René-Charles Rudigoz

Postpartum hemorrhage resulting from uterine atony after vaginal delivery: factors associated with severity.

OBJECTIVE: To identify factors associated with severity of postpartum hemorrhage among characteristics of women and their delivery, the components of initial postpartum hemorrhage management, and the organizational characteristics of maternity units. METHODS: This population-based cohort study included women with postpartum hemorrhage due to uterine atony after vaginal delivery in 106 French hospitals between December 2004 and November 2006 (N=4,550). Severe postpartum hemorrhage was defined by a peripartum change in hemoglobin of 4 g/dL or more. A multivariable logistic model was used to identify factors independently associated with postpartum hemorrhage severity. RESULTS: Severe postpartum hemorrhage occurred in 952 women (20.9%). In women with postpartum hemorrhage, factors independently associated with severity were: primiparity; previous postpartum hemorrhage; previous cesarean delivery; cervical ripening; prolonged labor; and episiotomy; and delay in initial care for postpartum hemorrhage. Also associated with severity was 1) administration of oxytocin more than 10 minutes after postpartum hemorrhage diagnosis: 10–20 minutes after, proportion with severe postpartum hemorrhage 24.6% compared with 20.5%, adjusted OR 1.38, 95% CI 1.03–1.85; more than 20 minutes after, 31.8% compared with 20.5%, adjusted OR 1.86, CI 1.45–2.38; 2) manual examination of the uterine cavity more than 20 minutes after (proportion with severe postpartum hemorrhage 28.2% versus 20.7%, adjusted OR 1.83, 95% CI 1.42–2.35); 3) call for additional assistance more than 10 minutes after (proportion with severe postpartum hemorrhage 29.8% versus 24.8%, adjusted OR 1.61, 95% CI 1.23–2.12 for an obstetrician, and 35.1% compared with 29.9%, adjusted OR 1.51, 95% CI 1.14–2.00 for an anesthesiologist); 4) and delivery in a public non-university hospital. Epidural analgesia was found to be a protective factor against severe blood loss in women with postpartum hemorrhage. CONCLUSION: Aspects of labor, delivery, and their management; delay in initial care; and place of delivery are independent risk factors for severe blood loss in women with postpartum hemorrhage caused by atony. LEVEL OF EVIDENCE: II

Oxytocin during labour and risk of severe postpartum haemorrhage: a population-based, cohort-nested case–control study

Objectives Postpartum haemorrhage (PPH) is a major cause of maternal mortality and morbidity worldwide. Experimental studies support the hypothesis that oxytocin administration during labour, a common although not evidence-based practice, may increase the risk of atonic PPH. The clinical studies, however, are inconclusive. The objectives of this study was to investigate the association between the level of oxytocin exposure during labour and the risk of severe PPH and to explore whether the prophylactic use of oxytocin after birth modifies this association. Design Population-based, cohort-nested case–control study. Setting 106 French hospitals from December 2004 through November 2006. Participants Women with term singleton vaginal deliveries, after an uncomplicated pregnancy. Cases were 1483 women with severe PPH, defined by peripartum change in haemoglobin of ≥4 g/dl or need for blood transfusion. Controls were 1758 women from a random sample of parturients without PPH. Main outcome measures The independent association between the level of oxytocin during labour and the risk of severe PPH was tested and quantified with ORs through two-level multivariable logistic regression modelling. Results Oxytocin was administered during labour to 73% of cases and 61% of controls (crude OR: 1.7, 95% CI 1.5 to 2.0). After adjustment for all potential confounders, oxytocin during labour was associated with a significantly higher risk of severe PPH (adjusted OR: 1.8, 95% CI 1.3 to 2.6) in women who did not receive prophylactic oxytocin after delivery; the OR for haemorrhage increased from 1 to 5 according to the level of oxytocin exposure. In women who had prophylactic oxytocin after delivery, this association was significant only for the highest exposure categories. Conclusions Oxytocin during labour appears to be an independent risk factor for severe PPH. The results emphasise the need for guidelines clarifying the evidence-based indications for this procedure and the minimal useful regimens.

Coagulation assessment by rotation thrombelastometry in normal pregnancy

We analysed changes in coagulation during normal pregnancy with a novel point-of-care device based on thrombelastometry (ROTEM). We compared the results obtained with those of standard coagulation tests in 104 patients: 20 non-pregnant women (controls) and 84 women in the first (T1, n = 17), second (T2, n = 9) and third (T3, n = 58) trimesters of pregnancy. We measured the clotting time (CT), the maximum clot firmness (MCF), the early clot amplitude at 5 and 15 minutes (CA(5), CA(15)) and the clot lysis index (CLI(30)) with four tests containing specific reagents. (a) The INTEM test involving ellagic acid activated the intrinsic pathway and (b) the EXTEM test using tissue factor triggered the extrinsic pathway; (c) The FIBTEM test based on a platelet inhibitor (cytochalasin D) evaluated the contribution of fibrinogen to clot formation and (d) the APTEM test was similar to the EXTEM but was based on inhibition in vitro of fibrinolysis by aprotinin. CT and CLI(30) were not significantly modified during pregnancy whereas MCF, CA(5) and CA(15) (INTEM, EXTEM, FIBTEM) increased significantly between the second and third trimesters (e.g. median [interquartile range]: MCF-FIBTEM, 13 [11-16] mm vs. 19 [17-23] mm, respectively, in controls and T3, p < 0.001). EXTEM values were not significantly different from those measured with APTEM. There were significant correlations between the results obtained with ROTEM and those from standard coagulation tests. ROTEM analysis showed a marked increase in coagulability during normal pregnancy. ROTEM values may serve as the basis for future studies in pregnant women.

Nutritional and genetic determinants of vitamin B and homocysteine metabolisms in neural tube defects: A multicenter case–control study†

Neural tube defects (NTDs) are severe congenital malformations due to failure of neural tube formation in early pregnancy. The proof that folic acid prevents NTDs raises the question of whether other parts of homocysteine (Hcy) metabolism may affect rates of NTDs. This French case‐control study covered: 77 women aged 17–42 years sampled prior to elective abortion for a severe NTDs (cases) and 61 women aged 20–43 years with a normal pregnancy. Plasma and erythrocyte folate, plasma B6, B12 and Hcy were tested as five polymorphisms MTHFR 677 C → T, MTHFR 1298 A → C, MTR 2756 A → G, MTTR 66 A → G and TCN2 776 C → G. Cases had significantly lower erythrocyte folate, plasma folate, B12 and B6 concentrations than the controls, and higher Hcy concentration. The odds ratio was 2.15 (95% CI: 1.00–4.59) for women with the MTRR 66 A → G allele and it was decreased for mothers carrying the MTHFR 1298 A → C allele. In multivariate analysis, only the erythrocyte folate concentration (P = 0.005) and plasma B6 concentration (P = 0.020) were predictors. Red cell folate is the main determinant of NTDs in France. Folic acid supplement or flour fortification would prevent most cases. Increased consumption of vitamins B12 and B6 could contribute to the prevention of NTDs. Genetic polymorphisms played only a small role. Until folic acid fortification becomes mandatory, all women of reproductive age should consume folic acid in a multivitamin that also contains B12 and B6.

Incidence and management of postpartum haemorrhage following the dissemination of guidelines in a network of 16 maternity units in France

BACKGROUND In France obstetric haemorrhage is the leading cause of maternal death. The aim of this study was to evaluate if the management of postpartum haemorrhage at individual maternity units followed guidelines established by the Aurore Network. METHODS A descriptive study was carried out in 16 maternity units of the Aurore network between October 2004 and September 2005. Cases and data were prospectively identified and collected. RESULTS Postpartum haemorrhage occurred in 1144 of 21 350 deliveries, an overall incidence of 5.4+/-0.3%. Of these, 316 cases were rated as severe. Diagnosis was clinical in 82.5% of severe cases and 77.5% of non-severe cases; the remainder were detected by postpartum laboratory tests. Uterotonic agents were given prophylactically to 46.7% of the 896 patients following vaginal delivery. In cases in which postpartum haemorrhage was due to uterine atony, 83.1% of women underwent examination of the uterine cavity and 96.3% received oxytocin, which proved therapeutic. Sulprostone was administered to 39.5% cases of persistent postpartum haemorrhage. A uterotonic was given prophylactically to 85.4% of the 247 patients at caesarean delivery. Oxytocin was therapeutic in 94.8% of cases of uterine atony. Sulprostone was administered in 84.4% of cases of persistent postpartum haemorrhage. CONCLUSION The regional guidelines issued by the Aurore network were only partially followed. More effective guideline dissemination and implementation is required to improve the prevention and management of confirmed haemorrhage.

Comparative study of three vaginal markers of the premature rupture of membranes: Insulin like growth factor binding protein 1 Diamine‐oxidase pH

Objective. To assess the diagnostic value of three vaginal markers ‐ insulin‐like growth factor binding protein 1 (=1GFBP1), diamine‐oxidase (=DAO) and pH ‐ for diagnosis of the premature rupture of membranes.

Red, orange and green Caesarean sections: A new communication tool for on-call obstetricians

OBJECTIVE To evaluate the effect of a novel communication tool, related to the degree of urgency for Caesarean sections (CSs), on the decision-to-delivery interval for emergency CS. STUDY DESIGN Red CS are very urgent cases corresponding to life-threatening maternal or foetal situations, orange CS are urgent cases and green CS are non-urgent intrapartum CS. We carried out this cohort study in a French maternity hospital. The study included all emergency Caesarean sections during two 6-month periods, before and after introduction of the code. We compared the decision-to-delivery interval of the two study periods. RESULTS Our study included 174 emergency CS. The mean decision-to-delivery interval after introduction of the code was 31.7 min, significantly shorter (p=0.02) than the 39.6 min interval before introduction of the colour code. Except for the preparation time, each time interval decreased. This included transporting the patient into the operating theatre, and the incision-to-delivery time interval. CONCLUSION This study suggests that the use of the three-colour code could significantly shorten the decision-to-delivery interval in emergency CS. Further prospective studies are needed to confirm this result.

In Situ Simulation Training for Neonatal Resuscitation: An RCT

OBJECTIVES: High-fidelity simulation is an effective tool in teaching neonatal resuscitation skills to professionals. We aimed to determine whether in situ simulation training (for ∼80% of the delivery room staff) improved neonatal resuscitation performed by the staff at maternities. METHODS: A baseline evaluation of 12 maternities was performed: a random sample of 10 professionals in each unit was presented with 2 standardized scenarios played on a neonatal high-fidelity simulator. The medical procedures were video recorded for later assessments. The 12 maternities were then randomly assigned to receive the intervention (a 4-hour simulation training session delivered in situ for multidisciplinary groups of 6 professionals) or not receive it. All maternities were evaluated again at 3 months after the intervention. The videos were assessed by 2 neonatologists blinded to the pre-/postintervention as well as to the intervention/control groups. The performance was assessed using a technical score and a team score. RESULTS: After intervention, the median technical score was significantly higher for scenarios 1 and 2 for the intervention group compared with the control group (P = .01 and 0.004, respectively), the median team score was significantly higher (P < .001) for both scenarios. In the intervention group, the frequency of achieving a heart rate >90 per minute at 3 minutes improved significantly (P = .003), and the number of hazardous events decreased significantly (P < .001). CONCLUSIONS: In situ simulation training with multidisciplinary teams can effectively improve technical skills and teamwork in neonatal resuscitation.

Obstetrical prognosis of the septate uterus: a plea for treatment of the septum.

OBJECTIVE To evaluate the obstetrical and perinatal implications of the septate uterus and assess the improvements of the prognosis after treatment of the septum. INVESTIGATION This retrospective investigation was carried out in a single centre on 78 patients with septate uterus who had previously been correctly classified. A total of 203 pregnancies were observed. All complications occurring during the first, second and third trimesters and the neonatal outcome were logged. Furthermore, 25 patients in this sample underwent surgery which enabled reassessment of the obstetric and neonatal outcome. RESULTS Prior to surgery, during the 203 pregnancies, the fetal loss rate during the first two trimesters was 47%, prematurity 17% and 89 children were alive, i.e. an overall perinatal mortality rate of 16.8% when pregnancy exceeded 24 weeks. After surgical treatment of the septum, the proportion of pregnancies proceeding subsequent to 24 weeks and infant survival changed, respectively, from 13.3% to 90% and from 4.4% to 87.5%. CONCLUSION The obstetric and neonatal prognosis of septate uteruses is extremely unfavourable. This is radically transformed by treating the septum.

Induction of labor and risk of postpartum hemorrhage in low risk parturients.

Objective Labor induction is an increasingly common procedure, even among women at low risk, although evidence to assess its risks remains sparse. Our objective was to assess the association between induction of labor and postpartum hemorrhage (PPH) in low-risk parturients, globally and according to its indications and methods. Method Population-based case-control study of low-risk women who gave birth in 106 French maternity units between December 2004 and November 2006, including 4450 women with PPH, 1125 of them severe, and 1744 controls. Indications for labor induction were standard or non-standard, according to national guidelines. Induction methods were oxytocin or prostaglandins. Multilevel multivariable logistic regression modelling was used to test the independent association between induction and PPH, quantified as odds ratios. Results After adjustment for all potential confounders, labor induction was associated with a significantly higher risk of PPH (adjusted odds ratio, AOR1.22, 95%CI 1.04–1.42). This excess risk was found for induction with both oxytocin (AOR 1.52, 95%CI 1.19–1.93 for all and 1.57, 95%CI 1.11–2.20 for severe PPH) and prostaglandins (AOR 1.21, 95%CI 0.97–1.51 for all and 1.42, 95%CI 1.04–1.94 for severe PPH). Standard indicated induction was significantly associated with PPH (AOR1.28, 95%CI 1.06–1.55) while no significant association was found for non-standard indicated inductions. Conclusion Even in low risk women, induction of labor, regardless of the method used, is associated with a higher risk of PPH than spontaneous labor. However, there was no excess risk of PPH in women who underwent induction of labor for non-standard indications. This raises the hypothesis that the higher risk of PPH associated with labor induction may be limited to unfavorable obstetrical situations.