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Placental Transfusion Strategies in Preterm Infants in Low- and Middle-Income Countries: A Systematic Review and Network Meta-Analysis
Ramaswamy VV, Bandyopadhyay T, Abiramalatha T, Shaik NB, Pullattayil SAk, Jasani B, Hegde V, Trevisanuto D, Weiner GM
Neonatology. 2022;:1-16
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Editor's Choice
Abstract
INTRODUCTION Placental transfusion strategies in preterm newborns have not been evaluated in low- and middle-income countries (LMICs). The objective of this systematic review was to compare placental transfusion strategies in preterm newborns in LMICs, including delayed cord clamping (DCC) for various time intervals, DCC until cord pulsations stop, umbilical cord milking, and immediate cord clamping (ICC). METHODS Medline, Embase, CINAHL, and CENTRAL were searched from inception. Observational studies and randomized controlled trials (RCTs) were included. Two authors independently extracted data for Bayesian random-effects network meta-analysis (NMA) if more than 3 interventions reported an outcome or a pairwise meta-analysis was utilized. RESULTS Among newborns <34 weeks of gestation, NMA of 9 RCTs could not rule out benefit or harm for survival from DCC 30-60 s compared to ICC: relative risk (RR) (95% credible interval) 0.96 (0.78-1.12), moderate certainty, or any included strategy compared to each other (low to very low certainty). Among late preterm newborns, DCC 120 s might be associated with improved survival: RR (95% confidence interval) 1.11 (1.01-1.22), very low certainty. We could not detect differences in the risk of intraventricular hemorrhage grade > II and bronchopulmonary dysplasia for any included intervention (low to very low certainty). DCC 60 s and 120 s might improve the hematocrit level among all preterm newborns (very low certainty), and DCC 45 s may decrease the risk of receipt of inotropes among newborns <34 weeks of gestation (low certainty). CONCLUSIONS In LMICs, DCC for 60 s and 120 s might improve hematocrit level in preterm newborns, and DCC for 45 s may decrease the risk of receipt of inotropes in newborns <34 weeks, with no conclusive effect on survival.
PICO Summary
Population
Preterm newborns in low- and middle-income countries (9 studies).
Intervention
Delayed cord clamping (DCC) for various time intervals.
Comparison
DCC until cord pulsations stop. Umbilical cord milking. Immediate cord clamping (ICC).
Outcome
Network meta-analysis of 9 randomised controlled trials could not rule out benefit or harm for survival from DCC 30-60s compared to ICC: relative risk (RR), (95% credible interval) 0.96 (0.78 to 1.12), moderate certainty, or any included strategy compared to each other (low to very low certainty). Among late preterm newborns, DCC 120s might be associated with improved survival: RR (95% confidence interval) 1.11 (1.01 to 1.22), very low certainty. Differences were not detected in the risk of intraventricular hemorrhage grade > II and bronchopulmonary dysplasia for any included intervention (low to very low certainty). DCC 60s and 120s might improve the haematocrit level among all preterm newborns (very low certainty), and DCC 45 s may decrease the risk of receipt of inotropes among newborns <34 weeks of gestation (low certainty).
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Intravenous oxytocin regimens in patients undergoing cesarean delivery: a systematic review and network meta-analysis of cluster-based groups
Tantry TP, Karanth H, Anniyappa S, Shetty PK, Upadya M, Shenoy SP, Kadam D
Journal of anesthesia. 2022
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Editor's Choice
Abstract
Information on evaluations of different oxytocin regimens used to prevent post-partum hemorrhage during cesarean delivery is scarce, and there is a lack of statistically pooled results for comparative doses. In this review, we aimed to analyze the effectiveness of different oxytocin regimens used and rank them accordingly. We performed a meta-analysis of randomized controlled trials (RCTs) reporting the incidence of additional uterotonic (AUT) use or amount of blood loss during cesarean delivery, where different oxytocin regimens were compared. Cluster analysis was used to define different clusters of oxytocin therapy based on the identified variable regimens. During the frequentist network meta-analysis, all clusters were compared to bolus clusters of dose range 3-5 IU. Data from 33 RCTs (6741 patients) to 26 RCTs (5422 patients) were assessed for AUT use and blood loss, respectively. Pairwise meta-analysis revealed a significant reduction in the use of AUTs or blood loss was recorded for bolus-infusion combination regimens. The network meta-analysis found that combined bolus-infusion regimens of (i) 3-5 IU and 0.25-1 IU/min or (ii) 3-5 IU and < 0.25 IU/min had statistically significant results for lowest consumption of AUTs (Ranks 1 and 2, respectively); whereas with the latter's use, the lowest blood loss (Rank 2) was observed. In contrast, the dose range, > 5 IU regimen was associated with higher side effects (lowest rank). During cesarean delivery, a significant reduction in the use of AUTs or blood loss (Rank 2) was recorded for bolus-infusion combination regimens. High doses did not have enough evidence to draw meaningful conclusions.
PICO Summary
Population
Patients undergoing cesarean delivery (37 studies, n= >7,000).
Intervention
Different intravenous oxytocin regimens (bolus, infusion, or a combination).
Comparison
Outcome
During the frequentist network meta-analysis, all clusters were compared to bolus clusters of dose range 3-5 IU. Data from 33 randomised controlled trials (RCTs), (6,741 patients) to 26 RCTs (5,422 patients) were assessed for additional uterotonic (AUT) use and blood loss, respectively. Pairwise meta-analysis revealed a significant reduction in the use of AUTs or blood loss was recorded for bolus-infusion combination regimens. The network meta-analysis found that combined bolus-infusion regimens of (i) 3-5 IU and 0.25-1 IU/min or (ii) 3-5 IU and < 0.25 IU/min had statistically significant results for lowest consumption of AUTs (Ranks 1 and 2, respectively); whereas with the latter's use, the lowest blood loss (Rank 2) was observed. In contrast, the dose range, > 5 IU regimen was associated with higher side effects (lowest rank). During cesarean delivery, a significant reduction in the use of AUTs or blood loss (Rank 2) was recorded for bolus-infusion combination regimens.
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Tranexamic acid for prevention of bleeding in caesarean Delivery: an overview of systematic reviews
Hurskainen T, Deng MX, Etherington C, Burns J, Martin Calderon L, Moher D, Edwards W, Boet S
Acta anaesthesiologica Scandinavica. 2021
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Editor's Choice
Abstract
BACKGROUND Bleeding is the leading cause of maternal mortality in the world. Tranexamic acid reduces bleeding in trauma and surgery. Several systematic reviews of randomized trials have investigated tranexamic acid in the prevention of bleeding in caesarean delivery. However, the conclusions from systematic reviews are conflicting. This overview aims to summarize the evidence and explore the reasons for conflicting conclusions across the systematic reviews. METHODS A comprehensive literature search of Medline, Embase, and Cochrane Database of Systematic Reviews was conducted from inception to April 2021. Screening, data extraction, and quality assessments were performed by two independent reviewers. A Measurement Tool to Assess Reviews 2 and the Risk of Bias Assessment Tool for Systematic Reviews were used for study appraisal. A qualitative synthesis of evidence is presented. RESULTS Fourteen systematic reviews were included in our analysis. Across these reviews, there were 32 relevant randomized trials. A modest reduction in blood transfusions and bleeding outcomes was found by most systematic reviews. Overall confidence in results varied from low to critically low. All of the included systematic reviews were at high risk of bias. Quality of evidence from randomized trials was uncertain. CONCLUSIONS Systematic reviews investigating prophylactic tranexamic acid in caesarean delivery are heterogeneous in terms of methodological and reporting quality. Tranexamic acid may reduce blood transfusion and bleeding outcomes, but rigorous well-designed research is needed due to the limitations of the included studies. Data on safety and adverse effects is insufficient to draw conclusions.
PICO Summary
Population
Patients undergoing caesarean delivery (14 studies).
Intervention
Overview of systematic reviews on tranexamic acid for the prevention of bleeding.
Comparison
Outcome
A modest reduction in blood transfusions and bleeding outcomes was found by most systematic reviews. Overall confidence in results varied from low to critically low. All of the included systematic reviews were at high risk of bias. Quality of evidence from randomized trials was uncertain.
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Tranexamic acid for the prevention of postpartum hemorrhage in women undergoing cesarean delivery: an updated meta-analysis
Bellos I, Pergialiotis V
American journal of obstetrics and gynecology. 2021
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Editor's Choice
Abstract
OBJECTIVE To assess the efficacy and safety of prophylactic tranexamic acid administration in comparison with standard uterotonic agents alone among women undergoing cesarean delivery. DATA SOURCES Medline, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, Clinicaltrials.gov and Google Scholar were systematically searched from inception to June 30, 2021. STUDY ELIGIBILITY CRITERIA Randomized controlled trials comparing intravenous tranexamic acid administration to placebo in women undergoing cesarean delivery and receiving standard prophylactic uterotonic agents were held eligible. STUDY APPRAISAL AND SYNTHESIS METHODS The risk of bias of individual studies was appraised with the RoB-2 tool. Meta-analysis was conducted by fitting random-effects models using restricted maximum likelihood. Subgroup analysis was performed based on country, protocol availability, double-blinding, risk of bias, sample size and tranexamic acid dose. One-stage meta-analysis was performed as a sensitivity analysis. The credibility of outcomes was appraised with the Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS Overall, 36 studies with 10,659 women were included. Tranexamic acid administration was associated with significantly lower total blood loss (Mean difference-MD: -189.44 ml, 95% confidence intervals-CI: -218.63; -160.25), lower hemoglobin drop (MD: 8.22%, 95% CI: 5.54; 10.90), decreased risk of blood loss >1000 ml (Odds ratio-OR: 0.37, 95% CI: 0.22; 0.60), transfusion requirement (OR: 0.41, 95% CI: 0.26; 0.65) and need of additional uterotonics (OR: 0.36, 95% CI: 0.25; 0.52). Subgroup analysis indicated a greater effect of tranexamic acid on total blood loss reduction in low-middle income countries. The outcomes remained stable by separately evaluating women at low bleeding risk. One-stage meta-analysis demonstrated similar outcomes with the primary analysis. The quality of evidence was judged to be moderate regarding total blood loss and hemoglobin percentage change and low for the other outcomes. CONCLUSIONS This meta-analysis suggests that prophylactic tranexamic acid administration is effective among women undergoing cesarean delivery in lowering postpartum blood loss and limiting hemoglobin drop. Further research is needed to test its efficacy in high-risk populations and to verify its safety profile.
PICO Summary
Population
Women undergoing caesarean delivery (36 studies, n= 10,659).
Intervention
Tranexamic acid.
Comparison
Standard uterotonic agents alone.
Outcome
Tranexamic acid administration was associated with significantly lower total blood loss (Mean difference (MD): -189.44 ml), lower haemoglobin drop (MD: 8.22%), decreased risk of blood loss >1000 ml, transfusion requirement and need of additional uterotonics. Subgroup analysis indicated a greater effect of tranexamic acid on total blood loss reduction in low-middle income countries. The outcomes remained stable by separately evaluating women at low bleeding risk. One-stage meta-analysis demonstrated similar outcomes with the primary analysis. The quality of evidence was judged to be moderate regarding total blood loss and haemoglobin percentage change and low for the other outcomes.
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Prenatal anemia and postpartum hemorrhage risk: A systematic review and meta-analysis
Omotayo MO, Abioye AI, Kuyebi M, Eke AC
The journal of obstetrics and gynaecology research. 2021
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Editor's Choice
Abstract
INTRODUCTION Postpartum hemorrhage (PPH) has remained the leading cause of maternal mortality. While anemia is a leading contributor to maternal morbidity, molecular, cellular and anemia-induced hypoxia, clinical studies of the relationship between prenatal-anemia and PPH have reported conflicting results. Therefore, our objective was to investigate the outcomes of studies on the relationships between prenatal anemia and PPH-related mortality. MATERIALS AND METHODS Electronic databases (MEDLINE, Scopus, ClinicalTrials.gov, PROSPERO, EMBASE, and the Cochrane Central Register of Controlled Trials) were searched for studies published before August 2019. Keywords included "anemia," "hemoglobin," "postpartum hemorrhage," and "postpartum bleeding." Only studies involving the association between anemia and PPH were included in the meta-analysis. Our primary analysis used random effects models to synthesize odds-ratios (ORs) extracted from the studies. Heterogeneity was formally assessed with the Higgins' I(2) statistics, and explored using meta-regression and subgroup analysis. RESULTS We found 13 eligible studies investigating the relationship between prenatal anemia and PPH. Our findings suggest that severe prenatal anemia increases PPH risk (OR = 3.54; 95% CI: 1.20, 10.4, p-value = 0.020). There was no statistical association with mild (OR = 0.60; 95% CI: 0.31, 1.17, p-value = 0.130), or moderate anemia (OR = 2.09; 95% CI: 0.40, 11.1, p-value = 0.390) and the risk of PPH. CONCLUSION Severe prenatal anemia is an important predictive factor of adverse outcomes, warranting intensive management during pregnancy. PROSPERO Registration Number: CRD42020149184; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=149184.
PICO Summary
Population
Pregnant women with prenatal anaemia (13 studies).
Intervention
Systematic review and meta-analysis to investigate the relationship between prenatal anaemia and postpartum haemorrhage (PPH) related mortality.
Comparison
Outcome
Severe prenatal anaemia was associated with increased PPH risk (OR = 3.54). There was no statistical association with mild (OR = 0.60), or moderate anaemia (OR = 2.09) and the risk of PPH.
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The definition, screening, and treatment of postpartum anemia: A systematic review of guidelines
Ruiz de Viñaspre-Hernández R, Gea-Caballero V, Juárez-Vela R, Iruzubieta-Barragán FJ
Birth (Berkeley, Calif.). 2020
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Editor's Choice
Abstract
BACKGROUND Postpartum anemia can negatively affect maternal health and interfere with early parenting. Thus, it is important to have clear, evidence-informed recommendations on its diagnosis and treatment. OBJECTIVE To compare global recommendations regarding the appropriate management of postpartum anemia and to highlight similarities and differences. METHODS Systematic searches were conducted in the databases PubMed, CINAHL, LILACS, TRIP database, and Scopus, and in the websites of health institutions and scientific societies. Search terms were related to anemia and the postpartum period. Two hundred and eighty papers were identified; the full texts of 30 sets of guidelines were reviewed, with seven being included in the final analysis. Recommendations were extracted through an evaluation of the evidence on the definition, screening, and diagnosis of anemia. The quality of the guidelines was assessed using the AGREE II instrument. RESULTS Two sets of guidelines have been elaborated by international organizations, and the rest were produced by professional associations within high-resource countries. The discrepancies found in the guidelines are important and affect the definition of anemia, the criteria for screening asymptomatic women, or the criteria guiding treatment. The quality of the guidelines commonly scored between 4 and 6 on a scale of 0 to 7. Recommendations with poor-quality evidence predominated over recommendations with high-quality evidence. CONCLUSIONS This review highlights the need to reach a consensus on the definition of postpartum anemia, to agree on what constitutes a problem for maternal health, and to provide recommendations that reach greater consensus on its diagnosis and treatment.
PICO Summary
Population
Women with postpartum anaemia.
Intervention
Systematic review comparing global recommendations regarding the appropriate management of postpartum anaemia, highlighting similarities and differences (7 guidelines).
Comparison
Outcome
Two sets of guidelines were elaborated by international organizations, the rest were produced by professional associations within high-resource countries. The discrepancies found in the guidelines were important and affected the definition of anaemia, the criteria for screening asymptomatic women, or the criteria guiding treatment. The quality of the guidelines commonly scored between 4 and 6 on a scale of 0 to 7. Recommendations with poor-quality evidence predominated over recommendations with high-quality evidence.
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Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis
Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gülmezoglu AM, et al
The Cochrane database of systematic reviews. 2020;11:Cd012754
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Editor's Choice
Abstract
BACKGROUND Postpartum haemorrhage (PPH), defined as a blood loss of 500 mL or more after birth, is the leading cause of maternal death worldwide. The World Health Organization (WHO) recommends that all women giving birth should receive a prophylactic uterotonic agent. Despite the routine administration of a uterotonic agent for prevention, PPH remains a common complication causing one-quarter of all maternal deaths globally. When prevention fails and PPH occurs, further administration of uterotonic agents as 'first-line' treatment is recommended. However, there is uncertainty about which uterotonic agent is best for the 'first-line' treatment of PPH. OBJECTIVES To identify the most effective uterotonic agent(s) with the least side-effects for PPH treatment, and generate a meaningful ranking among all available agents according to their relative effectiveness and side-effect profile. SEARCH METHODS We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (5 May 2020), and the reference lists of all retrieved studies. SELECTION CRITERIA All randomised controlled trials or cluster-randomised trials comparing the effectiveness and safety of uterotonic agents with other uterotonic agents for the treatment of PPH were eligible for inclusion. DATA COLLECTION AND ANALYSIS Two review authors independently assessed all trials for inclusion, extracted data and assessed each trial for risk of bias. Our primary outcomes were additional blood loss of 500 mL or more after recruitment to the trial until cessation of active bleeding and the composite outcome of maternal death or severe morbidity. Secondary outcomes included blood loss-related outcomes, morbidity outcomes, and patient-reported outcomes. We performed pairwise meta-analyses and indirect comparisons, where possible, but due to the limited number of included studies, we were unable to conduct the planned network meta-analysis. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS Seven trials, involving 3738 women in 10 countries, were included in this review. All trials were conducted in hospital settings. Randomised women gave birth vaginally, except in one small trial, where women gave birth either vaginally or by caesarean section. Across the seven trials (14 trial arms) the following agents were used: six trial arms used oxytocin alone; four trial arms used misoprostol plus oxytocin; three trial arms used misoprostol; one trial arm used Syntometrine® (oxytocin and ergometrine fixed-dose combination) plus oxytocin infusion. Pairwise meta-analysis of two trials (1787 participants), suggests that misoprostol, as first-line treatment uterotonic agent, probably increases the risk of blood transfusion (risk ratio (RR) 1.47, 95% confidence interval (CI) 1.02 to 2.14, moderate-certainty) compared with oxytocin. Low-certainty evidence suggests that misoprostol administration may increase the incidence of additional blood loss of 1000 mL or more (RR 2.57, 95% CI 1.00 to 6.64). The data comparing misoprostol with oxytocin is imprecise, with a wide range of treatment effects for the additional blood loss of 500 mL or more (RR 1.66, 95% CI 0.69 to 4.02, low-certainty), maternal death or severe morbidity (RR 1.98, 95% CI 0.36 to 10.72, low-certainty, based on one study n = 809 participants, as the second study had zero events), and the use of additional uterotonics (RR 1.30, 95% CI 0.57 to 2.94, low-certainty). The risk of side-effects may be increased with the use of misoprostol compared with oxytocin: vomiting (2 trials, 1787 participants, RR 2.47, 95% CI 1.37 to 4.47, high-certainty) and fever (2 trials, 1787 participants, RR 3.43, 95% CI 0.65 to 18.18, low-certainty). According to pairwise meta-analysis of four trials (1881 participants) generating high-certainty evidence, misoprostol plus oxytocin makes little or no difference to the use of additional uterotonics (RR 0.99, 95% CI 0.94 to 1.05) and to blood transfusion (RR 0.95, 95% CI 0.77 to 1.17) compared with oxytocin. We cannot rule out an important benefit of using the misoprostol plus oxytocin combination over oxytocin alone, for additional blood loss of 500 mL or more (RR 0.84, 95% CI 0.66 to 1.06, moderate-certainty). We also cannot rule out important benefits or harms for additional blood loss of 1000 mL or more (RR 0.76, 95% CI 0.43 to 1.34, moderate-certainty, 3 trials, 1814 participants, one study reported zero events), and maternal mortality or severe morbidity (RR 1.09, 95% CI 0.35 to 3.39, moderate-certainty). Misoprostol plus oxytocin increases the incidence of fever (4 trials, 1866 participants, RR 3.07, 95% CI 2.62 to 3.61, high-certainty), and vomiting (2 trials, 1482 participants, RR 1.85, 95% CI 1.16 to 2.95, high-certainty) compared with oxytocin alone. For all outcomes of interest, the available evidence on the misoprostol versus Syntometrine® plus oxytocin combination was of very low-certainty and these effects remain unclear. Although network meta-analysis was not performed, we were able to compare the misoprostol plus oxytocin combination with misoprostol alone through the common comparator of oxytocin. This indirect comparison suggests that the misoprostol plus oxytocin combination probably reduces the risk of blood transfusion (RR 0.65, 95% CI 0.42 to 0.99, moderate-certainty) and may reduce the risk of additional blood loss of 1000 mL or more (RR 0.30, 95% CI 0.10 to 0.89, low-certainty) compared with misoprostol alone. The combination makes little or no difference to vomiting (RR 0.75, 95% CI 0.35 to 1.59, high-certainty) compared with misoprostol alone. Misoprostol plus oxytocin compared to misoprostol alone are compatible with a wide range of treatment effects for additional blood loss of 500 mL or more (RR 0.51, 95% CI 0.20 to 1.26, low-certainty), maternal mortality or severe morbidity (RR 0.55, 95% CI 0.07 to 4.24, low-certainty), use of additional uterotonics (RR 0.76, 95% CI 0.33 to 1.73, low-certainty), and fever (RR 0.90, 95% CI 0.17 to 4.77, low-certainty). AUTHORS' CONCLUSIONS The available evidence suggests that oxytocin used as first-line treatment of PPH probably is more effective than misoprostol with less side-effects. Adding misoprostol to the conventional treatment of oxytocin probably makes little or no difference to effectiveness outcomes, and is also associated with more side-effects. The evidence for most uterotonic agents used as first-line treatment of PPH is limited, with no evidence found for commonly used agents, such as injectable prostaglandins, ergometrine, and Syntometrine®.
PICO Summary
Population
Women with postpartum haemorrhage (PPH), (7 studies, n= 3,738).
Intervention
Systematic review and network meta-analysis identifying the most effective uterotonic agent(s) for first-line PPH treatment with the least side-effects.
Comparison
Oxytocin alone; misoprostol plus oxytocin; misoprostol alone; and Syntometrine® (oxytocin and ergometrine fixed-dose combination) plus oxytocin infusion.
Outcome
Pairwise meta-analysis of two trials (n= 1,787), suggested that misoprostol, as first-line treatment uterotonic agent, probably increases the risk of blood transfusion compared with oxytocin. Low-certainty evidence suggested that misoprostol administration may increase the incidence of additional blood loss of 1,000 mL or more. The data comparing misoprostol with oxytocin was imprecise, with a wide range of treatment effects for the additional blood loss of 500 mL or more, maternal death or severe morbidity. The risk of side-effects may be increased with the use of misoprostol compared with oxytocin. According to pairwise meta-analysis of four trials (n= 1,881 participants) generating high-certainty evidence, misoprostol plus oxytocin made little or no difference to the use of additional uterotonics and to blood transfusion compared with oxytocin.
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Tranexamic acid in gynecologic surgery
Zakhari A, Sanders AP, Solnik MJ
Current medical research and opinion. 2019;:1
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Editor's Choice
Abstract
Objective: To review the mechanism of action, pharmacology, dosing, and complications of tranexamic acid (TXA) and consolidate current evidence for TXA in gynecologic surgery.Methods: A literature search of PubMed, Ovid (MEDLINE), Google Scholar, and Elsevier was performed, in addition to a targeted search of cited references involving TXA and gynecologic surgery. Preference was given to systematic reviews and randomized control trials (RCTs).Results: TXA reversibly binds to plasminogen, preventing clot degradation. RCTs on hysterectomy, myomectomy, cervical conisation, hysteroscopy, and surgery for cervical and ovarian cancer were identified, as were case reports on TXA use for ectopic pregnancy. During hysterectomy, TXA reduces blood loss (two RCTs, n = 432, mean difference -66.0mL and 180mL), blood transfusion (1 RCT, n = 100, 12% versus 42%, p < 0.00001). For myomectomy, a systematic review and meta-analysis showed a statistically significant decrease in blood loss with TXA (two RCTs, mean difference -213.1mL, 95% CI: -242.4mL to -183.7mL). Following cervical conisation, TXA decreased the risk of delayed hemorrhage (four RCTs, RR 0.23, 95% CI: 0.11 - 0.50). A single RCT for cervical and ovarian cancer surgery demonstrated a decrease mean blood loss of 120mL - 135mL and 210mL, respectively, and fewer blood transfusions for the latter (OR 0.44, upper 95% CI: 0.97, p = 0.02). Less robust data suggest a possible benefit from TXA during hysteroscopy and surgery for ectopic pregnancies. Most commonly, 1g of intravenous TXA is given intraoperatively.Conclusion: TXA is a safe adjunct that can be considered in a variety of gynecologic surgeries to decrease blood loss and risk of blood transfusion.
PICO Summary
Population
Patients undergoing gynaecologic surgery, (9 studies).
Intervention
Tranexamic acid (TXA) in various dosing regimens.
Comparison
Various comparators.
Outcome
During hysterectomy, TXA reduces blood loss (two RCTs, n = 432, mean difference -66.0mL and 180mL), blood transfusion (1 RCT, n = 100, 12% versus 42%). For myomectomy, a systematic review and meta-analysis showed a statistically significant decrease in blood loss with TXA (two RCTs, mean difference -213.1mL). Following cervical conisation, TXA decreased the risk of delayed hemorrhage (four RCTs, RR 0.23). A single RCT for cervical and ovarian cancer surgery demonstrated a decrease mean blood loss of 120mL - 135mL and 210mL, respectively, and fewer blood transfusions for the latter.
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Uterine Balloon Tamponade for the Treatment of Postpartum Hemorrhage: a Systematic Review and Meta-Analysis
Suarez S, Conde-Agudelo A, Borovac-Pinheiro A, Suarez-Rebling D, Eckardt M, Theron G, Burke TF
American journal of obstetrics and gynecology. 2019
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Editor's Choice
Abstract
OBJECTIVE To assess the efficacy, effectiveness, and safety of uterine balloon tamponade (UBT) for treating postpartum hemorrhage (PPH). DATA SOURCES Electronic databases from their inception to May 2019, and bibliographies. STUDY ELIGIBILITY CRITERIA Randomized controlled trials, non-randomized studies, and case series that reported on the efficacy, effectiveness, and/or safety of UBT in women with PPH. STUDY APPRAISAL AND SYNTHESIS METHODS The primary outcome was the success rate of UBT for treating PPH (number of UBT success cases/total number of women treated with UBT). For meta-analyses, we calculated pooled success rate for all studies, and relative risk (RR) with 95% confidence intervals (CIs) for studies that included a comparative arm. RESULTS Ninety-one studies, including 4,729 women, met inclusion criteria (6 randomized trials, 1 cluster randomized trial, 15 non-randomized studies, and 69 case series). The overall pooled UBT success rate was 85.9% (95% CI, 83.9-87.9). The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The UBT success rate was lower in cesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of two randomized trials that compared UBT versus no-UBT in PPH due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (RR 0.59, 95% CI 0.02-16.69). A meta-analysis of two non-randomized before-and-after studies showed that introduction of UBT in protocols for managing severe PPH significantly decreased the use of arterial embolization (RR 0.29, 95% CI 0.14-0.63). A non-randomized cluster study reported that use of invasive procedures was significantly lower in the perinatal network that routinely used UBT than that which did not use UBT (3.0/1000 vs 5.1/1000; p<0.01). A cluster randomized trial reported that the frequency of PPH-related invasive procedures and/or maternal death was significantly higher after UBT introduction than before UBT introduction (11.6/10,000 vs 6.7/10,000; p=0.04). Overall, the frequency of complications attributed to UBT use was low (≤6.5%). CONCLUSION UBT has a high success rate for treating severe PPH and appears to be safe. The evidence on UBT efficacy and effectiveness from randomized and non-randomized studies is conflicting, with experimental studies suggesting no beneficial effect in contrast with observational studies. Further research is needed to determine the most effective programmatic and health care delivery strategies on UBT introduction and use.
PICO Summary
Population
Women with post-partum haemorrhage, (91 studies, n=4,729).
Intervention
Systematic Review to assess the efficacy, effectiveness, and safety of uterine balloon tamponade for treating postpartum haemorrhage.
Comparison
Various Comparators.
Outcome
The overall pooled UBT success rate was 85.9%. The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The UBT success rate was lower in caesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of two randomiszed trials that compared UBT versus no-UBT in PPH due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (RR 0.59). A meta-analysis of two non-randomized before-and-after studies showed that introduction of UBT in protocols for managing severe PPH significantly decreased the use of arterial embolization (RR 0.29).
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10.
Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes
Rabe H, Gyte GM, Diaz-Rossello JL, Duley L
The Cochrane database of systematic reviews. 2019;9:Cd003248
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Editor's Choice
Abstract
BACKGROUND Infants born preterm (before 37 weeks' gestation) have poorer outcomes than infants at term, particularly if born before 32 weeks. Early cord clamping has been standard practice over many years, and enables quick transfer of the infant to neonatal care. Delayed clamping allows blood flow between the placenta, umbilical cord and baby to continue, and may aid transition. Keeping baby at the mother's side enables neonatal care with the cord intact and this, along with delayed clamping, may improve outcomes. Umbilical cord milking (UCM) is proposed for increasing placental transfusion when immediate care for the preterm baby is needed. This Cochrane Review is a further update of a review first published in 2004 and updated in 2012. OBJECTIVES To assess the effects on infants born at less than 37 weeks' gestation, and their mothers of: 1) delayed cord clamping (DCC) compared with early cord clamping (ECC) both with immediate neonatal care after cord clamping; 2) DCC with immediate neonatal care with cord intact compared with ECC with immediate neonatal care after cord clamping; 3) DCC with immediate neonatal care after cord clamping compared with UCM; 4) UCM compared with ECC with immediate neonatal care after cord clamping. SEARCH METHODS We searched the Cochrane Pregnancy and Childbirth Group Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (10 November 2017), and reference lists of retrieved studies. We updated the search in November 2018 and added nine new trial reports to the awaiting classification section to be assessed at the next update. SELECTION CRITERIA Randomised controlled trials (RCTs) comparing delayed with early clamping of the umbilical cord (with immediate neonatal care after cord clamping or with cord intact) and UCM for births before 37 weeks' gestation. Quasi-RCTs were excluded. DATA COLLECTION AND ANALYSIS Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Random-effects are used in all meta-analyses. Review authors assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS This update includes forty-eight studies, involving 5721 babies and their mothers, with data available from 40 studies involving 4884 babies and their mothers. Babies were between 24 and 36(+6) weeks' gestation at birth and multiple births were included. The data are mostly from high-income countries. Delayed clamping ranged between 30 to 180 seconds, with most studies delaying for 30 to 60 seconds. Early clamping was less than 30 seconds and often immediate. UCM was mostly before cord clamping but some were milked after cord clamping. We undertook subgroup analysis by gestation and type of intervention, and sensitivity analyses by low risk of selection and attrition bias.All studies were high risk for performance bias and many were unclear for other aspects of risk of bias. Certainty of the evidence using GRADE was mostly low, mainly due to imprecision and unclear risk of bias.Delayed cord clamping (DCC) versus early cord clamping (ECC) both with immediate neonatal care after cord clamping (25 studies, 3100 babies and their mothers)DCC probably reduces the number of babies who die before discharge compared with ECC (average risk ratio (aRR) 0.73, 95% confidence interval (CI) 0.54 to 0.98, 20 studies, 2680 babies (moderate certainty)).No studies reported on 'Death or neurodevelopmental impairment' in the early years'.DCC may make little or no difference to the number of babies with severe intraventricular haemorrhage (IVH grades 3 and 4) (aRR 0.94, 95% CI 0.63 to 1.39, 10 studies, 2058 babies, low certainty) but slightly reduces the number of babies with any grade IVH (aRR 0.83, 95% CI 0.70 to 0.99, 15 studies, 2333 babies, high certainty).DCC has little or no effect on chronic lung disease (CLD) (aRR 1.04, 95% CI 0.94 to 1.14, 6 studies, 1644 babies, high certainty).Due to insufficient data, we were unable to form conclusions regarding periventricular leukomalacia (PVL) (aRR 0.58, 95% CI 0.26 to 1.30, 4 studies, 1544 babies, low certainty) or maternal blood loss of 500 mL or greater (aRR 1.14, 95% CI 0.07 to 17.63, 2 studies, 180 women, very low certainty).We identified no important heterogeneity in subgroup or sensitivity analyses.Delayed cord clamping (DCC) with immediate neonatal care with cord intact versus early cord clamping (ECC) (one study, 276 babies and their mothers)There are insufficient data to be confident in our findings, but DCC with immediate neonatal care with cord intact may reduce the number of babies who die before discharge, although the data are also compatible with a slight increase in mortality, compared with ECC (aRR 0.47, 95% CI 0.20 to 1.11, 1 study, 270 babies, low certainty). DCC may also reduce the number of babies who die or have neurodevelopmental impairment in early years (aRR 0.61, 95% CI 0.39 to 0.96, 1 study, 218 babies, low certainty). There may be little or no difference in: severe IVH; all grades IVH; PVL; CLD; maternal blood loss ≥ 500 mL, assessed as low certainty mainly due to serious imprecision.Delayed cord clamping (DCC) with immediate neonatal care after cord clamping versus umbilical cord milking (UCM) (three studies, 322 babies and their mothers) and UCM versus early cord clamping (ECC) (11 studies, 1183 babies and their mothers)There are insufficient data for reliable conclusions about the comparative effects of UCM compared with delayed or early clamping (mostly low or very low certainty). AUTHORS' CONCLUSIONS Delayed, rather than early, cord clamping may reduce the risk of death before discharge for babies born preterm. There is insufficient evidence to show what duration of delay is best, one or several minutes, and therefore the optimum time to clamp the umbilical cord remains unclear. Whilst the current evidence supports not clamping the cord before 30 seconds at preterm births, future trials could compare different lengths of delay. Immediate neonatal care with the cord intact requires further study, and there are insufficient data on UCM.The nine new reports awaiting further classification may alter the conclusions of the review once assessed.
PICO Summary
Population
Mother and baby pairs where babies were born pre-term between 24 and 36+6 week gestation (n=5721, 48 studies).
Intervention
Delayed cord clamping (DCC).
Comparison
Early cord clamping (ECC).
Outcome
DCC probably reduces the number of babies who die before discharge compared with ECC (average risk ratio (aRR) 0.73, 95% confidence interval (moderate certainty)). No studies reported on 'Death or neurodevelopmental impairment' in the early years. DCC may make little or no difference to the number of babies with severe intraventricular haemorrhage (IVH grades 3 and 4) (aRR 0.94, 95% CI, low certainty) but slightly reduces the number of babies with any grade IVH (aRR 0.83, 95% CI high certainty).DCC has little or no effect on chronic lung disease (CLD) (aRR 1.04, 95% CI, high certainty). Due to insufficient data, we were unable to form conclusions regarding periventricular leukomalacia (PVL) or maternal blood loss of 500 mL or greater. We identified no important heterogeneity in subgroup or sensitivity analyses. There are insufficient data to be confident in our findings, but DCC with immediate neonatal care with cord intact may reduce the number of babies who die before discharge, although the data are also compatible with a slight increase in mortality, compared with ECC (aRR 0.47, 95% CI, low certainty). DCC may also reduce the number of babies who die or have neurodevelopmental impairment in early years (aRR 0.61, 95%, low certainty). There may be little or no difference in: severe IVH; all grades IVH; PVL; CLD; maternal blood loss >/= 500 mL, assessed as low certainty mainly due to serious imprecision. There are insufficient data for reliable conclusions about the comparative effects of umbilical cord milking (UCM) compared with delayed or early clamping (mostly low or very low certainty).