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

International audienceBACKGROUND: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)

Ressources humaines pour les activités non programmées en gynécologie-obstétrique. Propositions élaborées par le CNGOF, le CARO, le CNSF, la FFRSP, la SFAR, la SFMP et la SFN

National audienceObjective. - To determine a minimum threshold of human resources (midwives, obstetricians and gynecologists, anesthesiology and intensive care units, pediatricians) to ensure the safety and quality of unplanned activities in Obstetrics and Gynecology. Materials and methods. - Consultation of the MedLine database, the Cochrane Library and the recommendations of authorities. Meetings of representative members in different modes of practice (university, hospital, liberal) under the aegis of and belonging to the French College of Obstetricians and Gynecologists (CNGOF), the French Society of Anesthesia and Resuscitation (SFAR), the French Society of Neonatalogy (SFN), the French Society of Perinatal Medicine (SFMP), the French College of Midwives (CNSF), the French Federation of Perinatal Care Networks (FFRSP) with elaboration of a re-read text by external experts, in particular by the members of the Boards of Directors of these authorities and of Club of Anesthesiology-Intensive Care Medicine in Obstetrics (CARO). Results. - Different minimum thresholds for each category of caregivers were proposed based on the number of births/year. These proposed minimum thresholds can be modulated upwards according to the types (level I, IIA, IIB or III) or the activity (existence of an emergency reception service, maternalfetal and/or surgical activity of resort or referral). Due to peak activity and the possibility of unpredictable concomitance of urgent medical procedures, it is necessary that organizations plan to use resource persons. The occupancy rate of the target beds of a maternity ward must be 85%. Conclusion. - These proposed minimum thresholds are intended to help caregivers providing nonscheduled perinatal as well as Obstetrics and Gynecology care to make the most of the human resources allocated to institutional bodies to ensure their safety and quality

Recombinant human FVIIa for reducing the need for invasive second-line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial

Case reports on recombinant human factor VIIa (rhuFVIIa) use in women with severe postpartum hemorrhage (PPH) showed encouraging results, but no randomized controlled trial (RCT) is available

Postauthorization safety study of Clottafact ® , a triply secured fibrinogen concentrate in acquired fibrinogen deficiency: a prospective observational study

International audienceBACKGROUND AND OBJECTIVES:A postauthorization safety study was performed between 2009 and 2012 to describe the use of Clottafact® in acquired fibrinogen deficiency in real-life medical practice in France.MATERIALS AND METHODS:One hundred and fifty patients were planned for 28 days of prospective follow-up after infusion. The analysis of this observational study was descriptive and performed according to the type of treatment (curative or preventive) and the origin of the bleed.RESULTS:One hundred and fifty-six patients (16-87 years) were included in 13 centres and treated in five different medical bleeding situations: postpartum (59), other gynaecological/obstetrical (6), trauma (34), liver (13), cardiovascular (23) and other various bleeding situations (21). The mean follow-up time was 18·9 ± 12·3 days. Two patients presented adverse drug reactions: one a pulmonary embolism and the other a four-site venous thromboembolic episode. All were serious with a dubious causal relationship with the study treatment. Efficacy data were collected as a secondary objective. In 150 patients receiving curative treatment, 117 of 159 infusions (73·6%) were considered as successful by the investigators, 35 as moderate (22%) and seven as no response (4·4%).CONCLUSION:The Clottafact® safety profile observed during the study matched the known profile of fibrinogen during use

Core outcome sets for prevention and treatment of postpartum haemorrhage: An international delphi consensus study

Objective: To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of PPH, and recommendations on how to report the COS.Design: A two-round Delphi survey and face-to-face meeting.Population: Health care professionals and women\u27s representatives.Methods: Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7-9). Lectures, discussion and voting were used to agree how to report COS outcomes.Main outcome Measures: outcomes from systematic reviews and consultations. Results: Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women\u27s sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women\u27s sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding and adverse effects. Recommendations were developed on how to report these outcomes where possible.Conclusions: These COS will help standardise outcome reporting in PPH trials. This article is protected by copyright. All rights reserved