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Objective: To evaluate the prevalence and risk factors of maternal dissatisfaction 2 days after a singleton vaginal delivery at or near term., Methods: We conducted a planned ancillary cohort study of the TRanexamic Acid for Preventing Postpartum Hemorrhage After Vaginal Delivery (TRAAP) randomized controlled trial. Maternal dissatisfaction, related to the birth and to the subsequent hospital stay, was assessed 2 days postpartum by two self-administered questions: "Are you satisfied with the care you received during your child's birth?" and "Are you satisfied with the care you have received during your hospital stay?". Satisfaction was defined by answers of "extremely satisfied" or "very satisfied," and dissatisfaction by the responses "moderately satisfied," "not very satisfied," or "not at all satisfied". Their association with maternal dissatisfaction was analyzed by random-effects logistic regression., Results: The prevalence of maternal dissatisfaction with the birth was 2.9%, and with the hospital stay 9.5%. Characteristics associated with a higher risk of maternal dissatisfaction with the birth were labor exceeding 6 h, bad memories of the birth and, only for women without complicated deliveries, manual examination of the uterine cavity. The only characteristic associated with a higher risk of dissatisfaction with the hospital stay was non-French nationality. None of the postpartum hemorrhage, third- or fourth-degree perineal lacerations, operative vaginal delivery, episiotomy and uterine massage were associated with a higher risk of maternal dissatisfaction., Conclusion: Maternal dissatisfaction was low after singleton vaginal deliveries at or near term. Strategies aiming to avoid labor longer than 6 h and manual examination of the uterine cavity may decrease maternal dissatisfaction after delivery., (© 2024 The Author(s). International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Fetal death is defined as the spontaneous cessation of cardiac activity after 14 weeks gestational age (GA). Regarding prevention of fetal death in the general population, it is not recommended to counsel or prescribe rest, aspirin, vitamin A, vitamin D, or micronutrient supplementation; systematically look for nuchal cord during prenatal screening ultrasound; or perform systematic antepartum monitoring by cardiotocography for the sole purpose of reducing the risk of fetal death. It is recommended to offer vaccination against influenza in epidemic periods and against SARS-CoV-2. Regarding evaluation in the event of fetal death, it is recommended that a fetal autopsy and anatomopathologic examination of the placenta be performed; chromosomal analysis be performed by microarray testing, rather than by conventional karyotype (with postnatal sampling of the fetal placental surface preferred for genetic purposes); testing for antiphospholipid antibodies be performed, with systematic Kleihauer-Betke testing and for irregular agglutinins; and summary consultation to discuss these examination results be offered. Regarding announcement and support, it is recommended that fetal death be announced without ambiguity, using simple words adapted to each situation, after which the couple should be supported with empathy across the different stages of their care. Regarding patient management in cases of fetal death, it is recommended that: in the absence of risks for disseminated intravascular coagulation or maternal demise, the patient's wishes regarding the timing between the fetal death diagnosis and labor induction should be considered; return home is possible, according to the patient's wishes; in all situations except maternal life-threatening emergencies, the preferred mode of delivery is vaginal, regardless of previous cesarean section(s); mifepristone 200 mg be prescribed at least 24 h before induction; and perimedullary analgesia be initiated at the start of induction if requested by the patient, regardless of GA. Of note, there is insufficient evidence to recommend either the administration route (i.e., vaginal or oral) of misoprostol or prostaglandin type. Regarding the risk of recurrence after unexplained fetal death: the incidence does not appear to be increased in subsequent pregnancies; in cases with a history of fetal death due to vascular problems, low-dose aspirin is recommended to reduce perinatal morbidity (otherwise, evidence is insufficient to recommend the prescription of aspirin); no optimal delay in initiating another pregnancy should be recommended based solely on a history of fetal death; fetal heart rate monitoring is not indicated based solely on a history of fetal death; although systematic labor induction is not recommended, induction may be considered depending on the context and parental request, and considering fetal age, benefits, and risks, especially before 39 weeks GA. Note that if the cause of fetal death is identified, management should be adjusted on a case-by-case basis. Regarding fetal death in a twin pregnancy, it is recommended that the surviving twin be examined immediately upon fetal death diagnosis; in a dichorionic twin pregnancy, preterm delivery induction is not recommended; in a monochorionic twin pregnancy, the surviving twin should be immediately evaluated for signs of acute fetal anemia, with weekly ultrasound monitoring for the first month, though immediate labor induction is not recommended., (© 2024 The Author(s). International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Objectives: There have been significant advances in the medical management of severe postpartum hemorrhage (sPPH) over recent decades, which is reflected in numerous published guidelines. To date, many of the currently available national and international guidelines recommend recombinant factor VIIa (rFVIIa) to be used only at a very late stage in the course of sPPH, as a "last resort", before or after hysterectomy. Based on new safety data, rFVIIa has recently been approved by the European Medicines Agency (EMA) and Swissmedic for use in sPPH, if uterotonics are insufficient to achieve hemostasis, which in fact is significantly earlier in the course of postpartum hemorrhage (PPH). We therefore aimed to develop expert consensus guidance as a step toward standardizing care with the use of rFVIIa for clinicians managing women experiencing life-threatening sPPH., Methods: The consensus process consisted of one face-to-face meeting with a group of nine experts, including eight obstetrician-gynecologists and a hematologist highly experienced in sPPH care in tertiary care perinatal centers. The panel was representative of multidisciplinary expertise in the European obstetrics community and provided consensus opinion in answer to pre-defined questions around clinical practice with rFVIIa in the management of sPPH. Recommendations have been based on current national and international guidelines, extensive clinical experience, and consensus opinion, as well as the availability of efficacy and new safety data., Results: The expert panel developed 17 consensus statements in response to the 13 pre-defined questions on the use of rFVIIa in the management of sPPH including: available efficacy and safety data and the need for interdisciplinary expertise between obstetricians, anesthesiologists, and hematologists in the management of sPPH. Based on novel data, the experts recommend: (1) earlier administration of rFVIIa in patients with sPPH who do not respond to uterotonic administration to optimize the efficacy of rFVIIa; (2) the importance of hematological parameter prerequisites prior to the administration of rFVIIa to maximize efficacy; and (3) continued evaluation or initiation of further invasive procedures according to standard practice. Furthermore, recommendations on the timing of rFVIIa treatment within the sPPH management algorithm are outlined in a range of specified clinical scenarios and settings, including vaginal delivery, cesarean section, and smaller birthing units before transfer to a tertiary care center. The panel agreed that according to available, and new data, as well as real-world experience, there is no evidence that the use of rFVIIa in patients with sPPH increases the risk of thromboembolism. The authors acknowledge that there is still limited clinical effectiveness data, as well as pharmacoeconomic data, on the use of rFVIIa in sPPH, and recommend further clinical trials and efficacy investigation., Conclusions: This expert panel provides consensus guidance based on recently available data, clinical experience, and expert opinion, augmented by the recent approval of rFVIIa for use in sPPH by the EMA. These consensus statements are intended to support clinical care for sPPH and may help to provide the impetus and a starting point for updates to existing clinical practice guidelines.

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., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The prevalence and risk factors of postpartum depression after cesarean delivery remain unclear., Objective: To assess the prevalence of postpartum depression and its risk factors 2 months after cesarean delivery., Study Design: Prospective ancillary cohort study of the Tranexamic Acid for Preventing Postpartum Hemorrhage after Cesarean Delivery trial, conducted in 27 French hospitals in 2018 to 2020 and enrolling women undergoing cesarean delivery before or during labor at 34 or more weeks of gestation. After randomization, characteristics of the cesarean delivery, postpartum blood loss, and immediate postpartum period, including memories of delivery and postoperative pain, were prospectively collected. Women's characteristics, particularly any psychiatric history, were collected from medical records. Two months after childbirth, a postpartum depression provisional diagnosis was defined as a score of 13 or higher 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. Multivariate logistic regression analyzed associations between potential risk factors and postpartum depression. A sensitivity analysis used an Edinburgh Postnatal Depression Scale cutoff value of 11 or higher., Results: The questionnaire was returned by 2793/4431 women (63.0% response rate). The corrected prevalence of postpartum depression provisional diagnosis was 16.4% (95% confidence interval, 14.9%-18.0%) with an Edinburgh Postnatal Depression Scale score of 13 or higher and 23.1% (95% confidence interval, 21.4%-24.9%) with a cutoff value of 11 or higher. Characteristics associated with a higher risk of postpartum depression were prepregnancy characteristics such as young age (adjusted odds ratio 0.83, 95% confidence interval 0.74-0.93 for each 5-year increase in maternal age) and non-European country of birth (adjusted odds ratio 2.58, 95% confidence interval 1.85-3.59 for North Africa; adjusted odds ratio 1.57, 95% confidence interval 1.09-2.26 for Sub-Saharan Africa and adjusted odds ratio 1.99, 95% confidence interval 1.28-3.10 for other country of birth; reference: Europe) and some aspects of the cesarean delivery, notably its timing and context, emergency before labor (adjusted odds ratio 1.70, 95% confidence interval 1.15-2.50; reference: before labor without emergency) and during labor after induction of labor (adjusted odds ratio 1.36, 95% confidence interval 1.03-1.84; reference: before labor without emergency). Also at higher risk were women reporting high intensity pain during the postpartum stay (adjusted odds ratio 1.73, 95% confidence interval 1.32-2.26) and bad memories of delivery on day 2 postpartum (adjusted odds ratio 1.67, 95% confidence interval 1.14-2.45). Conversely, women who had social support in the operating room had a lower risk of postpartum depression (adjusted odds ratio 0.73, 95% confidence interval 0.53-0.97)., Conclusion: Around one woman in 6 had postpartum depression symptoms 2 months after cesarean delivery. Some cesarean-related obstetric factors may increase this risk: cesareans before labor for emergency situations or during labor after medically indicated induction of labor, severe postoperative pain, and bad memories of delivery before discharge. Specific subgroups of at-risk women could benefit from early screening or intervention to reduce the onset of postpartum depression. Perinatal professionals should pay particular attention to postoperative pain management., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Tranexamic acid is a recommended treatment for women with a clinical diagnosis of postpartum haemorrhage, but whether it can prevent bleeding is unclear. We conducted a systematic review and individual patient data (IPD) meta-analysis of randomised controlled trials to assess the effects of tranexamic acid in women giving birth., Methods: In this systematic review and IPD meta-analysis, we searched the WHO International Clinical Trials Registry Platform from database inception to Aug 4, 2024 for randomised trials that assessed the effects of tranexamic acid in women giving birth. Trials were eligible if they were prospectively registered, placebo-controlled, included more than 500 women, and had a low risk of bias for random sequence generation and allocation concealment. IPD were requested from the trial investigators. The primary outcomes were the numbers of women with life-threatening bleeding and thromboembolic events. We used a one-stage model to analyse the data and explored whether the effect of tranexamic acid varied by the underlying risk of life-threatening bleeding, type of birth, presence of moderate or severe anaemia, or timing of administration (before or after a diagnosis of postpartum haemorrhage). This study is registered with PROSPERO, CRD42022345775., Findings: We analysed data on 54 404 women from five trials. We obtained IPD for 43 409 women from four trials and aggregate data on 10 995 women from one trial. All trials had a low risk of bias. Life-threatening bleeding occurred in 178 (0·65%) of 27 300 women in the tranexamic acid group versus 230 (0·85%) of 27 093 women in the placebo group (pooled odds ratio [OR] 0·77 [95% CI 0·63-0·93]; p=0·008). There was no evidence that the effect of tranexamic acid varied by the underlying risk of life-threatening bleeding, type of birth, presence of moderate or severe anaemia or timing of administration. No significant difference was identified between tranexamic acid and placebo groups with regard to thromboembolic events: 50 (0·2%) of 26 571 women in the tranexamic acid group had fatal or non-fatal thromboembolic events versus 52 (0·2%) of 26 373 women in the placebo group (pooled OR 0·96 [0·65-1·41]; p=0·82) with no significant heterogeneity identified in the subgroup analyses., Interpretation: Tranexamic acid reduces the risk of life-threatening postpartum bleeding. We found no evidence that tranexamic acid increases the risk of thrombosis. Although we do not recommend the use of tranexamic acid in all women giving birth, consideration should be given to its use before a diagnosis of postpartum haemorrhage in women at high risk of death., Funding: The Bill & Melinda Gates Foundation., Competing Interests: Declaration of interests IR and HS-S declare receipt of support from the National Institute for Health and Care Research, Wellcome, and the John Moulton Foundation for support of their other research activities into the effects of tranexamic acid. All payments were made to their employing institution (London School of Hygiene & Tropical Medicine). IR also declares an unpaid role as convenor of an ad-hoc group (The Joint Royal Colleges tranexamic acid in surgery implementation group) to increase the use of tranexamic acid in surgical patients as per National Institute for Health and Care Excellence guidance. LS reports receipt of payment or honoraria from Ferring Pharmaceuticals, Norgine, Bayer, Pfizer, GlaxoSmithKline, and Organon for lectures, presentations, speakers bureaus, manuscript writing, or educational events. HA declares receipt of support from the National Institute of Child Health and Human Development/National Institutes of Health for grant OPTIMUM OB-TXA: Optimal TIMing, route and dose of tranexamic acid prior to UMbilical cord clamp for postpartum haemorrhage prevention; consulting fees from Hemosonics, Coagulant Therapeutics, Hemosquid; and payment or honoraria from COR2ED for lectures, presentations, speakers bureaus, manuscript writing, or educational events. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2022 Elsevier Inc. All rights reserved.)

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., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

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., (Copyright © 2023 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: Cardiovascular disease (CVD) is a major cause of morbidity and mortality in people with type 1 diabetes (PWT1D). We assessed cardiovascular risk factors and pharmacologic treatment in a large Canadian cohort of PWT1D., Methods: This cross-sectional study used data from adult PWT1D in the BETTER registry (n=974). CVD risk factor status, diabetes complications, and treatments (used as proxy for blood pressure and dyslipidemia) were self-reported through online questionnaires. Objective data were available for a subgroup of PWT1D (23%, n=224)., Results: Participants were adults (43.9±14.8 years) with a diabetes duration of 23.3±15.2 years; 34.8% reported glycated hemoglobin (A1C) levels of ≤7%, 67.2% reported a very high cardiovascular risk, and 27.2% reported at least 3 CVD risk factors. Most participants received care for CVD in accordance with the Diabetes Canada Clinical Practice Guidelines (DC-CPG), with a median recommended pharmacologic treatment score of 75.0%. However, 3 subgroups of participants with lower adherence (<70%) to DC-CPG were identified: 1) those with microvascular complications and receiving a statin (60.8%, 208 of 342) or renin-angiotensin axis nephroprotective therapy (52.6%, 180 of 342); 2) those aged ≥40 years and receiving statin therapy (67.1%, 369 of 550); and 3) those aged ≥30 years with a diabetes duration of ≥15 years and receiving statin therapy (58.9%, 344 of 584). Among a subgroup of participants with recent laboratory results, only 24.5% of PWT1D (26 of 106) achieved both A1C and low-density lipoprotein cholesterol targets., Conclusions: Most PWT1D received recommended pharmacologic cardiovascular protection, but specific subgroups required special attention. Target achievement for key risk factors remains suboptimal., (Copyright © 2023 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.)

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.

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., (© 2023. The Author(s).)

Aims: Compare the self-reported prevalence of severe hypoglycemia (level-3-H) in people with type 1 diabetes (PWT1D) according to two wording of definition: by the International Hypoglycemia Study Group (IHSG) and an alternate simplified version developed by patient-partners (PP)., Methods: Cross-sectional study (PWT1D >  = 14 years) self-reporting risk factors, patient-year incidence and annual prevalence of level-3-H were defined according to either IHSG's wording (low sugar levels requiring help from another person, or use of glucagon, or hospitalization, or loss of consciousness) or with an alternative simpler wording developed by PP (low sugar levels that you would have been unable to treat)., Results: Among 1430 eligible participants, in the last 12 months, the annual prevalence of level-3-H (IHSG: 242/100 vs. PP: 231/100 patient-years, p = 0.229) and median number of episodes (IHSG: 2.0 [1-3] vs. PP: 1.0 [1-3], p = 0.359) were similar. The prevalence of participants reporting hypoglycemia in the past year was higher with IHSG wording (13.5% vs. 10.5%; p < 0.001); this difference was significantly (p < 0.001) larger among patients with impaired awareness of hypoglycemia. Association of both definitions with level-3-H risk factors was comparable., Conclusions: The level-3-H episodes by PP and IHSG wording were comparable. The simplicity of PP wording may allow better mutual understanding between patients and healthcare team., Trial Registration: NCT03720197 (registered on October 19th 2018)., (© 2022. Springer-Verlag Italia S.r.l., part of Springer Nature.)

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., (Copyright © 2022 Elsevier Inc. All rights reserved.)

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., (Copyright © 2022. Published by Elsevier Masson SAS.)

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., Competing Interests: Financial Disclosure Loïc Sentilhes carried out consultancy work and was a lecturer for Ferring Laboratories in the previous 3 years. The other authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

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., Competing Interests: Financial Disclosure Loïc Sentilhes has conducted consultancy work and lectured for Ferring Laboratories during the previous 3 years. The other authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Financial Disclosure Loïc Sentilhes reports receiving funds from Ferring Pharmaceuticals. The other authors did not report any potential conflicts of interest.

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.)., (Copyright © 2021 Massachusetts Medical Society.)

Introduction : Postpartum hemorrhage (PPH) is a major cause of maternal death and severe maternal morbidity after childbirth. Areas covered : Tranexamic acid, an antifibrinolytic agent, reduces bleeding-related mortality in women with PPH, especially when administered shortly after delivery, and is consequently recommended in this situation (1g intravenously with a second dose of 1 g if bleeding continues), even in high income countries where the magnitude of the effect of tranexamic is uncertain. Expert opinion : Pharmacovigilance surveys are warranted in high income areas to ensure that this new policy for the treatment of PPH is not associated to rare but severe adverse events such as renal failure. The evidence remains insufficient to recommend the universal use of tranexamic acid for prevention of postpartum hemorrhage after both vaginal and cesarean deliveries.

Background: To assess both severe maternal and neonatal mortality and morbidity after attempted operative vaginal deliveries by residents under supervision and by attending obstetricians., Study Design: Secondary analysis of a 5-year prospective study with cross-sectional analysis including 2192 women with live singleton term fetuses in vertex presentation who underwent an attempted operative vaginal delivery in a tertiary care university hospital. Obstetricians who attempted or performed an operative vaginal delivery were classified into 2 groups according to their level of experience: attending obstetricians (who had 5 years or more of experience) and obstetric residents (who had less than 5 years of experience) under the supervision of an attending obstetrician. We used multivariate logistic regression and propensity score methods to compare outcomes associated with attending obstetricians and obstetric residents. Severe maternal morbidity was defined as third- or fourth-degree perineal laceration, perineal hematoma, cervical laceration, extended uterine incision for cesareans, postpartum hemorrhage >1500 mL, surgical hemostatic procedures, uterine artery embolization, blood transfusion, infection, thromboembolic events, admission to the intensive care unit, or maternal death; severe neonatal morbidity was defined as a 5-minute Apgar score <7, umbilical artery pH <7.00, need for resuscitation or intubation, neonatal trauma, intraventricular hemorrhage greater than grade 2, neonatal intensive care unit admission for more than 24 hours, convulsions, sepsis, or neonatal death., Results: High prepregnancy body mass index, high dose of oxytocin, manual rotation, persistent occiput posterior or transverse positions, operating room delivery, midpelvic delivery, forceps, and spatulas were significantly more frequent in deliveries managed by attending obstetricians than residents whereas a second-stage pushing phase longer than 30 minutes was significantly more frequent in deliveries managed by residents. The rate of severe maternal morbidity was 7.8% (115/1475) for residents vs 9.9% (48/484) for attending obstetricians; for severe neonatal morbidity, the rates were 8.3% (123/1475) vs 15.1% (73/484), respectively. In the univariate, multivariable, and sensitivity analyses, attempted operative vaginal delivery managed by a resident was significantly and inversely associated with severe neonatal but not maternal morbidity. After propensity score matching, delivery managed by a resident was not significantly associated with severe maternal morbidity (adjusted odds ratio, 0.74; 95% confidence interval, 0.39-1.38) and was no longer associated with neonatal morbidity (adjusted odds ratio, 0.51; 95% confidence interval, 0.25-1.04)., Conclusion: Management of attempted operative vaginal deliveries by residents under the supervision of attending obstetricians, compared with by the attending obstetricians themselves, does not appear to be associated with either maternal or neonatal morbidity. These reassuring results support the continued use of residency programs for training in operative vaginal deliveries under the supervision of attending obstetricians., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To investigate the association between twin pregnancy and severe acute maternal morbidity, overall and by timing (before, during or after delivery) and underlying causal condition., Methods: We conducted a cohort-nested case-control analysis from the EPIMOMS prospective study conducted in six French regions from 2012-2013 (N=182,309 deliveries). The case group comprised 2,500 women with severe acute maternal morbidity (defined by a national expert consensus process) occurring from 22 weeks of gestation and up to 42 days postpartum. A random sample of 3,650 women who gave birth without severe acute maternal morbidity made up the control group. The association between twin pregnancy and severe acute maternal morbidity was analyzed with multilevel multivariable logistic regression. The role of cesarean delivery as an intermediate factor between twin pregnancy and severe acute maternal morbidity was assessed by path analysis., Results: The population-based incidence of severe acute maternal morbidity was 6.2% (n=197/3,202, 95% CI 5.3-7.1) in twin pregnancies, and 1.3% (n=2,303/179,107, 95% CI 1.2-1.3) in singleton pregnancies. After controlling for confounders, the risk of severe acute maternal morbidity was higher in twin than in singleton pregnancies (adjusted odds ratio [OR] 4.2, 95% CI 3.1-5.8), both antepartum and intrapartum or postpartum, and regardless of the category of causal condition (severe hemorrhage, severe hypertensive complications, or other conditions). The association was also found for the most severe near-miss cases (adjusted OR 5.1, 95% CI 3.5-7.3). In path analysis, cesarean delivery mediated 20.6% (95% CI 12.9-28.2) of the total risk of intrapartum or postpartum severe acute maternal morbidity associated with twin pregnancy., Conclusion: Compared with women with singleton pregnancies, women with twin pregnancies have a fourfold increased risk for severe maternal complications both before and after delivery. About one fifth of the association between twin pregnancy and intrapartum or postpartum severe acute maternal morbidity may be mediated by cesarean delivery.

In France, the frequency of premature rupture of the membranes (PROM) is 2%-3% before 37 weeks' gestation (level of evidence [LE] 2) and less than 1% before 34 weeks (LE2). Preterm delivery and intrauterine infection are the major complications of preterm PROM (PPROM) (LE2). Prolongation of the latency period is beneficial (LE2). Compared with other causes of preterm delivery, PPROM is associated with a clear excess risk of neonatal morbidity and mortality only in cases of intrauterine infection, which is linked to higher rates of in utero fetal death (LE3), early neonatal infection (LE2), and necrotizing enterocolitis (LE2). The diagnosis of PPROM is principally clinical (professional consensus). Tests to detect IGFBP-1 or PAMG-1 are recommended in cases of uncertainty (professional consensus). Hospitalization is recommended for women diagnosed with PPROM (professional consensus). Adequate evidence does not exist to support recommendations for or against initial tocolysis (Grade C). If tocolysis is prescribed, it should not continue longer than 48 h (Grade C). The administration of antenatal corticosteroids is recommended for fetuses with a gestational age less than 34 weeks (Grade A) and magnesium sulfate if delivery is imminent before 32 weeks (Grade A). The prescription of antibiotic prophylaxis at admission is recommended (Grade A) to reduce neonatal and maternal morbidity (LE1). Amoxicillin, third-generation cephalosporins, and erythromycin (professional consensus) can each be used individually or eythromycin and amoxicillin can be combined (professional consensus) for a period of 7 days (Grade C). Nonetheless, it is acceptable to stop antibiotic prophylaxis when the initial vaginal sample is negative (professional consensus). The following are not recommended for antibiotic prophylaxis: amoxicillin-clavulanic acid (professional consensus), aminoglycosides, glycopeptides, first- or second-generation cephalosporins, clindamycin, or metronidazole (professional consensus). Women who are clinically stable after at least 48 h of hospital monitoring can be managed at home (professional consensus). Monitoring should include checking for clinical and laboratory factors suggestive of intrauterine infection (professional consensus). No guidelines can be issued about the frequency of this monitoring (professional consensus). Adequate evidence does not exist to support a recommendation for or against the routine initiation of antibiotic therapy when the monitoring of an asymptomatic woman produces a single isolated positive result (e.g., elevated CRP, or hyperleukocytosis, or a positive vaginal sample) (professional consensus). In cases of intrauterine infection, the immediate intravenous administration (Grade B) of antibiotic therapy combining a beta-lactam with an aminoglycoside (Grade B) and early delivery of the child are both recommended (Grade A). Cesarean delivery of women with intrauterine infections is reserved for the standard obstetric indications (professional consensus). Expectant management is recommended for uncomplicated PROM before 37 weeks (Grade A), even when a sample is positive for Streptococcus B, as long as antibiotic prophylaxis begins at admission (professional consensus). Oxytocin and prostaglandins are two possible options for the induction of labor in women with PPROM (professional consensus)., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Postpartum haemorrhage (PPH) is a major cause of maternal morbidity and one of the leading causes of maternal mortality worldwide. Many medical treatments and interventions are available nowadays, but surgical treatment is sometimes required when less invasive methods are unsuccessful. This study aimed to assess the theoretical and practical knowledge of French residents of Obstetrics and Gynecology concerning the surgical treatment of postpartum haemorrhage., Study Design: We performed a questionnaire study for senior residents of Obstetrics and Gynecology in France (fourth and fifth year of training). An anonymous survey was sent by email. Between December 2013 and April 2014, a total of 370 residents responded., Result: The response rate was 47.6% (176/370). Only 156 questionnaires were fully completed and included for analysis. In all, 74% (115/156) of residents reported not mastering sufficiently or at all the technique for bilateral ligation of uterine arteries, 79% (123/156) for uterine compression sutures, 95% (148/156) for ligation of the internal iliac arteries, and 78% (122/156) for emergency peripartum hysterectomy. More than half of respondents (55%, 86/156) stated that they had not mastered any of these techniques., Conclusion: An alarmingly high number of French senior residents in Obstetrics and Gynecology report that they have not acquired the sufficient surgical skills during their training to be able to perform the surgeries required for the management of PPH.

Turner syndrome is a common sex chromosome disorder characterized by complete or partial absence of an X chromosome. The spectrum of its clinical features and cytogenetics are various. We report new chromosomal formula revealed by DSD and associated with translocation (13,14). To our knowledge, this is the first case of 45X, t(13;14) de novo translocation as a variation of Turner syndrome in a patient with this clinical presentation.

Our study aimed to assess the prevalence of post-traumatic stress disorder (PTSD) after childbirth one year after vaginal delivery and to identify characteristics of women and deliveries associated with it. Questionnaires were mailed a year after delivery to 1103 women with prospectively collected delivery and postpartum data, including a question on day 2 assessing their experience of childbirth. PTSD was assessed a year later by the Impact of Event and Traumatic Event Scales; 22 women (4.2%, 95%CI 2.7-6.3%) met the PTSD diagnostic criteria and 30 (5.7%; 95%CI 3.9-8.0%) PTSD profile criteria. Factors associated with higher risk of PTSD profile were previous abortion (aOR 3.6, 95%CI 1.4-9.3), previous postpartum hemorrhage (Aor 5.3, 95%CI 1.3-21.4), and postpartum hemoglobin <9 g/dl (aOR 2.7, 95%CI 1.0-7.5). Among 56 women (10.3%) reporting bad childbirth memories at day 2 postpartum, 11 (21.1%) met PTSD diagnosis and 11 (21.1%) PTSD profile criteria a year later, compared with 11 (2.4%) (P < 0.001) and 18 (3.8%) (P < 0.001), respectively, of the 489 (87.7%) women with good memories. PTSD is not rare at one year after vaginal delivery in a low-risk population. A simple question at day 2 post partum may identify women most at risk of PTSD and help determine if early intervention is needed.

Objective: To evaluate the effect of the fetal head station at attempted operative vaginal delivery (aOVD), and specifically midpelvic or low aOVD, on female and male sexual function and symptoms of postpartum depression (PPD) at 6 months., Design: Prospective population-based cohort study., Setting: 1,941 women with singleton term fetuses in vertex presentation with midpelvic or low aOVD between 2008 and 2013 in a tertiary care university hospital., Methods: Symptoms of female sexual dysfunction using the Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Short Form Questionnaire (PISQ-12), symptoms of PPD using the Edinburgh Postnatal Depression Scale (EPDS) score, symptoms of male sexual dysfunction using the International Index of Erectile Function (IIEF-15) and perineal pain were assessed 6 months after aOVD. We measured the association between midpelvic or low aOVD and symptoms of female and male sexual function and symptoms of PPD at 6 months using multiple regression and adjusting for demographics, and risk factors of sexual dysfunction, symptoms of PPD and perineal pain with adjusted odds ratios (aORs) and 95% confidence intervals (95% CI)., Results: The study included 907 women (46.7%) who responded to the questionnaire; 18.4% (167/907) had midpelvic aOVD, and 81.6% (740/907) low. Most women (873/907 [96.3%]) of those with partners reported sexual activity at 6 months. No significant difference was observed for PISQ-12, EPDS, IIEF-15 scores and perineal pain between mid and low pelvic groups. Compared with low pelvic aOVD, midpelvic aOVD was not significantly associated with either female or male sexual dysfunction (p = 0.89 and p = 0.76, respectively), or maternal symptoms of PPD (p = 0.83). Perineal pain significantly increased the risk of male and female sexual dysfunction and maternal symptoms of PPD at 6 months (p = 0.02, p = 0.006, and p = 0.02, respectively)., Conclusion: Midpelvic compared with low pelvic aOVD was not associated with an increase in sexual dysfunction, nor with symptoms of PPD at 6 months.

Objective: To evaluate the effect of the fetal head station at attempted operative vaginal delivery (aOVD), and specifically midpelvic or low aOVD, on urinary incontinence (UI), anal incontinence (AI), and perineal pain at 6 months., Design: Prospective cohort study., Setting: 1941 women with singleton term fetuses in vertex presentation with midpelvic or low aOVD between 2008 and 2013 in a tertiary care university hospital., Methods: Symptoms of urinary incontinence (UI) using the Bristol Female Lower Urinary Tract Symptoms questionnaire, and symptoms of anal incontinence (AI) severity using Fecal Incontinence Severity Index (FISI) were assessed 6 months after aOVD. We measured the association between midpelvic or low aOVD and symptoms of UI, AI, and perineal pain at 6 months using multiple regression and adjusting for demographics, and risk factors of UI and AI, with adjusted odds ratios (aORs) and 95% confidence intervals (95% CI)., Results: The study included 907 women (46.7%) who responded to the questionnaire; 18.4% (167/907) had midpelvic aOVD, and 81.6% (740/907) low; and none of women with symptoms of UI (26.6%, and 22.4%, respectively; p = 0.31), AI (15.9%, and 21.8%; p = 0.09), the FISI score, and perineal pain (17.2%, and 12.7%; p = 0.14) differed significantly between groups. The same was true for stress, urge, and mixed-type UI, severe UI and difficulty voiding. Compared with low pelvic aOVD, the aORs for symptoms of UI in midpelvic aOVD were 0.70 (0.46-1.05) and AI 1.42 (0.85-2.39). Third- and fourth-degree tears were a major risk factor of symptoms of UI (aOR 3.08, 95% CI 1.35-7.00) and AI (aOR 3.47, 95% CI 1.43-8.39)., Conclusion: Neither symptoms of urinary nor anal incontinence differed at 6 months among women who had midpelvic and low pelvic aOVD. These findings are reassuring and need further studies at long-term to confirm these short-term data., Competing Interests: The authors have declared that no competing financial interests exist.

Introduction: Postpartum hemorrhage (PPH) is one of the leading causes of maternal death and severe maternal morbidity worldwide and strategies to prevent and treat PPH vary among international authorities. Areas covered: This review seeks to provide a global overview of PPH (incidence, causes, risk factors), prevention (active management of the third stage of labor and prohemostatic agents), treatment (first, second and third-line measures to control PPH), by also underlining recommendations elaborated by international authorities and using algorithms. Expert commentary: When available, oxytocin is considered the drug of first choice for both prevention and treatment of PPH, while peripartum hysterectomy remains the ultimate life-saving procedure if pharmacological and resuscitation measures fail. Nevertheless, the level of evidence for preventing and treating PPH is globally low. The emergency nature of PPH makes randomized controlled trials (RCT) logistically difficult. Population-based observational studies should be encouraged as they can usefully strengthen the evidence base, particularly for components of PPH treatment that are difficult or impossible to assess through RCT.

The aim of our study was to assess the theoretical and practical knowledge of French obstetricians about the surgical management of postpartum haemorrhage (PPH). Our study is a national anonymous self-administered survey. A total of 363 obstetricians responded to this questionnaire between December 2013 and April 2014. Questionnaire sent through email to all French obstetricians who are members of either of two federations of hospital-based obstetricians. Answers were collected until the end of June 2014. The main outcome measure was obstetricians' level of mastery of each surgical technique. The results were analysed descriptively (proportions). Only the 286 questionnaires fully completed were analysed; the complete response rate was 23% (286/1246). In all, 33% (95/286) of the responding obstetricians reported that they had not mastered sufficiently or even at all the technique for bilateral ligation of the uterine arteries, 37% (105/286) for uterine compression suture, 62% (178/286) for ligation of the internal iliac arteries, and 47% (134/286) for emergency peripartum hysterectomy. In all, 18% (52/286) of respondents stated that they had not mastered any of these techniques. Our study shows that a worrisome number of French obstetricians reported insufficient mastery of the surgical techniques for PPH management.

The aim of our study was to assess the feasibility of implementing a protocol for the use of magnesium sulfate to prevent cerebral palsy. This retrospective single-center study included all women with fetuses of gestational age <33 weeks of gestation whose birth was planned or expected within 24 hours from September 2011 to December 2012. They were to receive magnesium sulfate, administered intravenously as a 4-g bolus followed by a constant infusion of 1 g per hour. If delivery had not occurred after 12 hours and was no longer considered imminent, the infusion was to be discontinued. The study included 119 women, 81 (68.1%) of whom received magnesium sulfate. Among the latter, 71 (87.5%) gave birth within 24 hours. The reasons treatment was not given were: omission by medical team (19/38, 50%), urgent delivery (18/38, 47.4%), and contraindication to treatment (1/38, 2.6%). The mean gestational age at protocol implementation was 29.6 +/- 2.1 weeks. Maternal monitoring, especially at the onset of infusion, appeared suboptimal. No major maternal side effects were observed. Our study shows that implementing a protocol for prevention of cerebral palsy by magnesium sulfate is feasible in a tertiary obstetric center.

Aim: This paper is a report of a study conducted to examine factors (severity and duration of the disease, credible authority, social support, education) that may influence the level of uncertainty and stress in patients having peritoneal dialysis., Background: Although home peritoneal dialysis improves the patient's quality of life, it has both physiological and psychosocial disadvantages. These disadvantages, along with the experience of chronic disease (end-stage renal disease), create strong feelings of stress and uncertainty. Few studies have examined the correlation between the peritoneal dialysis experience and this level of uncertainty., Method: The sample comprised 71 patients having peritoneal dialysis. Their average age was 57 years (SD = 12.8), average number of years of education was 11.9 (SD = 3.25), and average time on peritoneal dialysis was 30.6 months (SD = 12.8). Data were collected from February to June 2004; the subjects answered a questionnaire comprising medical data, perception of the nurse and/or physician as epistemic authority, satisfaction with social support, level of uncertainty regarding the disease, its treatment and outcomes, and level of stress., Findings: Only patients' self-rated health and level of education, and doctors' epistemic authority contributed statistically significantly to explaining patients' uncertainty. Level of education was found to affect both uncertainty and stress. The factors that most influenced patients' uncertainty were related to their ability to process information. Familiarity with their disease was less influential., Conclusion: Peritoneal dialysis nurses should be aware of the fact that they can reduce their patients' uncertainty and stress by helping them to maintain hope and to view their health status positively.

Objectives: To assess the effect of prolonging antibiotic prophylaxis in cardiac surgery., Methods: Prospective before-after cohort study. In 2004, cefazolin was given pre- and intraoperatively at 1g doses while in 2007 it was continued after surgery for 24h. All consecutive adult patients undergoing coronary artery bypass graft, valve, and/or aortic operations during the study periods were included. The primary outcomes were deep sternal wound infection (DSWI) and mortality. Univariate and multivariate analyses were conducted to assess risk factors for DSWI., Results: 954 patients between 1/2004 and 12/2004 were compared to 424 patients between 1/2007 and 6/2007. In 2007, there were significantly more patients >60yrs., emergency and combined operations and the mean logistic EuroSCORE was higher compared to 2004 (8.53% vs. 6.92%, p=0.006). The rate of DSWI decreased non-significantly from 3.8% (36/954) in 2004 to 2.6% (11/424) in 2007, p=0.27. The adjusted odds ratio of the study period for DSWI was 0.89 (95% confidence interval 0.70-1.13). There was no difference in 30-day (5.2% vs. 5.4%) or 6-month mortality (9.2% in both periods), despite increasing patients' risk., Conclusions: Increasing the duration of antibiotic prophylaxis did not result in a significant decrease in DSWI. The value of prolonging antibiotic prophylaxis after cardiac operations should be further evaluated.