonephritis (31.3%). One patient (6.3%) presented dysautonomia during pregnancy. The cesarean rate was 47% (the indication was in any case an obstetrical reason). Among vaginal deliveries, four (44%) required an instrumental extraction. Epidural analgesia was the method of choice in the absence of contraindication. CONCLUSION: Pregnancy associated with spinal cord injury requires a multidisciplinary approach. Autonomic hyperreflexia syndrome must be known and can be avoided by epidural analgesia in early labor. Vaginal delivery should be the rule.

[Obstetric and anesthetic specificities in the management of a postpartum hemorrhage (PPH) associated with cesarean section]. / Spécificités obstétricales et anesthésiques de la prise en charge d'une hémorragie du post-partum (HPP) associée à la césarienne.

OBJECTIVES: To describe the characteristics of post-partum hemorrhage (PPH) associated with cesarean section (CS), the modalities diagnosis and specific obstetric and anesthetic management. MATERIALS AND METHODS: Bibliographic search restricted to French and English languages using Medline database(®) and international guidelines of medical societies. RESULTS: Primary PPH associated with CS (incidence 3-15%) is defined as vaginal bleeding ≥500mL within 24hours after surgery. Severe PPH is defined by bleeding ≥1000mL (professional consensus). The intervention threshold to initiate an active management depends on the flow rate of bleeding, the etiology and the clinical context. It can be higher than 500mL after cesarean (professional consensus). The main risk factor for bleeding is the realization of an emergency CS during labor (EL 3). In the case of persistent or severe intraoperative PPH due to uterine atony, conservative surgical procedures should be initiated in association with maternal resuscitation and second-line uterotonic therapy (sulprostone) (professional consensus). If general anesthesia is required, it is recommended to opt for a maintenance treatment limiting sevoflurane or desflurane in case of uterine atony (professional consensus). Severe bleeding during or after cesarean is a thrombotic risk factor and requires antithrombotic prophylaxis with heparin (the duration of treatment may vary depending on the associated risk factors) after normalization of coagulation (professional consensus). Postoperative hemoperitoneum (ultrasound) or suspected vascular wound require urgent laparotomy under general anesthesia (professional consensus). Otherwise, an uterotonic therapy (oxytocin or sulprostone depending on the severity) should be initiated. Balloon intrauterine tamponade or embolization may be discussed in the absence of hemodynamic instability (professional consensus). CONCLUSION: The occurrence of PPH associated with cesarean delivery requires close collaboration between obstetrician and anesthesiologist to ensure a rapid and coordinated management (professional consensus).

Accidental dural puncture: combination of prophylactic methods to avoid post-dural puncture headache.

Accidental dural puncture (ADP) is a common complication of epidural catheter insertion, and may lead to post-dural puncture headache (PDPH), especially in obstetric patients. Epidural blood patch (BP) is the most effective treatment of PDPH. Prophylactic BP has shown its efficacy to prevent PDPH; nevertheless, this method may be insufficient. We report an ADP case before induction of labor in a 28-year-old parturient. To avoid PDPH, an intrathecal catheter was immediately inserted after ADP and an epidural catheter was also inserted at the interspace above. Catheters were kept in place for more than 24hours. A prophylactic BP was performed immediately after removal of the intrathecal catheter. The patient did not experience any headache. This combination of treatments (intrathecal catheter insertion+prophylactic BP) may be a good alternative approach to prevent PDPH, even if it has to be warranted by other clinical studies.

[Pulmonary embolism and pregnancy]. / Embolie pulmonaire et grossesse.

OBJECTIVE: Pulmonary embolism remains a leading cause of maternal death in France and in other developed countries. Prevention is well codified, but management remains complex both for diagnosis and therapeutics. The objective of this review was to update the knowledge on diagnosis and treatment of pulmonary embolism during pregnancy. ARTICLE TYPE: Review. DATA SOURCE: Medline(®) database looking for articles published in English or French between 1965 and 2012, using pulmonary embolism, pregnancy, heparin, thrombolysis and vena cava filter as keywords. Editorials, original articles, reviews and cases reports were selected. DATA SYNTHESIS: Pulmonary embolism is one of the leading causes of maternal death in France. Clinical signs and biologic tests are not specific during pregnancy. Doppler ultrasound is helpful for diagnosis and avoids maternal and fetal radiation. Treatment is based on full anticoagulation. Low molecular weight heparin is the treatment of choice. A temporary vena cava filter may be proposed, especially at the end of pregnancy, or when heparin is contraindicated. In case of pulmonary embolism with cardiogenic shock, thrombolysis is an alternative treatment. CONCLUSION: Diagnostic approach is first based on the use of ultrasound- Doppler, and frequently on-to computed tomographic pulmonary angiography or ventilation-perfusion lung scanning. The treatment is based on low molecular weight heparin. Others therapeutics, such as thrombolysis or temporary vena cava filter, may be useful in certain circumstances.

[Labour epidural analgesia for a woman with hereditary macrothrombocytopenia]. / Analgésie péridurale obstétricale chez une patiente présentant une macrothrombocytopénie familiale.

Epidural analgesia is often considered as risk of epidural haematoma in a patient with thrombocytopenia. In this observation, uncomplicated epidural analgesia was performed in a pregnant woman with hereditary macrothrombocytopenia. She received continuous epidural labour analgesia for a vaginal delivery with a platelet count at 63x10(9)/l but platelets with high mean platelet volume (20fL) and normal function. No neurological sequelae or excessive bleeding occurred.

[Quality assurance program for pain management after obstetrical perineal injury]. / Programme d'assurance qualité pour la prise en charge de la douleur après lésions périnéales obstétricales.

INTRODUCTION: A quality insurance program has been set up in order to improve the relief of pain in patients with perineal injury after childbirth. PATIENTS AND METHODS: The program has been developed according to the French standards of accreditation. After elaboration of a referential, a first study (103 patients) allowed to evaluate the ongoing practices and to appreciate the pain intensities. After analysis of the results, an action strategy has been elaborated, with a brand new therapeutic standard and a pain-monitoring program for nurses. Six months later, a second study (105 patients) measured the efficiency of the accomplished actions. The statistic analysis used chi2 and Kruskal-Wallis tests and a multivariate analyse (p <0.05). RESULTS: Several indicators led to conclude to the success of this program: analgesics prescribed systematically and earlier, best observance, larger utilisation of the NSAI, decrease of the analgesics requests, improvement of the satisfaction referred to the relief of pain. The multivariate analyse showed a risk twice as little as in the second study to have a 36th hour VAS score superior to four (p =0.03). CONCLUSION: The apply of this quality insurance program allowed to improve the analgesia after obstetric perineal injuries. A few adaptations are needed, and also more formations of the medical and paramedical staff. The durability of the accomplished actions shall be evaluated in the future.

[Prevention strategies during pregnancy]. / Prise en charge anténatale: la gestion du risque.

This chapter deals with how to reduce, before delivery, postpartum hemorrhage. The strategy is explained for two risk levels, high and low. Means of prevention such as: logistical organisation; oral and parenteral iron therapy; erythropoietin; autologous blood transfusion; acute hemodilution; transfusion; bleeding disorders treatment; hospitalization, tocolysis, choice of mode of delivery, caesarean section and anaesthetic techniques for placenta praevia or accreta; interest of corticosteroids therapy and magnesium sulfate bleeding risks in severe pre-eclampsia, are addressed in turn. The chapter closes with professional recommendations ranked according levels of evidence founded in the literature.

Do prophylactic prostaglandins reduce the transfusion rate at cesarean section in high-order multiple pregnancies?

OBJECTIVE: Cesarean section is the more usual mode of delivery in high-order multiple pregnancy (> or =3). Excessive uterine distension increases the risk of bleeding and the need for transfusion. The aim of this study was to investigate if prophylactic use of prostaglandins at cesarean section for high-order multiple pregnancies reduces blood loss and transfusion requirement based on historic data. STUDY DESIGN: We studied a prospective series of 28 parturients with high-order multiple pregnancy (group 2) who were treated, after clamping the last umbilical cord, with oxytocin (5IU intravenous then 35IU in a 24h infusion) combined with intravenous prostaglandin. A comparable retrospective series of 14 patients (group 1) had been given oxytocin alone at the same dose. Postoperative serum hemoglobin and transfusion rate as well as adverse effects were compared between the two groups. Student's t-test was used to compare continuous variables. Chi square test and Fisher exact test were used to compare categorical variables. RESULTS: The two groups were comparable for anthropometric data and duration of pregnancy. None of the patients in group 2 required red cell transfusion while 21.4% of those in group 1 required transfusion. A significant lower decrease of postoperative haemoglobin is noted in group 2 (P=0.0006). Multivariate analysis using variables significant at univariate analysis and pre-eclampsia confirmed this difference. There were no adverse reactions to treatment. CONCLUSION: In our experience, prophylactic prostaglandin infusion at cesarean section in high-order multiple pregnancy is associated with a lower need for per operative red cell transfusion and a higher postoperative hemoglobin level. This observation merits confirmation in larger studies.

[General anaesthesia for Caesarean section in a patient with pulmonary atresia and an intact intraventricular septum]. / Anesthésie pour césarienne chez une patiente atteinte d'une atrésie pulmonaire à septum interventriculaire intact.

We report the case of a 22-year-old primigravida patient presenting pulmonary atresia with intact ventricular septum, a rare congenital heart disease. Caesarean delivery was performed at 32 weeks of gestation because of moderate maternal function deterioration and foetal growth restriction. General anaesthesia was used because of the presence of lumbar Harrington rods. The administration of etomidate, celocurine and a continuous perfusion of remifentanil right from induction ensured haemodynamic stability and a rapid emergence and recovery.

[Chest pain and sulprostone during postpartum hemorrhage]. / Angor et sulprostone au cours d'une hémorragie de la délivrance.

A case of chest pain in a 31-year-old woman after vaginal delivery with epidural analgesia during sulprostone administration is described. Chest pain occurred shortly after sulprostone was started and disappeared when sulprostone was stopped. Ischaemia related data were negative. Angiographically coronary arteries were normal. Coronary artery spasm aetiology was retained. Sulprostone pharmacology is summarized. Coronary artery effects are compared with literature reports. Recommendations before sulprostone use are underlined.

[Antipublic antibodies and pregnancy: use of iron sucrose in autologous blood donation with cryopreservation]. / Anticorps antipublic et grossesse: intérêt du fer intraveineux pour une autotransfusion avec cryoconservation.

An autologous blood donation with cryopreservation in a pregnant woman with natural antibody against a high frequency alloantigen is reported. A natural anti Gerbich antibody and a rare erythrocyte phenotype at high risk of polyimmunization was discovered during the third month of pregnancy. This leads to recommend the constitution of an autologous blood reserve. Before first sampling a moderate iron deficiency anaemia (10.3 g.dL-1) was treated with 600 mg of intravenous iron sucrose. Four blood packs of 350 mL were taken; after every sampling 200 mg of iron sucrose were injected intravenously. No maternal or foetal adverse effects occurred. Five weeks before delivery, an autologous blood reserve consisting in 4 cryopreserved red cells packs and 4 fresh frozen plasma was constituted. Epidural analgesia was used for delivery. No haemorrhage occurred. The reserve was not used and remained available for future use (one year for fresh frozen plasma and without limit for red cells).

Evaluation of the quality of care for severe obstetrical haemorrhage in three French regions.

OBJECTIVE: To determine what factors related to health services in France might explain substandard care of severe morbidity due to obstetric haemorrhage. DESIGN: Retrospective questionnaire survey. SETTING: Three administrative regions of France. POPULATION: All women who were pregnant or had recently given birth during the year before the survey. METHODS: A European survey (MOMS-B) defined severe haemorrhages as blood loss > or = 1500mL. A specific questionnaire was added in France to analyse the quality of care of these haemorrhages. The survey was carried out in three different administrative regions: Champagne-Ardenne, the Centre and Lorraine. An expert committee was appointed and began by establishing a framework for qualitative assessment. One hundred and sixty-five cases of severe haemorrhage were reviewed and classified into one of three levels of care: appropriate, inadequate or mixed. Inadequate care and 'mixed' care were both considered substandard. The 165 cases were coded and then studied with uni- and multivariate analysis (logistic regression with SAS and SPSS software). RESULTS: Of the 165 cases identified, 51% (85/165) were vaginal, 19% (31/165) operative vaginal, and 30% (49/165) caesarean. The leading cause of haemorrhage was uterine atony. Overall, 62% of the cases received appropriate care, 24% received totally inadequate care and 14% mixed care. After adjustment for sociodemographic factors, antenatal care and organisational aspects, the lack of a 24-hour on-site anaesthetist at the hospital and a low volume of deliveries (<500 births per year) were the factors associated with substandard care. CONCLUSION: Organisational features are so important that application of good clinical practices for safer motherhood reinforce the need for new organisation of obstetric services. For the first time, the presence of an anaesthetist is shown to have a measurable effect on the quality of care for women giving birth. These results need to be confirmed by others.

[Severe complications of pregnancy and delivery: the situation in Lorraine based on the European investigation]. / Les complications sévères de la grossesse et de l'accouchement: état des lieux en Lorraine dans le cadre de l'enquête européenne.

The level of maternal mortality appears to be higher in France than in other European countries according to the data collected in the 1995 European survey. We performed a retrospective analysis of severe hemorrhage, pregnancy induced hypertension, and maternal sepsis in 1995 in the Lorraine region and reviewed the management scheme used in each case. There was one maternal death and 223 cases of severe maternal morbidity (110 cases of hemorrhage, 105 cases of pregnancy induced hypertension, 8 cases of maternal sepsis). The frequency of these maternal diseases was an estimated 8 per 1000 births. Ninety percent of the children (90.7%) were living 7 days after birth. Pregnancy after the age of 35 years, obesity, and an intermediate level of vocational training were well-documented high risk factors in the Lorraine area. All of the women who developed complications had been followed regularly during their pregnancy. High parity and a scarred uterus were high risk factors for post partum hemorrhage. About 45% (45.5%) of the patients were transferred to an emergency unit for intensive care. Pregnancy-induced hypertension was treated within the normal hospital network, most of the mothers being transferred to a reference center prior to delivery. This retrospective study demonstrates the need for reporting more information on medical records. The data observed improved our knowledge of the prevalence and management of the main causes of direct maternal death in the Lorraine area. It improved our knowledge on the prevalence and management of the main causes of direct maternal death in Lorraine area.

[Avoidable anesthetic complications and their prevention]. / Les complications anesthésiques évitables et leur prévention.

Anesthesia-related mortality in France is being studied in a survey that began in 1996 using the United Kingdom survey as a model. We describe here the deaths reported in these two surveys and discuss the management strategies involved. These cases point out the risk involved with aspiration syndrome, difficult intubation, cardiac toxicity of local anesthetics, total spinal anesthesia, and respiratory depression. The methodology of the French maternal mortality survey provides data enabling the institution of preventive measures. Specific actions, some of which would require legislation, are proposed to improve maternal safety.