Single- versus multiple-unit transfusion in hemodynamically stable postpartum anemia: a pragmatic randomized, controlled trial
Am J Obstet Gynecol. 2020
BACKGROUND The American Academy of Blood Banks recommends single-unit red cell transfusion protocols across medicine to reduce transfusion complications and use of a scarce resource. There is minimal data regarding single-unit protocols within obstetrics. OBJECTIVE We aimed to compare a single- vs. multiple-unit transfusion protocol for treatment of hemodynamically stable postpartum anemia. STUDY DESIGN We performed a randomized trial comparing initial transfusion with 1 unit of packed red blood cells [pRBCs] (single-unit protocol) to 2 units of pRBCs (multiple-unit protocol) from 3/2018-7/2019. Postpartum women >6 hours from delivery who required transfusion were approached for consent. Unstable vital signs, hemoglobin(Hb)< 5g/dL, hemoglobinopathy, and cardiomyopathy were enrollment exclusions. Hemoglobin assessment and standardized clinical evaluation were performed 4-6 hours post-transfusion; additional pRBCs were given if indicated. The primary outcome was total units transfused. Secondary outcomes include length of stay, endometritis, wound separation/infection, venous thromboembolism, and intensive care unit admission within 30 days postpartum. Breastfeeding, depression, maternal attachment, and fatigue scores were assessed at 4-9 weeks postpartum. 66 women were required to detect a 20% reduction in units transfused with a single-unit protocol (power=80%; alpha=0.05). RESULTS 66 women were randomized (33/arm). There were no differences between groups in demographic or clinical characteristics, including delivery mode, blood loss, and randomization Hb. Mean number of units transfused was lower in the single- compared to the multiple-unit protocol (1.2u vs. 2.1u, p< 0.001). Only 18.2% of women in the single-unit arm required additional pRBCs. At post-transfusion assessment, women in the single-unit arm had lower Hb (7.8g/dL vs. 8.7g/dL, p< 0.001), but there were no differences in vital signs or symptoms between groups. There were also no differences in length of stay, 30-day complications, or 4-9 week postpartum outcomes. CONCLUSION In women with hemodynamically stable postpartum anemia, a single-unit protocol avoids a second unit of pRBCs in >80% of women without significant impact on morbidity. Our work supports use of single-unit initial transfusion in this population.
Haemodynamically stable postpartum women requiring blood transfusion in a single US centre (n= 66).
1 unit of packed red blood cells (pRBCs), (single-unit protocol, n= 33).
2 units of pRBCs (multiple-unit protocol, n= 33).
There were no differences between groups in demographic or clinical characteristics, including delivery mode, blood loss, and randomization Hb. Mean number of units transfused was lower in the single- compared to the multiple-unit protocol (1.2u vs. 2.1u). Only 18.2% of women in the single-unit arm required additional pRBCs. At post-transfusion assessment, women in the single-unit arm had lower Hb (7.8g/dL vs. 8.7g/dL), but there were no differences in vital signs or symptoms between groups. There were also no differences in length of stay, 30-day complications, or 4-9 week postpartum outcomes.
Intraoperative cell salvage for obstetrics: a prospective randomized controlled clinical trial
BMC pregnancy and childbirth. 2020;20(1):452
BACKGROUND The latest basic studies and clinical evidence have confirmed the safety and efficacy of intraoperative autologous blood cell transfusion in cardiac surgery and orthopaedics. However, in caesarean section, there are still concerns about the contamination of amniotic fluid and foetal components, and consequently the application of intraoperative autologous blood cell transfusion is not universal. Therefore, this study aimed to evaluate the clinical value of intraoperative autologous blood cell transfusion in obstetric surgery. METHODS A prospective, randomized, controlled, feasibility study was performed in women undergoing caesarean section. One hundred sixteen participants were randomly assigned at a 1:1 ratio into either the intraoperative cell salvage group or the control group. Allogeneic blood cells were transfused into patients with haemoglobin concentrations < 80 g/dL in both the intraoperative cell salvage group and the control group. RESULTS No significant differences were found between the two groups in age, weight, maternal parity, history of previous caesarean section, gestational weeks of delivery, etc. However, compared with the control group, patients in the intraoperative cell salvage group had a significantly lower amount of allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay. CONCLUSION The results of this study suggest that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. TRIAL REGISTRATION All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee of Beijing Obstetrics and Gynecology Hospital, Capital Medical University (2016-XJS-003-01) as well as the 1964 Helsinki Declaration and its later amendments or other comparable ethical standards. The clinical trials were registered (ChiCTR-ICC-15,007,096) on September 28, 2015.
Women undergoing caesarean section (n= 116).
Intraoperative cell salvage (n= 58).
Control group, allogeneic red blood cell infusion when the haemoglobin concentration was < 80 g/L (n= 58).
Patients in the intraoperative cell salvage group had a significantly lower amount of allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay.
Pure red-cell aplasia secondary to pregnancy: Case report and review of the literature
Revista colombiana de obstetricia y ginecologia. 2020;71(4):365-373
OBJECTIVE To report a case of pure red-cell aplasia secondary to pregnancy and to conduct a review of the literature regarding diagnosis and treatment, as well as maternal and perinatal prognosis. METHODS This is the case of a 24-year-old patient at 34 weeks of gestation, referred to a regional public referral hospital due to anemia. Bone marrow biopsy was performed, leading to the diagnosis of pregnancy-related pure red-cell aplasia. The patient received serial red blood cell transfusions. Delivery by Cesarean section at term resulted in a healthy newborn. Hemoglobin values remained stable during the postoperative period. A literature search was conducted in Medline via PubMed, LILACS, SciELO and ScienceDirect using the terms "pregnancy" and "pure red-cell aplasia". Case reports, case series and literature reviews in English and Spanish published between January 1999 and January 2020 that report pregnant women with pure red-cell aplasia were included. Information on diagnosis, treatment and maternal and perinatal prognosis was collected. Three of the authors selected the studies by title and abstract; A descriptive synthesis is provided. RESULTS Overall, 828 titles were identified; of these,818 were discarded after reviewing the inclusions criteria. Ten articles were included: six case reports, three case reports with literature review, and one case report in the poster modality, for a total number of 10 reported cases. Diagnosis was based on low hemoglobin levels and compromised erythroid cell line in bone marrow biopsy. Treatment consists of red blood cell transfusions, with good maternal and fetal prognosis. CONCLUSIONS Diagnosis of pure red-cell aplasia during pregnancy requires bone marrow biopsy. With transfusion support, maternal perinatal prognosis is good. Further studies are required to assess the safety and efficacy of steroid use in this pregnancy-related condition.
A Regression Model for Prediction of Cesarean-Associated Blood Transfusion
American journal of perinatology. 2019
OBJECTIVE To develop a model to predict cesarean-associated red blood cell transfusion. STUDY DESIGN Secondary analysis of all cesarean deliveries in the Maternal-Fetal Medicine Units Network Cesarean Registry. Using a split-sample technique, the derivation group was used to identify associated factors and build predictive models, and the validation group was used to estimate classification errors and determine test characteristics. Using factors available at the time of cesarean, we developed a multivariable logistic regression prediction model. RESULTS A total of 59,468 women were split evenly and randomly into the derivation and validation groups. The overall rate of transfusion was 2.7%. The area under the receiver operating characteristic curve for the derivation and validation groups were 0.82 (95% confidence interval [CI]: 0.80-0.84) and 0.84 (95% CI: 0.82-0.85), respectively (p = 0.16). The strongest predictors of transfusion were placenta previa (odds ratio [OR]: 7.06, 95% CI: 5.19-9.61) and eclampsia/Hemolysis Elevated Liver Enzymes Low Platelets syndrome (OR: 5.67, 95% CI: 3.77-8.51). In the validation group, the model had a sensitivity, specificity, positive, and negative predictive values of 55.8, 91.5, 16.2, and 98.6%, respectively. Overall, 90.5% of patients were correctly classified. CONCLUSION A regression model incorporating variables available at the time of cesarean accurately predicts the need for intra- or postoperative transfusion.
Patient blood management (PBM) in pregnancy and childbirth: literature review and expert opinion
Archives of gynecology and obstetrics. 2019
PURPOSE Patient blood management [PBM] has been acknowledged and successfully introduced in a wide range of medical specialities, where blood transfusions are an important issue, including anaesthesiology, orthopaedic surgery, cardiac surgery, or traumatology. Although pregnancy and obstetrics have been recognized as a major field of potential haemorrhage and necessity of blood transfusions, there is still little awareness among obstetricians regarding the importance of PBM in this area. This review, therefore, summarizes the importance of PBM in obstetrics and the current evidence on this topic. METHOD We review the current literature and summarize the current evidence of PBM in pregnant women and postpartum with a focus on postpartum haemorrhage (PPH) using PubMed as literature source. The literature was reviewed and analysed and conclusions were made by the Swiss PBM in obstetrics working group of experts in a consensus meeting. RESULTS PBM comprises a series of measures to maintain an adequate haemoglobin level, improve haemostasis and reduce bleeding, aiming to improve patient outcomes. Despite the fact that the WHO has recommended PBM early 2010, the majority of hospitals are in need of guidelines to apply PBM in daily practice. PBM demonstrated a reduction in morbidity, mortality, and costs for patients undergoing surgery or medical interventions with a high bleeding potential. All pregnant women have a significant risk for PPH. Risk factors do exist; however, 60% of women who experience PPH do not have a pre-existing risk factor. Patient blood management in obstetrics must, therefore, not only be focused on women with identified risk factor for PPH, but on all pregnant women. Due to the risk of PPH, which is inherent to every pregnancy, PBM is of particular importance in obstetrics. Although so far, there is no clear guideline how to implement PBM in obstetrics, there are some simple, effective measures to reduce anaemia and the necessity of transfusions in women giving birth and thereby improving clinical outcome and avoiding complications. CONCLUSION PBM in obstetrics is based on three main pillars: diagnostic and/or therapeutic interventions during pregnancy, during delivery and in the postpartum phase. These three main pillars should be kept in mind by all professionals taking care of pregnant women, including obstetricians, general practitioners, midwifes, and anaesthesiologists, to improve pregnancy outcome and optimize resources.
Intrauterine administration of autologous peripheral blood mononuclear cells in patients with recurrent implantation failure: A systematic review and meta-analysis
Journal of reproductive immunology. 2019;131:50-56
Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC) has been proposed to improve implantation rates in women with recurrent implantation failure (RIF). The objective of this study was to evaluate whether intrauterine administration of PBMC improves clinical pregnancy and live birth in couples with RIF. Various databases were searched including Medline, Embase, Scopus, Web of Science and Cochrane Central Register of Controlled Trials up to April 2018. This review included all studies that compared intervention of PBMC in infertile women undergoing any form of assisted reproductive technology (ART). Two independent reviewers assessed eligibility; methodological quality; and extracted data. Meta-analysis using a random-effects model was performed to calculate the pooled estimates. Eight studies involving 886 patients were included. The probability of clinical pregnancy was significantly higher in women who received PBMC compared with control (RR: 1.92, 95% CI: 1.48-2.49; P < 0.001). No difference was observed in the studies that transmitted the embryo at blastocyst (RR: 2.44, 95% CI: 1.42-4.20; P = 0.001), or cleavage stage (RR: 2.01, 95% CI: 1.36-2.96; P < 0.001). There was no difference between studies that transmitted the embryo in fresh (RR: 2.14, 95% CI: 1.38-3.32; P < 0.001), or frozen condition (RR: 1.79, 95% CI: 1.32-2.43; P < 0.001). The probability of live birth was significantly higher in women who received PBMC compared with control (RR: 1.93, 95% CI: 1.35-2.76; P < 0.001). Administration of PBMC, irrespective of embryo stage and cycle type, increases clinical pregnancy and live birth in patients experienced RIF. However, these overall estimates should be considered with caution due to the small number, quasi-experimental design and poor quality of most included studies.
Blood adiponectin concentration at birth in small for gestational age neonates: A meta-analysis
Diabetes & metabolic syndrome. 2019;13(1):183-188
AIMS: Small for gestational age (SGA) is associated with increased rates of neonatal mortality and morbidity. Adiponectin secreted from adipose tissue is implicated in the etiology of death and illness during infancy. SGA is also a likely risk factor for the development of metabolic and clinical complications in adulthood. The present study was performed to determine whether SGA neonates and healthy controls show differences in blood adiponectin concentration at birth. METHODS Databases were searched to identify English-language studies providing the numbers of SGA neonates, the numbers of healthy controls, and the means and standard deviations (SDs) of blood adiponectin concentrations at birth in both groups. Study quality was assessed using the Newcastle-Ottawa Scale (NOS). A meta-analysis was performed to summarize the standardized mean differences (SMDs) in blood adiponectin concentration between SGA neonates and healthy controls. RESULTS The results summarized from five good quality (i.e., NOS score≥5) studies involving 253 neonates showed that blood adiponectin concentration was significantly lower in SGA neonates than in healthy controls (P=0.016), and the effect was moderate (i.e., SMD=0.4-0.7). CONCLUSIONS Synthetic evidence indicated that blood adiponectin concentration at birth is lower in SGA neonates than in healthy controls.
Efficacy of intrauterine administration of autologous peripheral blood mononuclear cells on the pregnancy outcomes in patients with recurrent implantation failure: A systematic review and meta-analysis
Journal of reproductive immunology. 2019;137:103077
One in every nine couples suffers from implantation defects and pregnancy failures. In spite of many contributions that ART has given to infertility treatment, there are many reports of the failure of ART. Therefore, scientists suggested many complementary therapies for use besides ART to improve the quality of infertility treatments. Intrauterine PBMC-therapy is one of these complementary therapies that were used before IVF. Studies that examined PBMC treatment in women with at least three IVF/ET failure were included in this review. These studies involved RCT and quasi-experimental (non-randomized experimental) studies. A three-step search strategy was used for published and unpublished clinical trials written in English and Persian. No time limitation was set for studies. Study selection according to the inclusion criteria and methodological quality assessment and data extraction were done by two independent reviewers, which result in five studies being included (two RCTs and three quasi-experimental studies). Finally, all of these article extracted data were pooled in a statistical meta-analysis. Findings demonstrated that implantation, pregnancy and live birth rate were statistically increased and the miscarriage rate was significantly decreased in the PBMC-treated group than that non-treated group. In conclusion, based on the evidence, PBMCs can be an effective therapeutic approach in women with at least three IVF/ET failure and lacking initial inflammation that is essential for implantation.
Effect of withholding feeds on transfusion related acute gut injury in preterm infants - a pilot randomized controlled trial
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians. 2019;:1-161
BACKGROUND Several retrospective studies have reported an increase in necrotizing enterocolitis (NEC) during the 48 hours following red blood cell (RBC) transfusion. Whether withholding enteral feeding during transfusion decreases the risk of transfusion-associated acute gut injury (TRAGI) in preterm infants is unclear. STUDY DESIGN AND METHODS In this pilot study, 112 preterm infants with gestational age ≤ 32 weeks and/or birth weight ≤ 1500 grams were randomly assigned to withholding (NPO) or continuance of feeding (FED) during RBC transfusion. Primary outcome measure was development of NEC (stage ≥ 2) within 72 hours of a transfusion and the change in abdominal circumference. RESULTS One hundred fifty-four transfusion episodes (74 NPO and 80 FED) were analyzed. Demographic characteristics were found to be similar in both groups. There was no difference in rates of NEC (0 versus 3.4%; p = 0.49) between the NPO and FED groups. The incidence of feeding intolerance was higher in the FED group however it was statistically insignificant (1.9 versus 6.8%, p = 0.36). Abdominal circumference remained similar in both groups in all three consecutive days following transfusion (p > 0.05). CONCLUSION This pilot study does not support withholding feedings during transfusion but is not adequately powered to test the hypothesis that NPO decreases NEC rates. Adequately powered well designed multicenter trials are still required.
Packed red cells versus whole blood transfusion for severe paediatric anaemia, pregnancy-related anaemia and obstetric bleeding: an analysis of clinical practice guidelines from sub-Saharan Africa and evidence underpinning recommendations
Tropical Medicine & International Health : Tm & Ih. 2018;24((1):):11-22.
OBJECTIVE Blood component transfusion is increasingly promoted in sub-Saharan Africa (SSA), but is resource-intensive so whole blood is often used. We examined SSA recommendations about whole blood and packed red cell transfusions for pregnancy-related bleeding or anaemia, and paediatric anaemia, and evaluated the evidence underpinning these recommendations. METHOD Relevant SSA guidelines were identified using five electronic databases, websites for SSA Ministries of Health, blood transfusion services and WHO. To facilitate comparisons, indications for transfusing packed red cells or whole blood within these guidelines and reasons given for these recommendations were recorded on a pre-designed matrix. The AGREE II tool was used to appraise guidelines that gave a reason for recommending either packed red cells or whole blood. We systematically searched MEDLINE, CINAHL, Global Health, Cochrane library and NHSBT Transfusion Evidence Library, using PRISMA guidelines, for clinical studies comparing whole blood with packed red cells or combined blood components in obstetric bleeding or anaemia, or paediatric anaemia. Characteristics and findings of included studies were extracted in a standardised format and narratively summarised. RESULTS 32 English language guidelines from 15 SSA countries mentioned packed red cell or whole blood use for our conditions of interest. Only seven guidelines justified their recommendation for using packed red cells or whole blood. No recommendations or justifications had supporting citations to research evidence. 33 full-text papers, from 11,234 citations, were reviewed but only one study met our inclusion criteria. This was a single-centre study in post-partum haemorrhage. CONCLUSION Evidence comparing whole blood and packed red cell transfusion for common paediatric and maternal indications is virtually absent in SSA. Therefore, it is unclear whether policies promoting red cells over whole blood transfusion are clinically appropriate. Building a relevant evidence base will help develop effective policies promoting the most appropriate use of blood in African settings. This article is protected by copyright. All rights reserved.