Low-dose aspirin for the prevention of preterm birth in nulliparous women: systematic review and meta-analysis.

OBJECTIVE: The objective was to assess the efficacy and safety of low-dose aspirin for the prevention of preterm birth in nulliparous women. DATA SOURCES: We searched PubMed, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to June 2022. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials that compared aspirin to placebo in nulliparous women were eligible. METHODS: This study was reported in accordance with the PRISMA 2020 checklist. The primary outcomes of this study were the rates of preterm birth at less than 37 weeks and less than 34 weeks of gestation. The secondary outcomes included postpartum hemorrhage, placental abruption, cesarean section, any hypertensive disorder of pregnancy and small for gestational age. Relative risks with their 95% confidence intervals were calculated for analysis. Heterogeneity was assessed by Cochran's Q test and Higgins's I2. A random-effects model was used when I2 was > 50% to generate the RR and 95% CI; otherwise, a fixed-effects model was used. The risk of publication bias was assessed by funnel plots. We performed sensitivity analysis by sequentially omitting each included study to confirm the robustness of the analysis. RESULTS: Seven studies with a total of 29,029 participants were included in this review. Six studies were assessed as having a low risk of bias or an unclear risk of bias, and one study was judged as having a high risk of bias. In nulliparous women, low-dose aspirin was associated with a significant reduction in the rate of preterm birth at less than 34 weeks of gestational age (RR 0.84,95% CI: 0.71-0.99; I2 = 0%; P = 0.04), but we did not observe a significant difference in the rate of preterm birth at less than 37 weeks of gestation (RR 0.96,95% CI: 0.90-1.02; I2 = 31%; P = 0.18). Low-dose aspirin was associated with a significant increase in the rates of postpartum hemorrhage (RR 1.32,95% CI: 1.14-1.54; I2 = 0%; P = 0.0003), placental abruption (RR 2.18,95% CI: 1.10-4.32; I2 = 16%; P = 0.02) and cesarean section (RR 1.053, 95% CI: 1.001-1.108; I2 = 0%; P = 0.05) in nulliparous women. We also did not observe a significant effect of low-dose aspirin on the rates of any hypertensive disorder of pregnancy (RR 1.05, 95% CI: 0.96-1.14; I2 = 9%; P = 0.28) or small for gestational age (RR 0.96, 95% CI: 0.91-1.02; I2 = 0%; P = 0.16) in nulliparous women. Funnel plots indicated that no significant publication bias existed in this meta-analysis. Except for preterm birth at less than 34 weeks of gestation, placental abruption and cesarean section, the sensitivity analysis showed similar results, which confirmed the robustness of this meta-analysis. CONCLUSIONS: Low-dose aspirin might reduce the risk of preterm birth at less than 34 weeks of gestation in nulliparous women. The use of low-dose aspirin in nulliparous women increased the risk of postpartum hemorrhage and might increase the risk of placental abruption and cesarean section.

Effect of Bakri balloon tamponade combined with different suture methods on preventing postpartum hemorrhage in women with pregnancy-induced hypertension undergoing cesarean delivery.

OBJECTIVE: To investigate the effect of Bakri balloon tamponade (BBT) combined with different suture methods on preventing postpartum hemorrhage in women with pregnancy-induced hypertension (PIH) undergoing cesarean delivery (CD). METHODS: This randomized, double-blind, controlled trial was conducted at The First Affiliated Hospital of Xingtai Medical College from October 2020 to June 2023. Patients with PIH who had persistent bleeding after CD and were unresponsive to uterine contractions, sutures, or uterine disconnection procedures were eligible participants. Eligible participants were randomly assigned to control and study groups, with 50 patients in each group. The control group used BBT combined with B-lynch uterine compression sutures, while the study group used BBT combined with modified Hayman suture. Intraoperative and postoperative bleeding and changes in vital signs were compared between the 2 groups. Moreover, changes in inflammation levels, coagulation function, and sex hormone levels were compared between the 2 groups before and after surgery. RESULTS: A total of 122 patients with persistent bleeding after CD were recruited, of whom 22 were excluded (16 cases of uterine contractions and/or local uterine myometrial sutures for hemostasis, 4 cases of preoperative uterine artery embolization, and 2 cases of uterine malformations). The intraoperative blood loss, postoperative blood loss at 2 hours, postoperative blood loss at 24 hours, and decrease in red blood cell and hemoglobin in the study group were significantly lower than those in the control group (P < .05). After surgery, the levels of inflammation, coagulation function, and sex hormone in both groups improved compared to before surgery, and the study group was significantly better than the control group (P < .05). In addition, the incidence of postoperative adverse events in the study group was significantly lower than that in the control group (P < .05). CONCLUSIONS: The hemostatic effect of BBT combined with B-lynch uterine compression sutures is comparable to that of BBT combined with modified Hayman suture for postpartum hemorrhage in pregnant women with PIH undergoing CD, but the latter has less blood loss, attenuated inflammatory response, reduced impact on coagulation function and ovarian function, and a lower incidence of adverse events.

Prophylactic tranexamic acid in Cesarean delivery: an updated meta-analysis with a trial sequential analysis.

PURPOSE: Postpartum hemorrhage (PPH) is a leading cause of maternal mortality worldwide. Although several studies on the prophylactic use of tranexamic acid (TXA) in parturients undergoing Cesarean delivery have been published, conflicting results raise questions regarding its use. Thus, we aimed to investigate the safety and efficacy of PPH prophylaxis with TXA. SOURCE: We searched PubMed®, Embase, Cochrane Central, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing prophylactic TXA with placebo or no treatment in parturients undergoing Cesarean delivery. Our main outcomes were PPH, any blood transfusion, need for additional uterotonics, and adverse events. We performed a trial sequential analysis (TSA) of all outcomes to investigate the reliability and conclusiveness of findings. PRINCIPAL FINDINGS: We included 38 RCTs including 22,940 parturients, 11,535 (50%) of whom were randomized to receive prophylactic TXA. Patients treated with TXA had significantly fewer cases of PPH (risk ratio [RR], 0.51; 95% confidence interval [CI], 0.38 to 0.69; P < 0.001); less blood transfusion (RR, 0.43; 95% CI, 0.30 to 0.61; P < 0.001), and less use of additional uterotonics (RR, 0.52; 95% CI, 0.40 to 0.68; P < 0.001). No significant differences were found between the groups in terms of adverse effects and thromboembolic events. CONCLUSION: Prophylactic TXA administration for parturients undergoing Cesarean delivery significantly reduced blood loss, without increasing adverse events, supporting its use as a safe and effective strategy for reducing PPH in this population. STUDY REGISTRATION: PROSPERO (CRD42023422188); first submitted 27 April 2023.

RéSUMé: OBJECTIF: L'hémorragie du post-partum (HPP) est l'une des principales causes de mortalité maternelle dans le monde. Bien que plusieurs études sur l'utilisation prophylactique d'acide tranexamique (TXA) chez les personnes parturientes ayant accouché par césarienne aient été publiées, des résultats contradictoires soulèvent des questions quant à son utilisation. Ainsi, nous avons cherché à étudier l'innocuité et l'efficacité de la prophylaxie à base de TXA pour l'HPP. SOURCES: Nous avons fait une recherche sur PubMed®, Embase, Cochrane Central et ClinicalTrials.gov pour en tirer les études randomisées contrôlées (ERC) comparant le TXA prophylactique à un placebo ou à l'absence de traitement chez les personnes parturientes accouchant par césarienne. Nos principaux critères d'évaluation étaient l'HPP, toute transfusion sanguine, la nécessité d'un utérotonique supplémentaire et les événements indésirables. Nous avons effectué une analyse séquentielle des études pour tous les résultats afin d'examiner la fiabilité et le caractère concluant des conclusions. CONSTATATIONS PRINCIPALES: Nous avons inclus 38 ERC comprenant 22 940 personnes parturientes, dont 11 535 (50 %) ont été randomisées pour recevoir du TXA prophylactique. La patientèle traitée par TXA présentait significativement moins de cas d'HPP (risque relatif [RR], 0,51; intervalle de confiance [IC] à 95 %, 0,38 à 0,69; P < 0,001); moins de transfusion sanguine (RR, 0,43; IC 95 %, 0,30 à 0,61; P < 0,001) et moins d'utilisation d'utérotoniques supplémentaires (RR, 0,52; IC 95 %, 0,40 à 0,68; P < 0,001). Aucune différence significative n'a été constatée entre les groupes en termes d'effets indésirables et d'événements thromboemboliques. CONCLUSION: L'administration prophylactique de TXA pour les personnes parturientes accouchant par césarienne a considérablement réduit les pertes de sang sans augmenter les événements indésirables, ce qui soutient son utilisation comme stratégie sécuritaire et efficace pour réduire l'HPP dans cette population. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42023422188); première soumission le 27 avril 2023.

Preventing postpartum hemorrhage: A network meta-analysis on routes of administration of uterotonics.

1. OBJECTIVE: To perform a network meta-analysis to specify the route of administration that maximises the effectiveness of each of the available prophylactic uterotonics without increasing the risk for side effects. 2. DATA SOURCES: Literature searches on 12th September 2022 included: CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. The reference lists of the retrieved study records were also searched. 3. STUDY ELIGIBILITY CRITERIA: Population: Randomized controlled trials involving women in the third stage of labour after a vaginal or caesarean delivery in hospital or community settings. INTERVENTIONS: Systemically administered prophylactic uterotonics of any route and dose for primary postpartum hemorrhage prevention. Comparison: Any other prophylactic uterotonic, or a different route or dose of a given uterotonic, or placebo, or no treatment. Outcomes (primary): postpartum hemorrhage ≥ 500 mL and ≥ 1000 mL. 4. STUDY APPRAISAL AND SYNTHESIS METHODS: Risk of bias and trustworthiness assessments were performed, according to Cochrane's guidance. Direct, indirect and network meta-analyses were conducted, and results were summarized either as risk ratio or mean difference with 95% confidence intervals for dichotomous and continuous outcomes, respectively. The certainty of generated evidence was assessed according to the GRADE approach. Cumulative probabilities were calculated and the surface under the cumulative ranking curve was used to create a ranking of the available drugs. 5. RESULTS: One hundred eighty-one studies involving 122,867 randomised women were included. Most studies were conducted in hospital settings in lower-middle income countries and involved women delivering vaginally. When compared with intramuscular oxytocin, carbetocin (RR 0.58, 95 % CI 0.40-0.84) and oxytocin (RR 0.75, 95 % CI 0.59-0.97) by an intravenous bolus, and intramuscular ergometrine plus oxytocin combination (RR 0.71, 95 % CI 0.56-0.91) are probably more effective in preventing primary postpartum hemorrhage. Intramuscularly administered oxytocin and carbetocin by an intravenous bolus have a favourable side effects profile. 6. CONCLUSIONS: Generated evidence was generally moderate and global inconsistency was low. Carbetocin and oxytocin by an intravenous bolus, and intramuscular ergometrine plus oxytocin combination are probably the top uterotonics for primary postpartum hemorrhage prevention. Large scale studies exploring different routes of administration for available prophylactic uterotonics, and women's views should be conducted.

Evaluating tranexamic acid for the prevention and treatment of obstetric hemorrhage.

PURPOSE OF REVIEW: Tranexamic acid (TXA) has emerged as a promising pharmacological adjunct to treat and prevent postpartum hemorrhage (PPH). We provide an overview of TXA, including its pharmacology, key findings of randomized trials and observational studies, and critical patient safety information. RECENT FINDINGS: Pharmacokinetic data indicate that TXA infusions result in peak plasma concentration within 3 min (range: 1-6.6 min). Ex-vivo pharmacodynamic data suggest that low-dose TXA (5 mg/kg) inhibits maximum lysis for at least 1 h. In predominantly developing countries, TXA has demonstrated a 19% reduction in the risk of bleeding-related death among patients with PPH. Based on high-quality randomized trials, TXA prophylaxis does not effectively reduce the risk of PPH during vaginal delivery and is likely ineffective in reducing the PPH risk during cesarean delivery. TXA exposure does not increase the risk of maternal thrombotic events. Maternal deaths have occurred from accidental intrathecal TXA injection from look-alike medication errors. SUMMARY: TXA has shown promise as an important adjunct for PPH treatment, especially in low-resource settings. However, TXA is not recommended as PPH prophylaxis during vaginal or cesarean delivery. Patient safety initiatives should be prioritized to prevent maternal death from accidental intrathecal TXA injection.

Improving maternal safety: Usability and performance assessment of a new medical device for the treatment of postpartum haemorrhage.

Postpartum haemorrhage (PPH) is an obstetric emergency causing nearly one-quarter of maternal deaths worldwide, 99% of these in low-resource settings (LRSs). Uterine balloon tamponade (UBT) devices are a non-surgical treatment to stop PPH. In LRSs, low-cost versions of UBT devices are based on the condom balloon tamponade (CBT) technique, but their effectiveness is limited. This paper discusses the experimental study to assess the usability and performance of a medical device, BAMBI, designed as an alternative to current CBT devices. The testing phase involved medical and non-medical personnel and was focused on testing BAMBI's usability and effectiveness compared to a standard CBT solution. We collected measures of the execution time and the procedure outcome. Different training procedures were also compared. Results show a significant preference for the BAMBI device. Besides, medical and non-medical subjects reached comparable outcomes. This aspect is highly relevant in LRSs where the availability of medical personnel could be limited.

Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial.

BACKGROUND: Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. OBJECTIVE: This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. STUDY DESIGN: The study is a double-blind randomized controlled trial. METHODS: The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. RESULTS: The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. CONCLUSION: Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363.

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.

Propensity score analysis of low-dose aspirin and bleeding complications in pregnancy.

OBJECTIVE: Low-dose aspirin (LDA) has been shown to reduce the risk of preterm pre-eclampsia and it has been suggested that it should be recommended for all pregnancies. However, some studies have reported an association between LDA and an increased risk of bleeding complications in pregnancy. Our aim was to evaluate the risk of placental abruption and postpartum hemorrhage (PPH) in patients for whom their healthcare provider had recommended prophylactic aspirin. METHODS: This multicenter cohort study included 72 598 singleton births at 19 hospitals in the USA, between January 2019 and December 2021. Pregnancies complicated by placenta previa/accreta, birth occurring at less than 24 weeks' gestation, multiple pregnancy or those with data missing for aspirin recommendation were excluded. Propensity scores were calculated using 20 features spanning sociodemographic factors, medical history, year and hospital providing care. The association between LDA recommendation and placental abruption or PPH was estimated by inverse-probability treatment weighting using the propensity scores. RESULTS: We included 71 627 pregnancies in the final analysis. Aspirin was recommended to 6677 (9.3%) and was more likely to be recommended for pregnant individuals who were 35 years or older (P < 0.001), had a body mass index of 30 kg/m2 or higher (P < 0.001), had prepregnancy hypertension (P < 0.001) and who had a Cesarean delivery (P < 0.001). Overall, 1.7% of the study cohort (1205 pregnancies) developed preterm pre-eclampsia: 1.3% in the no-aspirin and 5.8% in the aspirin group. After inverse-probability weighting with propensity scores, aspirin was associated with increased risk of placental abruption (adjusted odds ratio (aOR), 1.44 (95% CI, 1.04-2.00)) and PPH (aOR, 1.21 (95% CI, 1.05-1.39)). The aOR translated to a number needed to harm with LDA of 79 (95% CI, 43-330) for PPH and 287 (95% CI, 127-3151) for placental abruption. CONCLUSIONS: LDA recommendation in pregnancy was associated with increased risk for placental abruption and for PPH. Our results support the need for more research into aspirin use and bleeding complications in pregnancy before recommending it beyond the highest-risk pregnancies. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Weight-based versus fixed dose oxytocin infusion for preventing uterine atony during cesarean section in laboring patients: A randomized trial.

OBJECTIVE: We compared efficacy of weight-based (0.4 IU/kg/h) versus fixed-dose (34 IU/h) oxytocin infusion during cesarean section. METHODS: The oxytocin infusion in either group (n = 32 each) was initiated upon cord clamping. Primary outcome measure was adequacy of uterine tone at 4 min after initiating oxytocin infusion. Oxytocin associated side effects were also observed. RESULTS: Significantly less oxytocin was used with the weight-based versus fixed-dose regimen (16.3 [11.2-22.4] IU vs 20.4 [15.8-26.9] IU; P = 0.036). Incidence of adequate uterine tone was clinically greater but not significantly different with the weight-based versus fixed-dose regimen (81.3% vs 71.9%; P = 0.376). The weight-based regimen was associated with clinically lesser, although not statistically significant need for rescue oxytocin (25% vs 46.9%; P = 0.068) and additional uterotonic (9.4% vs 15.6%; P = 0.708); as well as oxytocin associated side effects (hypotension [34.4% vs 46.9%; P = 0.309], nausea/vomiting [18.8% vs 40.6%; P = 0.055], and ST-T changes [0% vs 3.1%; P = 1.000]). CONCLUSION: Weight-based oxytocin was not significantly different from the fixed-dose regimen in terms of uterotonic efficacy or associated side-effects, despite significantly lower doses being used. Use of weight-based oxytocin infusion (0.4 IU/kg/h) can be considered in clinical practice. TRIAL REGISTRATION: Clinical Trial Registry of India (ctri.nic.in, number. CTRI/2021/01/030642).

Awareness and use of tranexamic acid in the management of postpartum hemorrhage among health care professionals in Enugu, Nigeria.

OBJECTIVES: This study was conducted to determine the knowledge, practice, and barriers regarding the use of tranexamic acid (TXA) for the prevention and treatment of postpartum hemorrhage (PPH) among health care providers in Enugu, Nigeria. METHODS: A cross-sectional study was conducted among health professionals (doctors, pharmacists, and nurses) in two Nigerian tertiary teaching hospitals (one federal and one state). A total of 220 questionnaires were distributed and 207 were returned (response rate: 94%) and analyzed using SPSS for inferential statistics with a level of significance of P < 0.05. RESULTS: Only 23.7% of the respondents had good knowledge of TXA use in PPH (P < 0.001), and awareness of the recent World Health Organization (WHO) recommendation on the use of TXA for PPH was low (19.8%, P < 0.001). The majority of the respondents had neither prescribed nor dispensed TXA (30%, P < 0.001). Very few respondents used TXA for all cases of PPH (16.4%, P < 0.001). Barriers against its use include nonawareness of the latest WHO recommendation, preference for other uterotonics, and cost of the drug. CONCLUSIONS: There was poor knowledge of TXA, poor awareness of its recommendation, and low use for PPH among different cadres of health care providers.

Heat stable carbetocin or oxytocin for prevention of postpartum hemorrhage among women at risk: A secondary analysis of the CHAMPION trial.

OBJECTIVE: To examine whether the observed non-inferiority of heat-stable carbetocin (HSC), compared with oxytocin, was influenced by biologic (macrosomia, parity 3 or more, or history of postpartum hemorrhage [PPH]) and/or pharmacologic (induction or augmentation) risk factors for PPH. METHODS: The present study is a secondary analysis of the CHAMPION non-inferiority randomized trial-a two-arm, double-blind, active-controlled study conducted at 23 hospitals in 10 countries, between July 2015 and January 2018. Women with singleton pregnancies, expected to deliver vaginally with cervical dilatation up to 6 cm were eligible. Randomization was stratified by country, with 1:1 assignment. Women in the intervention and control groups received a single intramuscular injection of 100 µg of HSC or 10 IU of oxytocin, respectively. The drugs were administered immediately after birth, and the third stage of labor was managed according to the WHO guidelines. Blood was collected using a plastic drape. For this analysis, we defined a woman as being at risk if she had any one or more of the biologic or pharmacologic risk factor(s). RESULTS: The HSC and oxytocin arms contained 14 770 and 14 768 women, respectively. The risk ratios (RR) for PPH were 1.29 (95% confidence interval [CI] 1.08-1.53) or 1.73 (95% CI 1.51-1.98) for those with only biologic (macrosomia, parity 3 or more, and PPH in the previous pregnancy) or only pharmacologic (induced or augmented) risk factors, respectively, compared with those with neither risk factors. CONCLUSIONS: Findings reinforce previous evidence that macrosomia, high parity, history of PPH, and induction/augmentation are risk factors for PPH. We did not find a difference in effects between HSC and oxytocin for PPH among women who were neither induced nor augmented or among those who were induced or augmented.

Evaluation of labor management practices during spontaneous labor.

INTRODUCTION: In 2017, the French national authority for health issued national guidelines to support physiologic labor and reduce medical interventions. This study's primary aim was to evaluate the association between the publication of these guidelines and the vaginal delivery rate in a type IIb perinatal center. The secondary objectives were to evaluate the implementation of these guidelines, their association with the duration of labor, and the rates of postpartum hemorrhage and adverse neonatal outcomes. MATERIAL AND METHODS: A before-and-after, retrospective, single-center study comparing a "before" group (2016) and an "after" group (2018), one year after the recommendations were published. Women were eligible if they had no prior cesarean delivery and gave birth after 37 weeks of gestation to a singleton fetus in cephalic presentation after spontaneous labor. The analysis was stratified by parity. RESULTS: Oxytocin administration decreased between the two periods (48% vs 35 %, P < 0.0001), as did the frequency of amniotomies (artificial rupture of membranes) (39.5 % vs 27.7 %, P < 0.0001). The duration of labor was significantly prolonged (360 vs 390 min, P < 0.0001), especially in nulliparous women (465 min vs 562 min, P<0.0001). The frequency of vaginal delivery rose between the two periods (94.6 % vs 96 %, P = 0.05), and the postpartum hemorrhage rate fell (6 % vs 4.5 %, P = 0.04). The numbers of neonates with an umbilical artery pH< 7.10 and of neonatal transfers also decreased. CONCLUSIONS: The reduction of active interventions during labor is associated with a longer duration of labor and a decrease in the rates of cesarean births, postpartum hemorrhages, and neonatal transfers.

Tranexamic acid by the intramuscular or intravenous route for the prevention of postpartum haemorrhage in women at increased risk: a randomised placebo-controlled trial (I'M WOMAN).

BACKGROUND: Postpartum haemorrhage (PPH) causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a life-saving treatment for women with PPH. Intravenous (IV) TXA reduces deaths due to PPH by one-third when given within 3 h of childbirth. Because TXA is more effective when given early and PPH usually occurs soon after childbirth, giving TXA just before childbirth might prevent PPH. Although several randomised trials have examined TXA for PPH prevention, the results are inconclusive. Because PPH only affects a small proportion of births, we need good evidence on the balance of benefits and harms before using TXA to prevent PPH. TXA is usually given by slow IV injection. However, recent research shows that TXA is well tolerated and rapidly absorbed after intramuscular (IM) injection, achieving therapeutic blood levels within minutes of injection. METHODS: The I'M WOMAN trial is an international, multicentre, three-arm, randomised, double-blind, placebo-controlled trial to assess the effects of IM and IV TXA for the prevention of PPH in women with one or more risk factors for PPH giving birth vaginally or by caesarean section. DISCUSSION: The trial will provide evidence of the benefits and harms of TXA for PPH prevention and the effects of the IM and IV routes of administration. The IM route should be as effective as the IV route for preventing bleeding. There may be fewer side effects with IM TXA because peak blood concentrations are lower than with the IV route. IM TXA also has practical advantages as it is quicker and simpler to administer. By avoiding the need for IV line insertion and a slow IV injection, IM administration would free up overstretched midwives and doctors to focus on looking after the mother and baby and expand access to timely TXA treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT05562609. Registered on 3 October 2022. ISRCTN Registry ISRCTN12590098. Registered on 20 January 2023. Pan African Clinical Trial Registry PACTR202305473136570. Registered on 18 May 2023.

Utilization of non-pneumatic anti-shock garment for treating obstetric hemorrhage and associated factors among obstetric care providers in Ethiopia: A systematic review and meta-analysis.

BACKGROUND: The non-pneumatic anti-shock garment (NASG) is a life-saving device that can help to avoid delays and prevent further complications in the case of obstetric hemorrhage. Although there are many fragmented primary studies on the NASG utilization in Ethiopia, the pooled utilization rate is unknown. In addition, a disagreement was observed among those studies while reporting the associated factors. Therefore, this study was intended to determine the pooled level of NASG utilization and its associated factors among obstetric care providers in Ethiopia. METHODS: A total of 51 studies were retrieved from PubMed, Google Scholar, the African Journal of Online, direct open-access journals, and Ethiopian universities' institutional repositories. This study was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The quality of studies was evaluated using the modified Newcastle-Ottawa quality assessment tool. The data were extracted by two authors independently using Microsoft Excel and analyzed by Stata version 11. A random-effects model was applied to calculate the pooled level of NASG utilization and its associated factors. The PROSPERO registration number for the review is CRD42023414043. RESULT: A total of 8 studies comprising 2,575 study participants were involved in this meta-analysis. The pooled utilization rate of NASG was found to be 39.56%. Having NASG training (pooled odds ratio (OR) = 3.99, 95%CI = 2.35, 6.77), good knowledge about NASG (OR = 2.92, 95%CI = 2.04, 4.17), a positive attitude towards NASG (OR = 3.17, 95%CI = 2.10, 4.79), and having ≥ 2 NASGs in the health facility (OR = 10.59, 95%CI = 6.59, 17.01) were significantly associated with NASG utilization. CONCLUSION: Utilization of NASG for the treatment of obstetric hemorrhage was low in Ethiopia. To increase its utilization, Ministry of Health should improve the accessibility of NASG at each health facility and increase the Health professionals' knowledge and attitude through in-service and pre-service training.

Efficacy and safety of tranexamic acid in prevention of postpartum hemorrhage: a systematic review and meta-analysis of 18,649 patients.

BACKGROUND: In this meta-analysis, we aimed to update the clinical evidence regarding the efficacy and safety of TXA in the prevention of PPH. METHODS: A literature search of PubMed, Scopus, Web of Science, Google Scholar, and Cochrane Library from inception until December 2022 was conducted. We included randomized controlled trials (RCTs) comparing TXA with a placebo among pregnant women. All relevant outcomes, such as total blood loss, the occurrence of nausea and/or vomiting, and changes in hemoglobin, were combined as odds ratios (OR) or mean differences (MD) in the meta-analysis models using STATA 17 MP. RESULTS: We included 59 RCTs (18,649 patients) in this meta-analysis. For cesarean birth, TXA was favored over the placebo in reducing total blood loss (MD= -2.11 mL, 95%CI [-3.09 to -1.14], P < 0.001), and occurrence of nausea or/and vomiting (OR = 1.36, 95%CI [1.07 to 1.74], P = 0.01). For vaginal birth, the prophylactic use of TXA was associated with lower total blood loss, and higher occurrence of nausea and/or vomiting (MD= -0.89 mL, 95%CI [-1.47 to -0.31], OR = 2.36, 95%CI [1.32 to 4.21], P = 0.02), respectively. However, there were no differences between the groups in changes in hemoglobin during vaginal birth (MD = 0.20 g/dl, 95%CI [-0.07 to 0.48], P = 0.15). The overall risk of bias among the included studies varies from low to high risk of bias using ROB-II tool for RCTs. CONCLUSIONS: This meta-analysis suggested that TXA administration is effective among women undergoing cesarean birth or vaginal birth in lowering total blood loss and limiting the occurrence of PPH. Further clinical trials are recommended to test its efficacy on high-risk populations.

Harnessing the Power of Behavioral Science: An Implementation Pilot to Improve the Quality of Maternity Care in Rural Madagascar.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading direct cause of maternal deaths worldwide, and women in low-income countries are at particularly high risk of dying from PPH-related consequences. Most deaths can be avoided through consistent provider adherence to prevention protocols and timely, appropriate management, yet providers do not consistently adhere to these best practices. USING BEHAVIORAL DESIGN TO DEVELOP SOLUTIONS TO IMPROVE PROVIDER CARE: We applied the behavioral design methodology to identify behavioral drivers, develop solutions, and build a program theory of change. Implementation research was conducted to understand the adoption, desirability, feasibility, and appropriateness of the solutions and explore suggestive findings related to impact. Data were collected through observation and in-depth interviews. Solutions developed included: (1) a timer to remind providers of the 1-minute window to administer oxytocin; (2) a glow-in-the-dark poster illustrating a simplified algorithm for PPH management; (3) badges to assign family members tasks to support providers during labor and delivery; and (4) a risk visualization exercise. Clinical mentors introduced the solutions during facility visits, and providers received orientation using videos. Solutions were piloted in 10 rural facilities in southeastern Madagascar during November-December 2020. RESULTS: Providers reported high adoption of the timers and task badges during routine deliveries. They remarked on the desirability and appropriateness of the timer, task badges, and algorithm poster, as well as the value of the cocreation process. Adoption of the timer solution shows promise in having a potential positive impact on increasing the awareness of and adherence to timely oxytocin administration. CONCLUSION: This work highlights the promise of applying behavioral science to identify underlying drivers of gaps in clinical practice and to develop innovative and desirable solutions to address them.