Risk factors for placenta accreta spectrum disorders in women with any prior cesarean and a placenta previa or low lying: a prospective population-based study.

This study aimed to identify the risk factors for placenta accreta spectrum (PAS) in women who had at least one previous cesarean delivery and a placenta previa or low-lying. The PACCRETA prospective population-based study took place in 12 regional perinatal networks from 2013 through 2015. All women with one or more prior cesareans and a placenta previa or low lying were included. Placenta accreta spectrum (PAS) was diagnosed at delivery according to standardized clinical and histological criteria. Of the 520,114 deliveries, 396 fulfilled inclusion criteria; 108 were classified with PAS at delivery. Combining the number of prior cesareans and the placental location yielded a rate ranging from 5% for one prior cesarean combined with a posterior low-lying placenta to 63% for three or more prior cesareans combined with placenta previa. The factors independently associated with PAS disorders were BMI ≥ 30, previous uterine surgery, previous postpartum hemorrhage, a higher number of prior cesareans, and a placenta previa. Finally, in this high-risk population, the rate of PAS disorders varies greatly, not only with the number of prior cesareans but also with the exact placental location and some of the women's individual characteristics. Risk stratification is thus possible in this population.

Association Between Surgeon Gender and Maternal Morbidity After Cesarean Delivery.

Importance: The stereotype that men perform surgery better than women is ancient. Surgeons have long been mainly men, but in recent decades an inversion has begun; the number of women surgeons is increasing, especially in obstetrics and gynecology. Studies outside obstetrics suggest that postoperative morbidity and mortality may be lower after surgery by women. Objective: To evaluate the association between surgeons' gender and the risks of maternal morbidity and postpartum hemorrhage (PPH) after cesarean deliveries. Design, Setting, and Participants: This prospective cohort study was based on data from the Tranexamic Acid for Preventing Postpartum Hemorrhage after Cesarean Delivery (TRAAP2) trial, a multicenter, randomized, placebo-controlled trial that took place from March 2018 through January 2020 (23 months). It aimed to investigate whether the administration of tranexamic acid plus a prophylactic uterotonic agent decreased PPH incidence after cesarean delivery compared with a uterotonic agent alone. Women having a cesarean delivery before or during labor at or after 34 weeks' gestation were recruited from 27 French maternity hospitals. Exposures: Self-reported gender (man or woman), assessed by a questionnaire immediately after delivery. Main Outcomes and Measures: The primary end point was the incidence of a composite maternal morbidity variable, and the secondary end point was the incidence of PPH (the primary outcome of the TRAAP2 trial), defined by a calculated estimated blood loss exceeding 1000 mL or transfusion by day 2. Results: Among 4244 women included, men surgeons performed 943 cesarean deliveries (22.2%) and women surgeons performed 3301 (77.8%). The rate of attending obstetricians was higher among men (441 of 929 [47.5%]) than women (687 of 3239 [21.2%]). The risk of maternal morbidity did not differ for men and women surgeons: 119 of 837 (14.2%) vs 476 of 2928 (16.3%) (adjusted risk ratio, 0.92 [95% CI, 0.77-1.13]). Interaction between surgeon gender and level of experience on the risk of maternal morbidity was not statistically significant. Similarly, the groups did not differ for PPH risk (adjusted risk ratio, 0.98 [95% CI, 0.85-1.13]). Conclusions and Relevance: Risks of postoperative maternal morbidity and of PPH exceeding 1000 mL or requiring transfusion by day 2 did not differ by the surgeon's gender.

Acute coronary syndrome during pregnancy and postpartum in France: the nationwide CONCEPTION study.

BACKGROUND: Cardiovascular diseases, including acute coronary syndromes, are the leading cause of maternal death in many developed countries. OBJECTIVE: We assessed acute coronary syndrome incidences during pregnancy, peripartum, and postpartum periods. We also compared overall pregnancy (ie, covering all 3 periods) incidence with that found in nonpregnant women of childbearing age. STUDY DESIGN: All women aged between 15 and 49 years without ischemic heart disease who delivered between 2010 and 2018 in France were included in the CONCEPTION cohort. Data were extracted from the French National Health Insurance Information System database. Acute coronary syndromes were defined according to the International Classification of Diseases, Tenth Revision codes recorded in the principal hospital diagnosis. We used Poisson regression to estimate crude acute coronary syndrome incidences, and tested age-adjusted Poisson models to compare the incidence risk ratio of acute coronary syndrome between pregnant and nonpregnant women, with 95% confidence intervals. RESULTS: Among 6,298,967 deliveries in France, we observed 225 first-time acute coronary syndrome diagnoses during overall pregnancy (overall pregnancy-related acute coronary syndrome incidence, 4.34/100,000 person-years; 1 case/23,000 pregnancies). In multivariate analysis, independent factors associated with acute coronary syndrome were age, social deprivation, obesity, tobacco use, chronic hypertension, and hypertensive disorders of pregnancy (all P<.05). Among the nonpregnant women aged 15 to 49 years in the general French population, 18,247 cases of acute coronary syndrome (incidence, 16.5/100,000 person-years) occurred throughout the whole study period (>100 million person-years). Compared with the acute coronary syndrome incidence in nonpregnant women, age-adjusted overall pregnancy-related acute coronary syndrome incidence was lower (incidence rate ratio, 0.76; 95% confidence interval, 0.57-0.98; P<.05). Although compared with nonpregnant women, age-adjusted incidence rates were lower during pregnancy, risk was increased during peripartum and postpartum periods. CONCLUSION: With an incidence of 4.34 per 100,000 person-years, acute coronary syndrome still accounts for a significant proportion of maternal mortality. The peripartum and postpartum periods remain high-risk periods, and greater efforts should be made in terms of acute coronary syndrome prevention, especially because several cardiovascular risk factors are treatable, such as tobacco use and hypertensive disorders of pregnancy.

Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial.

BACKGROUND: Although prophylactic tranexamic acid administration after cesarean delivery resulted in a lower incidence of calculated estimated blood loss of >1000 mL or red cell transfusion by day 2, its failure to reduce the incidence of hemorrhage-related secondary clinical outcomes (TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial) makes its use questionable. The magnitude of its effect may differ in women at higher risk of blood loss, including those with multiple pregnancies. OBJECTIVE: This study aimed to compare the effect of tranexamic acid vs placebo to prevent blood loss after cesarean delivery among women with multiple pregnancies. STUDY DESIGN: This was a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial data, a double-blind, randomized controlled trial from March 2018 to January 2020 in 27 French maternity hospitals, that included 319 women with multiple pregnancies. Women with a cesarean delivery before or during labor at ≥34 weeks of gestation were randomized to receive intravenously 1 g of tranexamic acid (n=160) or placebo (n=159), both with prophylactic uterotonics. The primary outcome was a calculated estimated blood loss of >1000 mL or a red blood cell transfusion by 2 days after delivery. The secondary outcomes included clinical and laboratory blood loss measurements. RESULTS: Of the 4551 women randomized in this trial, 319 had a multiple pregnancy and cesarean delivery, and 298 (93.4%) had primary outcome data available. This outcome occurred in 62 of 147 women (42.2%) in the tranexamic acid group and 67 of 152 (44.1%) receiving placebo (adjusted risk ratio, 0.97; 95% confidence interval, 0.68-1.38; P=.86). No significant between-group differences occurred for any hemorrhage-related clinical outcomes: gravimetrically estimated blood loss, provider-assessed clinically significant hemorrhage, additional uterotonics, postpartum blood transfusion, arterial embolization, and emergency surgery (P>.05 for all comparisons). CONCLUSION: Among women with a multiple pregnancy and cesarean delivery, prophylactic tranexamic acid did not reduce the incidence of any blood loss-related outcomes.

World Health Organization Recommendation for Using Uterine Balloon Tamponade to Treat Postpartum Hemorrhage.

The World Health Organization (WHO) recently published a new recommendation on the use of the uterine balloon tamponade for the treatment of postpartum hemorrhage. The recommendation that uterine balloon tamponade should be used only where there is already access to other postpartum hemorrhage treatments (including immediate recourse to surgery) has proved controversial. It is especially problematic for those working in low-level health care facilities in under-resourced settings, where there are already programs that have introduced low-cost uterine balloon tamponade devices for use, even in settings where recourse to surgical interventions is not possible. However, there are now two separate randomized trials that both unexpectedly show unfavorable outcomes in these settings when a condom catheter uterine balloon tamponade device was introduced. Considering the balance of potential benefits and these safety concerns, the WHO postpartum hemorrhage guideline panel therefore recommends that uterine balloon tamponade should be used only in contexts where other supportive postpartum hemorrhage interventions are available if needed.

Characterisation of a high-risk profile for maternal thrombotic and severe haemorrhagic complications in pregnant women with antiphospholipid syndrome in France (GR2): a multicentre, prospective, observational study.

BACKGROUND: Prospective data about the risks of thrombotic and severe haemorrhagic complications during pregnancy and post partum are unavailable for women with antiphospholipid syndrome. We aimed to assess thrombotic and haemorrhagic events in a prospective cohort of pregnant women with antiphospholipid syndrome. METHODS: This multicentre, prospective, observational study was done at 76 centres in France. To be eligible for this study, women had to have diagnosis of antiphospholipid syndrome; have conceived before April 17, 2020; have an ongoing pregnancy that had reached 12 weeks of gestation; and be included in the study before 18 weeks of gestation. Exclusion criteria were active systemic lupus erythematosus nephropathy, or a multifetal pregnancy. Severe haemorrhage was defined as the need for red blood cell transfusion or maternal intensive care unit admission because of bleeding or invasive procedures, defined as interventional radiology or surgery, to control bleeding. The GR2 study is registered with ClinicalTrials.gov, NCT02450396. FINDINGS: Between May 26, 2014, and April 17, 2020, 168 pregnancies in 27 centres met the inclusion criteria for the study. 89 (53%) of 168 women had a history of thrombosis. The median term at inclusion was 8 weeks gestation. 16 (10%) of 168 women (95%CI 5-15) had a thrombotic (six [4%] women; 95% CI 1-8) or severe haemorrhagic event (12 [7%] women; 95% CI 4-12). There were no deaths during the study. The main risk factors for thrombotic events were lupus anticoagulant positivity at inclusion (six [100%] of six women with thrombosis vs 78 [51%] of 152 of those with no thrombosis; p=0·030) and placental insufficiency (four [67%] of six women vs 28 [17%] of 162 women; p=0·013). The main risk factors for severe haemorrhagic events were pre-existing maternal hypertension (four [33%] of 12 women vs 11 [7%] of 156 women; p=0·014), lupus anticoagulant positivity at inclusion (12 [100%] of 12 women vs 72 [49%] of 146 women; p<0·0001) and during antiphospholipid history (12 [100%] of 12 women vs 104 [67%] of 156 women; p=0·019), triple antiphospholipid antibody positivity (eight [67%] of 12 women vs 36 [24%] of 147 women; p=0·0040), placental insufficiency (five [42%] of 12 women vs 27 [17%] of 156 women; p=0·038), and preterm delivery at 34 weeks or earlier (five [45%] of 11 women vs 12 [8%] of 145 women; p=0·0030). INTERPRETATION: Despite treatment adhering to international recommendations, a proportion of women with antiphospholipid syndrome developed a thrombotic or severe haemorrhagic complication related to pregnancy, most frequently in the post-partum period. Lupus anticoagulant and placental insufficiency were risk factors for these life-threatening complications. These complications are difficult to prevent, but knowledge of the antenatal characteristics associated with them should increase awareness and help physicians manage these high-risk pregnancies. FUNDING: Lupus France, association des Sclérodermiques de France, association Gougerot Sjögren, Association Francophone contre la Polychondrite chronique atrophiante, AFM-Telethon, the French Society of Internal Medicine and Rheumatology, Cochin Hospital, the French Health Ministry, FOREUM, the Association Prix Veronique Roualet, and UCB.

Caesarean Delivery and Postpartum Maternal Mortality: A Population-Based Case Control Study in Brazil.

BACKGROUND: Cesarean delivery rates continue to increase worldwide and reached 57% in Brazil in 2014. Although the safety of this surgery has improved in the last decades, this trend is a concern because it carries potential risks to women's health and may be a modifiable risk factor of maternal mortality. This paper aims to investigate the risk of postpartum maternal death directly associated with cesarean delivery in comparison to vaginal delivery in Brazil. METHODS: This was a population-based case-control study performed in eight Brazilian states. To control for indication bias, deaths due to antenatal morbidity were excluded. We included 73 cases of postpartum maternal deaths from 2009-2012. Controls were selected from the Birth in Brazil Study, a 2011 nationwide survey including 9,221 postpartum women. We examined the association of cesarean section and postpartum maternal death by multivariate logistic regression, adjusting for confounders. RESULTS: After controlling for indication bias and confounders, the risk of postpartum maternal death was almost three-fold higher with cesarean than vaginal delivery (OR 2.87, 95% CI 1.63-5.06), mainly due to deaths from postpartum hemorrhage and complications of anesthesia. CONCLUSION: Cesarean delivery is an independent risk factor of postpartum maternal death. Clinicians and patients should consider this fact in balancing the benefits and risks of the procedure.

Postpartum hemorrhage: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF): in collaboration with the French Society of Anesthesiology and Intensive Care (SFAR).

Postpartum haemorrhage (PPH) is defined as blood loss ≥500mL after delivery and severe PPH as blood loss ≥1000mL, regardless of the route of delivery (professional consensus). The preventive administration of uterotonic agents just after delivery is effective in reducing the incidence of PPH and its systematic use is recommended, regardless of the route of delivery (Grade A). Oxytocin is the first-line prophylactic drug, regardless of the route of delivery (Grade A); a slowly dose of 5 or 10 IU can be administered (Grade A) either IV or IM (professional consensus). After vaginal delivery, routine cord drainage (Grade B), controlled cord traction (Grade A), uterine massage (Grade A), and routine bladder voiding (professional consensus) are not systematically recommended for PPH prevention. After caesarean delivery, placental delivery by controlled cord traction is recommended (grade B). The routine use of a collector bag to assess postpartum blood loss at vaginal delivery is not systematically recommended (Grade B), since the incidence of severe PPH is not affected by this intervention. In cases of overt PPH after vaginal delivery, placement of a blood collection bag is recommended (professional consensus). The initial treatment of PPH consists in a manual uterine examination, together with antibiotic prophylaxis, careful visual assessment of the lower genital tract, a uterine massage, and the administration of 5-10 IU oxytocin injected slowly IV or IM, followed by a maintenance infusion not to exceed a cumulative dose of 40IU (professional consensus). If oxytocin fails to control the bleeding, the administration of sulprostone is recommended within 30minutes of the PPH diagnosis (Grade C). Intrauterine balloon tamponade can be performed if sulprostone fails and before recourse to either surgery or interventional radiology (professional consensus). Fluid resuscitation is recommended for PPH persistent after first line uterotonics, or if clinical signs of severity (Grade B). The objective of RBC transfusion is to maintain a haemoglobin concentration (Hb) >8g/dL. During active haemorrhaging, it is desirable to maintain a fibrinogen level ≥2g/L (professional consensus). RBC, fibrinogen and fresh frozen plasma (FFP) may be administered without awaiting laboratory results (professional consensus). Tranexamic acid may be used at a dose of 1 g, renewable once if ineffective the first time in the treatment of PPH when bleeding persists after sulprostone administration (professional consensus), even though its clinical value has not yet been demonstrated in obstetric settings. It is recommended to prevent and treat hypothermia in women with PPH by warming infusion solutions and blood products and by active skin warming (Grade C). Oxygen administration is recommended in women with severe PPH (professional consensus). If PPH is not controlled by pharmacological treatments and possibly intra-uterine balloon, invasive treatments by arterial embolization or surgery are recommended (Grade C). No technique for conservative surgery is favoured over any other (professional consensus). Hospital-to-hospital transfer of a woman with a PPH for embolization is possible once hemoperitoneum is ruled out and if the patient's hemodynamic condition so allows (professional consensus).

Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial.

BACKGROUND: Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Estimates of its incidence in the literature vary widely, from 3 % to 15 % of deliveries. Uterotonics after birth are the only intervention that has been shown to be effective in preventing PPH. Tranexamic acid (TXA), an antifibrinolytic agent, has been investigated as a potentially useful complement to uterotonics for prevention because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention after cesarean (n = 10) and vaginal (n = 2) deliveries show that women who received TXA had significantly less postpartum blood loss without any increase in their rate of severe adverse effects. However, the quality of these trials was poor and they were not designed to test the effect of TXA on the reduction of PPH incidence. Large, adequately powered, multicenter randomized controlled trials are required before the widespread use of TXA to prevent PPH can be recommended. METHODS AND DESIGN: A multicenter, double-blind, randomized controlled trial will be performed. It will involve 4000 women in labor for a planned vaginal singleton delivery, at a term ≥ 35 weeks. Treatment (either TXA 1 g or placebo) will be administered intravenously just after birth. Prophylactic oxytocin will be administered to all women. The primary outcome will be the incidence of PPH, defined by blood loss ≥500 mL, measured with a graduated collector bag. This study will have 80 % power to show a 30 % reduction in the incidence of PPH, from 10.0 % to 7.0 %. DISCUSSION: In addition to prophylactic uterotonic administration, a complementary component of the management of third stage of labor acting on the coagulation process may be useful in preventing PPH. TXA is a promising candidate drug, inexpensive, easy to administer, and simple to add to the routine management of deliveries in hospitals. This large, adequately powered, multicenter, randomized placebo-controlled trial seeks to determine if the risk-benefit ratio favors the routine use of TXA after delivery to prevent PPH. TRIAL REGISTRATION: ClinicalTrials.gov NCT02302456 (November 17, 2014).

Severity of post-partum hemorrhage after vaginal delivery is not predictable from clinical variables available at the time post-partum hemorrhage is diagnosed.

AIM: Identify women at risk of severe post-partum hemorrhage (PPH) by building a prediction model based on clinical variables available at PPH diagnosis. METHODS: We analyzed data on a cohort of 7236 women with PPH after vaginal delivery from 106 maternity units. Severe PPH was defined as the loss of more than 2000 mL of blood, peripartum drop in hemoglobin of 4 g/dL or more, transfusion of at least four packed red blood cells, embolization, hemostasis surgery, transfer to an intensive care unit or death. The Akaike criterion helped selecting the covariates of a multivariate logistic regression model. The performance of the model was studied through building a receiver-operator curve (ROC). The relative utility of the final model was used to determine the importance of the model in decision-making. RESULTS: Among all PPH, the prevalence of severe cases was 18.5%. Several clinical variables were significantly associated with severe PPH (e.g. parity, multiple pregnancy, labor induction, instrumental delivery). The multivariate prediction model was built. The area under the ROC for prediction of severe cases was 0.63 (95% confidence interval, 0.62-0.65). Nevertheless, the sensitivity and specificity of the prediction model were 0.49 and 0.70, respectively, for a threshold at 0.20 (near prevalence). The relative utility was 0.19 for a threshold near prevalence (20%). CONCLUSION: Because of important misclassifications, even the best model we could build with the available clinical data cannot be reasonably recommended for routine use. Every patient with PPH should receive most optimal management. Other types of information, possibly laboratory data, are probably needed.

Transfusion practices in postpartum hemorrhage: a population-based study.

OBJECTIVE: To describe transfusion practices and anemia in women with postpartum hemorrhage (PPH), according to the clinical context. DESIGN: Population-based cohort study. SETTING: A total of 106 French maternity units (146 781 deliveries, December 2004 to November 2006). POPULATION: All women with PPH (n = 9365). METHODS: Description of the rate of red blood cell (RBC) transfusion in PPH overall and compared with transfusion guidelines. MAIN OUTCOME MEASURES: Transfusion practices and postpartum anemia by mode of delivery and cause of PPH in women given RBCs within 12 h after PPH. RESULTS: A total of 701 women received RBCs (0.48 ± 0.04% of all women and 7.5 ± 0.5% of women with PPH). Half the women with clinical PPH and hemoglobin lower than 7.0 g/dL received no RBCs. In the group with clinical PPH and transfusion within 12 h (n = 426), operative vaginal delivery was associated with a larger maximal hemoglobin drop, more frequent administration of fresh-frozen plasma (FFP) and pro-hemostatic agents [odds ratio (OR) 3.54, 95% confidence interval (95% CI) 1.12-11.18], transfusion of larger volumes of RBCs and FFP, a higher rate of massive RBCs transfusion (OR 5.22, 95% CI 2.12-12.82), and more frequent use of conservative surgery (OR 3.2, 95% CI 1.34-7.76), compared with spontaneous vaginal delivery. CONCLUSIONS: The RBC transfusion for PPH was not given in a large proportion of women with very low hemoglobin levels despite guidelines to the contrary. Operative vaginal delivery is characterized by higher blood loss and more transfusions than spontaneous vaginal delivery.