Posttraumatic stress disorder 2 months after cesarean delivery: a multicenter prospective study.

BACKGROUND: The prevalence and risk factors of posttraumatic stress disorder after cesarean delivery, outside high-risk contexts, remain unclear. OBJECTIVE: This study aimed to assess posttraumatic stress disorder prevalence and risk factors at 2 months postpartum among a general population of women with cesarean delivery. STUDY DESIGN: This was a prospective ancillary cohort study of the Tranexamic Acid for Preventing Postpartum Hemorrhage after Cesarean Delivery (TRAAP2) trial, conducted in 27 French hospitals from 2018 to 2020, enrolling women expected to undergo cesarean delivery before or during labor at ≥34 weeks of gestation. After randomization, characteristics of the cesarean delivery and postpartum blood loss were prospectively collected. Two months after childbirth, posttraumatic stress disorder profile (presence of posttraumatic stress disorder symptoms) and provisional diagnosis (positive screening for diagnosis consistent with a posttraumatic stress disorder) were assessed by 2 self-administered questionnaires (Impact of Event Scale - Revised and Traumatic Event Scale). The corrected posttraumatic stress disorder prevalence was estimated with inverse probability weighting to take nonresponse into account. Associations between potential risk factors and posttraumatic stress disorder were analyzed by multivariate logistic or linear regression modeling according to the type of dependent variable. RESULTS: In total, 2785 of 4431 women returned the Impact of Event Scale - Revised questionnaire and 2792 the Traumatic Event Scale (response rates of 62.9% and 63.0%). The prevalence of posttraumatic stress disorder profile was 9.0% (95% confidence interval, 7.8%-10.3%) and of provisional diagnosis 1.7% (95% confidence interval, 1.2%-2.4%). Characteristics associated with a higher risk of posttraumatic stress disorder profile were prepregnancy vulnerability factors (young age, high body mass index, and African-born migrant) and cesarean delivery-related obstetrical factors (cesarean delivery after induced labor [adjusted odds ratio, 1.81; 95% confidence interval, 1.14-2.87], postpartum hemorrhage [adjusted odds ratio, 1.61; 95% confidence interval, 1.04-2.46] and high-intensity pain during the postpartum stay [adjusted odds ratio, 1.90; 95% confidence interval, 1.17-3.11]). Women who had immediate skin-to-skin contact with their newborn were at lower risk of posttraumatic stress disorder (adjusted odds ratio, 0.66; 95% confidence interval, 0.46-0.98), and women with bad memories of delivery on day 2 postpartum were at higher risk (adjusted odds ratio, 3.20; 95% confidence interval, 1.97-5.12). The Impact of Event Scale - Revised and the Traumatic Event Scale yielded consistent results. CONCLUSION: Approximately 1 in 11 women with cesarean deliveries had posttraumatic stress disorder symptoms at 2 months postpartum. Some obstetrical interventions and components of cesarean delivery management may influence this risk.

Prevalence and risk factors for postpartum depression 2 months after a vaginal delivery: a prospective multicenter study.

BACKGROUND: Very little is known about the prevalence and risk factors of postpartum depression among women with vaginal births without major pregnancy complications. OBJECTIVE: This study aimed to assess the prevalence of postpartum depression and identify its characteristics 2 months after singleton vaginal delivery at or near term. STUDY DESIGN: This was an ancillary cohort study of the TRanexamic Acid for Preventing Postpartum Hemorrhage After Vaginal Delivery randomized controlled trial, which was conducted in 15 French hospitals in 2015-2016 and enrolled women with singleton vaginal deliveries after 35 weeks of gestation. After randomization, the characteristics of labor, delivery, and the immediate postpartum experience, including the experience of childbirth, were prospectively collected. Medical records provided women's other characteristics, particularly any psychiatric history. Of note, 2 months after childbirth, provisional postpartum depression diagnosis was defined as a score of ≥13 on the Edinburgh Postnatal Depression Scale, a validated self-administered questionnaire. The corrected prevalence of postpartum depression was calculated with the inverse probability weighting method to take nonrespondents into account. Associations between potential risk factors and postpartum depression were analyzed by multivariate logistic regression. Moreover, an Edinburgh Postnatal Depression Scale cutoff value of ≥11 was selected to perform a sensitivity analysis. RESULTS: The questionnaire was returned by 2811 of 3891 women (72.2% response rate). The prevalence rates of the provisional diagnosis were 9.9% (95% confidence interval, 8.6%-11.3%) defined by an Edinburgh Postnatal Depression Scale score of ≥13 and 15.5% (95% confidence interval, 14.0%-17.1%) with a cutoff value of ≥11. The characteristics associated with higher risks of postpartum depression in multivariate analysis were mostly related to prepregnancy characteristics, specifically age of <25 years (adjusted odds ratio, 1.8; 95% confidence interval, 1.1-2.9) and advanced age (adjusted odds ratio, 1.8; 95% confidence interval, 1.2-2.6), migration from North Africa (adjusted odds ratio, 2.9; 95% confidence interval, 1.9-4.4), previous abortion (adjusted odds ratio, 1.4; 95% confidence interval, 1.0-2.0), and psychiatric history (adjusted odds ratio, 2.9; 95% confidence interval, 1.8-4.8). Some characteristics of labor and delivery, such as induced labor (adjusted odds ratio, 1.5; 95% confidence interval, 1.1-2.0) and operative vaginal delivery (adjusted odds ratio, 1.4; 95% confidence interval, 1.0-2.0), seemed to be associated with postpartum depression. In addition, bad memories of childbirth in the immediate postpartum were strongly associated with postpartum depression symptoms at 2 months after giving birth (adjusted odds ratio, 2.4; 95% confidence interval, 1.3-4.2). CONCLUSION: Approximately 10% of women with vaginal deliveries have postpartum depression symptoms, assessed by a score of ≥13 on the depression scale that was used at 2 months. Prepregnancy vulnerability factors; obstetrical characteristics, such as induced labor and operative vaginal delivery; and bad memories of childbirth 2 days after delivery were the main factors associated with this provisional diagnosis. A screening approach that targets risk factors may help to identify women at risk of postpartum depression who could benefit from early intervention.

Shock index as a predictor of postpartum haemorrhage after vaginal delivery: Secondary analysis of a multicentre randomised controlled trial.

OBJECTIVE: To describe the shock index (SI) distribution during the first 2 hours after delivery and to evaluate its performance when measured 15 and 30 minutes after delivery for predicting postpartum haemorrhage (PPH) occurrence in the general population of parturients after vaginal delivery. DESIGN: Secondary analysis of a multicentre randomised controlled trial testing prophylactic administration of tranexamic acid versus placebo in addition to prophylactic oxytocin to prevent PPH. SETTING: 15 French maternity units in 2015-2016. SAMPLE: 3891 women with a singleton live fetus ≥35 weeks, born vaginally. METHODS: For each PPH-related predicted outcome, we calculated the area under the receiver operating characteristic curve (AUROC) values of the SI at 15 and 30 minutes after delivery and its predictive performance for SI cut-off values of 0.7, 0.9 and 1.1. MAIN OUTCOME MEASURES: Quantitative blood loss ≥1000 ml (QBL ≥1000 ml) measured in a graduated collector bag and provider-assessed clinically significant PPH (cPPH). RESULTS: Prevalence of QBL ≥1000 ml and cPPH was respectively 2.7% (104/3839) and 9.1% (354/3891). The distributions of the SI at 15 and 30 minutes after delivery were similar with a median value of 0.73 and 97th percentile of 1.11 for both. The AUROC values of the 15-minute SI for discriminating QBL ≥1000 ml and cPPH were respectively 0.66 (lower limit of the 95% confidence interval [LCI] 0.60) and 0.56 (LCI 0.52); and for the 30-minute SI 0.68 (LCI 0.61) and 0.49 (LCI 0.43). CONCLUSIONS: The shock index at 15 and 30 minutes after delivery did not satisfactorily predict either QBL ≥1000 ml or clinical PPH.

The ethics of induction of labor at 39 weeks in low-risk nulliparas in research and clinical practice.

The "A Randomized Trial of Induction Versus Expectant Management" trial (ARRIVE trial) published in 2018 suggested that induction of labor can be considered a "reasonable option" for low-risk nulliparous women at ≥39 weeks of gestation. The study results led some professional societies to endorse the option for elective induction of labor at 39 weeks of gestation in low-risk nulliparas, and this has begun to change obstetrical practice. The ARRIVE trial provided valuable information supporting the benefits of induction of labor; however, the trial is insufficient to serve as the primary justification for widespread elective induction of labor at 39 weeks of gestation in low-risk nulliparas because of concerns about external validity. Thus, the French ARRIVE trial was designed to test the hypothesis in a different setting that elective induction of labor at 39 weeks of gestation in low-risk nulliparas leads to a lower cesarean delivery rate than expectant management. This ongoing trial has been criticized as "pseudoscientific" and telling "women where, when, and how to give birth." We reject these allegations and extensively examine the ethical framework that should govern clinical and research interventions, including elective induction of labor at 39 weeks of gestation in low-risk nulliparas. This study aimed to discuss the ethical issues that emerge from randomized trials of elective induction of labor at 39 weeks of gestation in low-risk nulliparas and the ethics of the clinical practice itself. The analysis of existing evidence shows the importance of further research on induction of labor at 39 weeks of gestation in low-risk women. Certain aspects of research ethics in this area, particularly the consent of pregnant women in a context where autonomy remains fragile, call for vigilance. In addition, we emphasize that childbirth is not only a medical object but also a social phenomenon that cannot be regarded only from the perspective of a health risk to be managed by clinical research. Further research on this issue is needed to allow pregnant women to make informed decisions, and the results should be integrated with social issues. The perspective of women is required in constructing, evaluating, and implementing medical interventions in childbirth, such as induction of labor at 39 weeks of gestation.

Closed- or open-glottis pushing for vaginal delivery: a planned secondary analysis of the TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery study.

BACKGROUND: The effect on obstetrical outcomes of closed- or open-glottis pushing is uncertain among both nulliparous and parous women. OBJECTIVE: This study aimed to assess the association between open- or closed-glottis pushing and mode of delivery after an attempted singleton vaginal birth at or near term. STUDY DESIGN: This was an ancillary planned cohort study of the TRAAP (TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery) randomized controlled trial, conducted in 15 French maternity units from 2015 to 2016 that enrolled women with an attempted singleton vaginal delivery after 35 weeks' gestation. After randomization, characteristics of labor and delivery were prospectively collected, with special attention to active second-stage pushing and a specific planned questionnaire completed immediately after birth by the attending care provider. The exposure was the mode of pushing, classified into 2 groups: closed- or open-glottis. The main endpoint was operative vaginal delivery. Secondary endpoints were items of maternal morbidity, including severe perineal laceration, episiotomy, postpartum hemorrhage, duration of the second stage of labor, and a composite severe neonatal morbidity outcome. We also assessed immediate maternal satisfaction, experience of delivery, and psychological status 2 months after delivery. The associations between mode of pushing and outcome were analyzed by multivariate logistic regression to control for confounding bias, with multilevel mixed-effects analysis, and a random intercept for center. RESULTS: Among 3041 women included in our main analysis, 2463 (81.0%) used closed-glottis pushing and 578 (19.0%) open-glottis pushing; their respective operative vaginal delivery rates were 19.1% (n=471; 95% confidence interval, 17.6-20.7) and 12.5% (n=72; 95% confidence interval, 9.9-15.4; P<.001). In an analysis stratified according to parity and after controlling for available confounders, the rate of operative vaginal delivery did not differ between the groups among nulliparous women: 28.7% (n=399) for the closed-glottis and 27.5% (n=64) for the open-glottis group (adjusted odds ratio, 0.93; 95% confidence interval, 0.65-1.33; P=.7). The operative vaginal delivery rate was significantly lower for women using open- compared with closed-glottis pushing in the parous population: 2.3% (n=8) for the open- and 6.7% (n=72) for the closed-glottis groups (adjusted odds ratio, 0.43; 95% confidence interval, 0.19-0.90; P=.03). Other maternal and neonatal outcomes did not differ between the 2 modes of pushing among either the nulliparous or parous groups. CONCLUSION: Among nulliparous women with singleton pregnancies at term, the risk of operative vaginal birth did not differ according to mode of pushing. These results will inform shared decision-making about the mode of pushing during the second stage of labor.

Tranexamic acid for reduction of blood loss after Caesarean delivery: a cost-effectiveness analysis of the TRAAP2 trial.

BACKGROUND: Prophylactic administration of tranexamic acid is associated with a reduction of blood loss after Caesarean delivery, but cost-effectiveness for this indication has not been assessed. METHODS: We used data from the TRAAP2 trial, a multicentre, double-blinded, RCT aimed at estimating the efficacy of tranexamic acid for preventing postpartum haemorrhage among women undergoing Caesarean delivery. Women recruited at 27 French maternity hospitals from 2018 to 2020 were enrolled before the procedure if they had a Caesarean delivery before or during labour at 34 or more weeks of gestation. The main outcomes were the cost of hospital stay for delivery and the incremental cost per delivery without complication within 90 days after delivery with tranexamic acid compared with placebo. Differences in costs and the incremental net monetary benefit (INMB) were estimated using linear regression models, and the cost-effectiveness probability of tranexamic acid compared with placebo was estimated through the parametric distribution of the INMB. RESULTS: The proportion of women without complications at day 90 was 70.7% in the tranexamic acid group and 66.0% in the placebo group. Mean total costs until occurrence of a complication of interest were €3321 in the tranexamic acid group and €3260 in the placebo group, resulting in a difference between the two groups of 7.2% and €55 after multiple imputation. The adjusted incremental cost-effectiveness ratio was €762 per additional Caesarean delivery without a complication at 90 days after delivery. At a cost-effectiveness threshold of €10,000, the cost-effectiveness probability of tranexamic acid compared with placebo was 99.9%, varying from 5.8% to 100.0% for thresholds from €0 to €10,000 per additional delivery without a complication at day 90. CONCLUSION: Tranexamic acid for the prevention of blood loss is cost-effective in reducing complications after Caesarean delivery at day 90 postpartum. However, the effect size (in cost and effectiveness) is very low. CLINICAL TRIAL REGISTRATION: NCT03431805.

Comparison of quantitative and calculated postpartum blood loss after vaginal delivery.

BACKGROUND: Because there is no consensus on the method of assessing postpartum blood loss, the comparability and relevance of the postpartum hemorrhage-related literature are questionable. Quantitative blood loss assessment using a volumetric technique with a graduated collector bag has been proposed to overcome limitations of intervention-based outcomes but remains partly subjective and potentially biased by amniotic fluid or missed out-of-bag losses. Calculated blood loss based on laboratory parameters has been studied and used as an objective method expected to reflect total blood loss. However, few studies have compared quantitative with calculated blood loss. OBJECTIVE: This study aimed to compare the distribution of postpartum blood loss after vaginal delivery assessed by 2 methods-quantitative and calculated blood loss-and the incidence of abnormal blood loss with each method. STUDY DESIGN: Data were obtained from the merged database of 3 multicenter, randomized controlled trials, all testing different interventions to prevent postpartum blood loss in individuals with a singleton live fetus at ≥35 weeks of gestation, born vaginally. All 3 trials measured blood loss volume by using a graduated collector bag. Hematocrit was measured in the eighth or ninth month of gestation and on day 2 postpartum. The 2 primary outcomes were: quantitative blood loss, defined by the total volume of blood loss measured in a graduated collector bag, and calculated blood loss, mathematically defined from the peripartum hematocrit change (estimated blood volume × [(antepartum hematocrit-postpartum hematocrit)/antepartum hematocrit], where estimated blood volume [mL]=booking weight [kg] × 85). We modeled the association between positive quantitative blood loss and positive calculated blood loss with polynomial regression and calculated the Spearman correlation coefficient. RESULTS: Among the 8341 individuals included in this analysis, the median quantitative blood loss (100 mL; interquartile range, 50-275) was significantly lower than the median calculated blood loss (260 mL; interquartile range, 0-630) (P<.05). The incidence of abnormal blood loss was lower with quantitative blood loss than calculated blood loss for all 3 thresholds: for ≥500 mL, it was 9.6% (799/8341) and 32.3% (2691/8341), respectively; for ≥1000 mL, 2.1% (176/8341) and 11.5% (959/8341); and for ≥2000 mL, 0.1% (10/8341) and 1.4% (117/8341) (P<.05). Quantitative blood loss and calculated blood loss were significantly but moderately correlated (Spearman coefficient=0.44; P<.05). The association between them was not linear, and their difference tended to increase with blood loss. Negative calculated blood loss values occurred in 23% (1958/8341) of individuals; among them, >99% (1939/1958) had quantitative blood loss ≤500 mL. CONCLUSION: Quantitative and calculated blood loss were significantly but moderately correlated after vaginal delivery. However, clinicians should be aware that quantitative blood loss is lower than calculated blood loss, with a difference that tended to rise as blood loss increased.

Predictors of shoulder dystocia at the time of operative vaginal delivery: a prospective cohort study.

Our aim was to identify factors associated with shoulder dystocia following an attempted operative vaginal delivery (aOVD) in a prospective cohort study and to evaluate whether these factors can be used to accurately predict shoulder dystocia by building a score of shoulder dystocia risk. This was a planned secondary analysis of a prospective cohort study of deliveries with aOVD at term from 2008-2013. Cases were defined as women with shoulder dystocia following an aOVD defined as a delivery that requires additional obstetric maneuvers following failure of gentle downward traction on the fetal head to effect delivery of the shoulders. Multivariate logistic regression analyses were performed to determine risk factors for shoulder dystocia. Shoulder dystocia occurred in 57 (2.7%) of the 2118 women included. In the whole cohort, women with shoulder dystocia more often had a history of shoulder dystocia (3.5% vs. 0.2%, p = 0.01), and there was a significant interaction between aOVD and gestational age and the duration of the second stage of labor: women with shoulder dystocia more often had a gestational age > 40 weeks and a second stage of labor longer than 3 h specifically for midpelvic aOVD. In multivariable analysis, a history of shoulder dystocia was the only factor independently associated with shoulder dystocia following aOVD (aOR 27.00, 95% CI 4.10-178.00). The AUC for the receiver operating characteristic curve generated using a multivariate model with term interaction with head station was 0.70 (95% CI 0.62-0.77). The model failed to accurately predict shoulder dystocia.

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.

Guidelines for the management of urgent obstetric situations in emergency medicine, 2022.

OBJECTIVE: To provide recommendations on the management of urgent obstetrical emergencies outside the maternity ward. DESIGN: A group of 24 experts from the French Society of Emergency Medicine (SFMU), the French Society of Anaesthesia and Intensive Care Medicine (SFAR) and the French College of Gynaecologists and Obstetricians (CNGOF) was convened. Potential conflicts of interest were formally declared at the outset of the guideline development process, which was conducted independently of industry funding. The authors followed the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method to assess the level of evidence in the literature. The potential drawbacks of strong recommendations in the presence of low-level evidence were highlighted. Some recommendations with an insufficient level of evidence were not graded. METHODS: Eight areas were defined: imminent delivery, postpartum haemorrhage (prevention and management), threat of premature delivery, hypertensive disorders in pregnancy, trauma, imaging, cardiopulmonary arrest, and emergency obstetric training. For each field, the expert panel formulated questions according to the PICO model (population, intervention, comparison, outcomes) and an extensive literature search was conducted. Analysis of the literature and formulation of recommendations were conducted according to the GRADE method. RESULTS: Fifteen recommendations on the management of obstetrical emergencies were issued by the SFMU/SFAR/CNGOF panel of experts, and 4 recommendations from formalised expert recommendations (RFE) established by the same societies were taken up to answer 4 PICO questions dealing with the pre-hospital context. After two rounds of voting and several amendments, strong agreement was reached for all the recommendations. For two questions (cardiopulmonary arrest and inter-hospital transfer), no recommendation could be made. CONCLUSIONS: There was significant agreement among the experts on strong recommendations to improve practice in the management of urgent obstetric complications in emergency medicine.

Trial of Labor Compared With Elective Cesarean Delivery for Low-Lying Placenta.

OBJECTIVE: To compare outcomes of women with low-lying placenta by planned mode of delivery and distance from the internal os distance. METHODS: Six tertiary maternity hospitals in France participated in this retrospective multicenter study of births from 2007-2012. Women with low-lying placenta , defined as an internal os distance of 20 mm or less, who gave birth after 35 weeks of gestation were included and classified in the planned trial-of-labor or elective cesarean delivery groups. The primary endpoint was severe postpartum hemorrhage (PPH) defined as blood loss exceeding 1,000 mL. Secondary outcomes were composite variables of severe maternal and neonatal morbidity. We used multivariable logistic regression and propensity scores to compare outcomes by planned mode of delivery. RESULTS: Among 128,233 births during the study period, 171 (0.13%) women had low-lying placenta: 70 (40.9%) in the trial-of-labor group and 101 (59.1%) who underwent elective cesarean delivery. The rate of severe PPH was 22.9% (16/70, 95% CI 13.7-34.4) for the trial-of-labor group and 23.0% (23/101, 95% CI 15.2-32.5) for the cesarean delivery group ( P =.9); severe maternal and neonatal morbidity rates were likewise similar (2.9% vs 2.0% [ P =.7] and 12.9% vs 9.9% [ P =.5], respectively). Trial-of-labor was not significantly associated with a higher rate of severe PPH after multivariable logistic regression and propensity score-weighted analysis (adjusted odds ratio [aOR] 1.42, 95% CI 0.62-3.24 [ P =.4]; and aOR 1.34, 95% CI 0.53-3.38 [ P =.5], respectively). The vaginal delivery rate in the trial-of-labor group was 50.0% (19/38) in those with an internal os distance of 11-20 mm and 18.5% (5/27) in those with a distance of 1-10 mm. CONCLUSION: Our results support a policy of offering a trial of labor to women with low-lying placenta after 35 weeks of gestation and an internal os distance of 11-20 mm. An internal os distance of 1-10 mm reduces the likelihood of vaginal birth considerably, compared with 11-20 mm, but without increasing the incidence of severe PPH or severe maternal morbidity.

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.

Maternal and Neonatal Morbidity After Attempted Operative Vaginal Delivery.

OBJECTIVE: To assess severe short-term maternal and neonatal morbidity and pelvic floor disorders at 6 months postpartum after attempted operative vaginal delivery according to the instrument used. METHODS: We conducted a prospective study of women with live, singleton, term fetuses in vertex presentation. Patients attempted operative vaginal delivery in a French tertiary care university hospital from December 2008 through October 2013. We used multivariable logistic regression and propensity score methods to control for indication bias and compare outcomes associated with vacuum-assisted or forceps- or spatula-assisted delivery. Severe maternal and neonatal morbidity were composite primary endpoints. Symptoms of urinary incontinence (UI) and anal incontinence (AI) were assessed 6 months after delivery by validated self-administered questionnaires. RESULTS: Among 2,128 attempted operative vaginal deliveries, 30.7% (n=654) used vacuum and 69.3% (n=1,474) used forceps or spatulas. Severe maternal morbidity occurred in 5.4% (n=35; 95% CI 3.8-7.4) of vacuum attempts and 10.5% (n=154; 95% CI 8.3-12.1) of forceps or spatula attempts (P<.001); severe neonatal morbidity occurred in 8.4% (n=55; 95% CI 6.4-10.8) and 10.2% (n=155; 95% CI 8.7-11.8), respectively (P=.2). Although attempted operative vaginal deliveries with forceps or spatula were significantly associated with more frequent severe maternal morbidity (adjusted odds ratio [aOR] 1.99 95% CI 1.27-3.10) in the multivariable logistic regression analysis, this association was no longer significant after propensity score matching (aOR 1.46 95% CI 0.72-2.95). Attempted operative vaginal deliveries with forceps or spatula were not significantly associated with more frequent severe neonatal morbidity after multivariable logistic regression or propensity score matching. Among the 934 women (43.9%) who responded to questionnaires at 6 months, the prevalence of symptoms of UI and AI were 22.7% and 22.0%, respectively, with no significant differences between the groups. CONCLUSION: In singleton term pregnancies, neither severe short-term maternal or neonatal morbidity nor UI or AI were more frequent after attempted operative vaginal delivery by forceps or spatulas than by vacuum after controlling for indication bias with a propensity score analysis.

Uterine-sparing surgical procedures to control postpartum hemorrhage.

Postpartum hemorrhage remains one of the principal causes of maternal mortality in the United States and throughout the world. Its management, which must be multidisciplinary (obstetrics, midwifery, anesthesiology, interventional radiology, and nursing), depends on the speed of both diagnosis and implementation of medical and surgical treatment to control the hemorrhage. The aim of this work is to describe the various techniques of vessel ligation and of uterine compression for controlling and treating severe hemorrhage, and to present the advantages and disadvantages of each. It is not difficult to perform vessel ligation of the uterine arteries: O'Leary's bilateral ligation of the uterine artery, Tsirulnikov's triple ligation, and AbdRabbo's stepwise uterine devascularization (that is, stepwise triple ligation). These procedures are associated with a high success rate (approximately 90%) and a low complication rate. Bilateral ligation of the internal iliac (hypogastric) arteries is more difficult to perform and potentially less effective (approximately 70% effectiveness) than the previously mentioned procedures. Its complication rate is low, but the complications are most often serious. There is no evidence that future fertility or subsequent obstetrical outcomes are impaired by ligation of either the uterine or internal iliac arteries. There are many techniques used for uterine compression sutures, and none has shown clear superiority to another. Uterine compression suture has an effectiveness rate of approximately 75% after failure of medical treatment and approximately 80% as a second-line procedure after unsuccessful vessel ligation. The risk of synechiae after uterine compression suture has not yet been adequately evaluated, but is probably around 5%. The risk of synechiae after uterine compression suture has not yet been adequately evaluated, but probably ranges between 5% and 10%. The methodologic quality of the studies assessing uterine-sparing surgical procedures remains limited, with no comparative studies. Accordingly, no evidence suggests that any one of these methods is better than any other. Accordingly, the choice of surgical technique to control hemorrhage must be guided firstly by the operator's experience. If the hemorrhage continues after a first-line uterine-sparing surgical procedure and the patient remains hemodynamically stable, a second-line procedure can be chosen. Nonetheless, the application of these procedures must not delay the performance of a peripartum hysterectomy in cases of hemodynamic instability.

Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery.

BACKGROUND: Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS: In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS: Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS: Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).