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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
Ortuanya, K. E., Eleje, G. U., Ezugwu, F. O., Odugu, B. U., Ikechebelu, J. I., Ugwu, E. O., Eke, A. C., Awkadigwe, F. I., Ezenwaeze, M. N., Ofor, I. J., et al
Women's health (London, England). 2024;20:17455057231225311
Abstract
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.
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Efficacy of Tranexamic Acid in Reducing Myomectomy-Associated Blood Loss among Patients with Uterine Myomas at Federal Teaching Hospital Abakaliki: A Randomized Control Trial
Olaleye, A. A., Adebayo, J. A., Eze, J. N., Ajah, L. O., Anikwe, C. C., Egede, J. O., Ebere, C. I.
International journal of reproductive medicine. 2024;2024:2794052
Abstract
BACKGROUND Myomectomy can be associated with life-threatening conditions such as bleeding. Excessive bleeding usually necessitates blood transfusion. Interventions to reduce bleeding during myomectomy will help reduce the need for blood transfusion with its associated complications. Tranexamic acid has been used to reduce bleeding in other surgical procedures, and its usage during myomectomy merits evaluation. OBJECTIVE To assess the efficacy of tranexamic acid in reducing myomectomy-associated blood loss. MATERIALS AND METHODS This is a prospective double-blinded randomized trial conducted on women who had abdominal myomectomy. Patients were randomized into two groups. The study group received perioperative intravenous tranexamic acid (TXA) while the control group received a placebo. Intraoperative blood loss was calculated by measuring the volume in the suction apparatus and weighing the surgical swabs. In addition, blood collected postoperatively from the wound drains and drapes were measured. Haemoglobin concentrations were determined preoperatively and on second postoperative day for all cases. Any adverse effect was noted in both groups. The data was processed using Epi Info software (7.2.1, CDC, Atlanta, Georgia). The relationships between categorical data were analyzed using X(2) and Student's t-test to determine relationships between continuous variables, with a P value of 0.05 considered statistically significant, and correlation coefficients were calculated using Pearson's formula, and probability of 0.05 was set for statistical significance. RESULTS Symptomatic uterine myomas constituted 17.3% of all gynaecological admissions and 21.3% of gynaecological operations at Federal Teaching Hospital Abakaliki. The mean intraoperative blood loss among patients that had perioperative tranexamic acid infusion was 413.6 ± 165.6 ml, while that of patients with placebo infusion was 713.6 ± 236.3 ml. Perioperative tranexamic acid infusion therefore reduced mean intraoperative blood loss by 300 ml, and this was statistically significant (SMD = -0.212, 95% CI: -403.932 to -196.067, P < 0.0001). Perioperative tranexamic acid reduced mean total blood loss by a value of 532.3 ml, and this is statistically significant (SMD = 30.622, 95% CI: 393.308 to 670.624, P < 0.0001). Tranexamic acid also improved postoperative haemoglobin concentration by 1.8 g/dl compared with placebo, and this is statistically significant (SMD = -0.122, 95% CI: 1.182 to 2.473, P < 0.0001). Tranexamic acid infusion decreased hospital stay by about 2 days, and this difference was statistically significant (SMD = -3.929, 95% CI: -3.018 to -0.983, P = 0.0003). There was no adverse drug reaction in the course of the study. CONCLUSION The use of tranexamic acid during myomectomy reduced intraoperative and postoperative blood loss. It is also associated with decreased hospital stay. This trial is registered with NCT04560465.
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Tranexamic acid to reduce blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery-a randomized controlled trial
Neumann, B. G., Metgud, M. C., Hoffman, M. K., Patil, K., Savanur, M., Hanji, V., Ganachari, M. S., Somannavar, M., Goudar, S. S.
AJOG global reports. 2024;4(1):100316
Abstract
BACKGROUND Postpartum hemorrhage is a leading cause of maternal morbidity and mortality. Tranexamic acid has proven to be useful in treating hemorrhage from acute blood loss. However, its role in preventing blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery is not well studied. OBJECTIVE This study aimed to assess the role of tranexamic acid in reducing blood loss during elective and unscheduled cesarean deliveries in women at high risk of postpartum hemorrhage. STUDY DESIGN This was a prospective, placebo-controlled, randomized controlled trial from March 2021 to February 2022 at the Karnatak Lingayat Education Society Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, India. Women at a high risk of postpartum hemorrhage undergoing cesarean delivery were recruited and randomized to receive either tranexamic acid or placebo (1:1) at least 10 minutes before skin incision. High-risk factors for postpartum hemorrhage included obesity, hypertension, multiparity, previous cesarean delivery, multiple pregnancy, abnormally implanted placenta, placenta previa, abruption, uterine leiomyomas, polyhydramnios, and fetal macrosomia. The primary outcome was blood loss, calculated by a formula using pre- and postoperative hematocrit levels. In addition, gravimetrically measured blood loss was measured and compared between the 2 groups. RESULTS A total of 212 women met the inclusion criteria and were randomized (tranexamic acid [n=106] and placebo [n=106]). The mean blood loss estimates were 400.9 mL in the tranexamic acid group and 597.9 mL in the placebo group (P<.001). The mean gravimetrically measured blood loss estimates were 379.2 mL in the tranexamic acid group and 431.1 mL in the placebo group (P<.001). In addition, there was a significant difference in the fall in hemoglobin levels (1.04 vs 1.61 g/dL) and change in hematocrit levels (3.20% vs 4.95%) from the pre- to postoperative period between the 2 groups (P<.001). No difference in the need for additional uterotonics (P=.26) or the need for postoperative parental iron (P=.18) was noted. No woman was transfused in either group. CONCLUSION High-risk women receiving tranexamic acid had significantly less blood loss than women receiving placebo during cesarean delivery.
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To Study the Efficacy and Safety of Diosmin with Tranexamic Acid and Mefenamic Acid Versus only Tranexamic Acid and Mefenamic Acid in Medical Management of Abnormal Uterine Bleeding: A Randomized Controlled Trial
Sharma, J. B., Kumari, R., Kumari, S., Jain, S., Dharmendra, S.
Journal of mid-life health. 2023;14(2):87-93
Abstract
BACKGROUND Abnormal uterine bleeding (AUB) is a common problem in reproductive age group and perimenopausal age group being responsible for many outpatient visits. Traditional management of AUB consists of giving mefenamic acid, tranexamic acid, or their combination with progestogens or hormonal intrauterine deviced levonorgestrel intrauterine system (LNG-IUS) for severe or nonresponsive cases. The objective of the current study was to study the efficacy and safety of adding diosmin along with tranexamic acid and mefenamic acid in reducing menstrual blood loss in AUB patients. MATERIALS AND METHODS It was a prospective double-blind randomized controlled trial in which 900 mg of diosmin was given once daily along with 500 mg tranexamic acid and 250 mg mefenamic acid during menstruation (Group I-92 patients), or only tranexamic acid and mefenamic acid during menstruation (Group II-92 patients). RESULTS Mean age, parity, body mass index, and socioeconomic status were similar in the two groups. It was 35.68 years versus 36.78 years, 2.2 versus 2.3, 23.68 kg/m(2) versus 24.62 kg/m(2) respectively. Mean days of bleeding before this treatment were 6.8 versus 6.6 (P = 0.33) and were 3.5 versus 5.2 (P = 0.02) after treatment. There was a significant reduction in both groups as compared to before treatment (P = 0.021 in Group I, 0.027 in Group II) but the reduction was greater in Group I (P = 0.02). The amount of blood loss was 385 ml versus 390 ml (P = 0.7) before treatment which was significantly reduced in both groups to 68 ml versus 112 ml (P = 0.02 in Group I, 0.03 in Group II) with more decrease in Group I than in Group II (P = 0.01). Mean hemoglobin at beginning of the study was 8.4 versus 8.5 g/dl in Group I and Group II (P = 0.02) and significantly increased in both groups posttreatment to 10.9 and 9.8 g/dl in Group I and Group II (P = 0.012 in Group I, 0.011 in Group II) with increase being more in Group I than Group II (P = 0.03). Pictorial blood assessment chart score was 398 versus 406 (P = 0.35) before treatment and decreased significantly to 86.5 and 110.5 (P = 0.001 in Group I, 0.001 in Group II) with more decrease being in Group I than II (P = 0.01). There was significant decrease in dysmenorrhea with both treatments with no difference in the two groups. Various adverse effects such as nausea, vomiting, abdominal pain, diarrhea, constipation, and headache were equal in the two groups. CONCLUSION Both the group's diosmin with tranexamic acid and mefenamic acid (Group I) and tranexamic acid and mefenamic acid (Group II) were efficacious in reducing menstrual blood loss, number of menstrual days and dysmenorrhea with effect being more by addition of diosmin. Adverse effects were equal in both the two groups.
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Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery
Pacheco LD, Clifton RG, Saade GR, Weiner SJ, Parry S, Thorp JM Jr, Longo M, Salazar A, Dalton W, Tita ATN, et al
The New England journal of medicine. 2023;388(15):1365-1375
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Abstract
BACKGROUND Prophylactic use of tranexamic acid at the time of cesarean delivery has been shown to decrease the calculated blood loss, but the effect on the need for blood transfusions is unclear. METHODS We randomly assigned patients undergoing cesarean delivery at 31 U.S. hospitals to receive either tranexamic acid or placebo after umbilical-cord clamping. The primary outcome was a composite of maternal death or blood transfusion by hospital discharge or 7 days post partum, whichever came first. Key secondary outcomes were estimated intraoperative blood loss of more than 1 liter (prespecified as a major secondary outcome), interventions for bleeding and related complications, the preoperative-to-postoperative change in the hemoglobin level, and postpartum infectious complications. Adverse events were assessed. RESULTS A total of 11,000 participants underwent randomization (5529 to the tranexamic acid group and 5471 to the placebo group); scheduled cesarean delivery accounted for 50.1% and 49.2% of the deliveries in the respective groups. A primary-outcome event occurred in 201 of 5525 participants (3.6%) in the tranexamic acid group and in 233 of 5470 (4.3%) in the placebo group (adjusted relative risk, 0.89; 95.26% confidence interval [CI], 0.74 to 1.07; P = 0.19). Estimated intraoperative blood loss of more than 1 liter occurred in 7.3% of the participants in the tranexamic acid group and in 8.0% of those in the placebo group (relative risk, 0.91; 95% CI, 0.79 to 1.05). Interventions for bleeding complications occurred in 16.1% of the participants in the tranexamic acid group and in 18.0% of those in the placebo group (relative risk, 0.90; 95% CI, 0.82 to 0.97); the change in the hemoglobin level was -1.8 g per deciliter and -1.9 g per deciliter, respectively (mean difference, -0.1 g per deciliter; 95% CI, -0.2 to -0.1); and postpartum infectious complications occurred in 3.2% and 2.5% of the participants, respectively (relative risk, 1.28; 95% CI, 1.02 to 1.61). The frequencies of thromboembolic events and other adverse events were similar in the two groups. CONCLUSIONS Prophylactic use of tranexamic acid during cesarean delivery did not lead to a significantly lower risk of a composite outcome of maternal death or blood transfusion than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT03364491.).
PICO Summary
Population
Patients undergoing caesarean delivery at 31 U.S. hospitals (n= 11,000).
Intervention
Tranexamic acid (n= 5,529).
Comparison
Placebo (n= 5,471).
Outcome
The primary outcome was a composite of maternal death or blood transfusion by hospital discharge or 7 days postpartum, whichever came first. A primary-outcome event occurred in 201 of 5,525 participants (3.6%) in the tranexamic acid group and in 233 of 5,470 (4.3%) in the placebo group (adjusted relative risk, 0.89; 95.26% CI [0.74, 1.07]). Estimated intraoperative blood loss of more than 1 litre occurred in 7.3% of the participants in the tranexamic acid group and in 8.0% of those in the placebo group (relative risk, 0.91; 95% CI [0.79, 1.05]). Interventions for bleeding complications occurred in 16.1% of the participants in the tranexamic acid group and in 18.0% of those in the placebo group (relative risk, 0.90; 95% CI [0.82, 0.97]); the change in the haemoglobin level was -1.8 g per decilitre and -1.9 g per decilitre, respectively (mean difference, -0.1 g per decilitre; 95% CI [-0.2, -0.1]); and postpartum infectious complications occurred in 3.2% and 2.5% of the participants, respectively (relative risk, 1.28; 95% CI [1.02, 1.61]). The frequencies of thromboembolic events and other adverse events were similar in the two groups.
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Intravenous tranexamic acid vs. sublingual misoprostol in high-risk women for postpartum haemorrhage following cesarean delivery; a randomised clinical trial
Dawoud, M., Al-Husseiny, M., Helal, O., Elsherbini, M., Abdel-Rasheed, M., Sediek, M.
BMC pregnancy and childbirth. 2023;23(1):611
Abstract
OBJECTIVE This study compares the effectiveness of administering sublingual misoprostol combined with oxytocin to that of IV tranexamic acid combined with oxytocin to reduce intra and post-operative blood loss in high-risk women for postpartum haemorrhage (PPH) following cesarean section (CS). METHODS About 315 high-risk pregnant women undergoing CS participated in this trial. They were randomly assigned into three groups; tranexamic group, misoprostol group, and control group, according to the medication given in the operative theatre. All patients received oxytocin intraoperatively. They were assessed regarding intraoperative blood loss, the incidence of PPH, and the reduction in haemoglobin and hematocrit values. RESULTS Both tranexamic and misoprostol groups had similar results in reducing intra and post-operative blood loss. However, the reduction in haemoglobin and hematocrit were significantly lower in tranexamic and misoprostol groups compared to the control group (-0.78 ± 0.57 vs. -0.83 ± 0.52 vs. -1.32 ± 0.57 gm/dl, P < 0.001 and - 3.05 ± 1.28 vs. -3.06 ± 1.13 vs. -4.94 ± 1.82%, P < 0.001 respectively). In addition, the estimated blood loss was significantly lower in the tranexamic and misoprostol groups compared to the control group (641.6 ± 271.9 vs. 617.9 ± 207.4 vs. 1002.4 ± 340.7 ml, P < 0.001). CONCLUSION Both tranexamic acid and misoprostol are equally capable of reducing blood loss, but the results were significantly better compared to using oxytocin alone in high-risk patients. CLINICAL TRIAL REGISTRATION Registered at www. CLINICALTRIALS govon07/10/2019 with registration number NCT04117243.
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Intraoperative use of tranexamic acid to reduce blood loss during cytoreductive surgery for advanced ovarian cancer: A randomized controlled clinical trial
Yang X, Chai M, Xia L, He Z, Wu X, Zhang J
Acta obstetricia et gynecologica Scandinavica. 2023
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Abstract
INTRODUCTION Tranexamic acid reduces blood loss and allogeneic transfusion requirements in various surgical procedures. The role of tranexamic acid during cytoreductive procedures in advanced ovarian cancer is not clear. MATERIAL AND METHODS This was a single center randomized, controlled, three-armed clinical trial. A total of 150 ovarian cancer patients undergoing cytoreductive surgery were recruited and assigned to three groups (n = 50/group): the control group (normal saline), low-dose group (10 mg/kg bolus + 1 mg/kg continuous infusion of tranexamic acid), and high-dose group (20 mg/kg bolus + 5 mg/kg continuous infusion of tranexamic acid). The primary endpoint was intraoperative blood loss volume and total blood loss volume, and secondary endpoints included intraoperative blood transfusion volumes, vasoactive agent consumption, admission into the intensive care unit, and incidence of postoperative complications within postoperative 30 days. The study was registered at ClinicalTrials.gov ID: NCT04360629. RESULTS The patients in the high-dose group had less intraoperative (median [IQR]: 625.3 mL [343.5-1210.5]) and total blood loss volume (748.9 mL [292.2-1650.2]) than those in the control group (1015.5 mL [679.4-1015.5], p = 0.012; and 1700.7 mL [458.7-2419.8], p = 0.004, respectively). In contrast, the intraoperative (992.5 mL [539.0-1404.0], p = 0.874) and total blood loss volume (1025.0 mL [381.8-1819.9], p = 0.113) was not significantly reduced in the low-dose group when compared with the control group. Correspondingly, the relative risk of blood transfusion (RR [95% CI], 0.405 [0.180-0.909], p = 0.028) was reduced in the high-dose group and required less intraoperative noradrenaline (881.0 ± 438.3 mg) to maintain stable hemodynamics than the control group (1548.0 ± 349.8 mg, p = 0.001). Furthermore, compared with the control group, the two tranexamic acid groups had decreased intensive care unit admission rates (p = 0.016) without increasing the incidence of postoperative seizure, acute kidney injury, and thromboembolism. CONCLUSIONS High-dose tranexamic acid is more effective in reducing blood loss and blood transfusion without increasing the risk of postoperative complications. The high-dose regime tended to have a better risk-benefit profile.
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Oxytocin versus a combination of tranexamic acid and ethamsylate in reducing intraoperative bleeding during abdominal myomectomy: a randomized clinical trial
Abdou, A. M., Eldesouky, E., Farag, E., Mohammed, A., Abdelaziz, D. F. M., Shaaban, A., Ellaban, M., Elhalim, Aema, Elsror, A. G. A., Marai, A. A. E., et al
BMC women's health. 2023;23(1):398
Abstract
OBJECTIVE Myomectomy is the preferred surgical approach to manage uterine fibroids. However, uterine fibroids are highly vascular tumors and, consequently, extremely susceptible to problems from myomectomy-related hemorrhage. Hence, we aim to compare oxytocin efficacy and safety profile versus tranexamic acid (TA) with ethamsylate for reducing bleeding during myomectomy. METHODS This randomized, double-blinded multicenter study was performed between 20(th) August 2020 and 20(th) October 2020 at El-Galaa Teaching Hospital, El Hussein University Hospital, Al-Azhar University Hospitals of Assiut, and Al-Azhar University Hospitals of Damietta. One hundred and eighty patients were enrolled and divided into three groups: group (1) received an injection of 30 IU of oxytocin in 500 ml of normal saline; group (2) received injections of 1 g of TA, 250 mg of Ethamsylate, and 110 ml of normal saline IV; and group (3) received an injection of 110 ml of normal saline IV just before surgical incision. RESULTS In 180 premenopausal women, oxytocin and TA with ethamsylate had no significant value in lowering intraoperative blood loss compared with the placebo for abdominal myomectomy (666.25 ± 183.03, 630.72 ± 145.83, and 646.67 ± 168.92, respectively (P = 0.506)). Non-significant trends were observed for a reduction in operation time (P = 0.760), intra/postoperative blood transfusion (P = 0.624), hospital stay (P = 0.986), postoperative fever (P = 0.659), and wound infection (P = 1). CONCLUSION Oxytocin and TA with ethamsylate had no significant value in lowering intraoperative blood loss compared with the placebo for abdominal myomectomy which opens a new question about the role of the use of the hemostatic drug during myomectomy especially in centers with limited resources and had higher rates. TRIAL REGISTRATION The study was registered on Pan African Clinical Trials Registry with the following number: PACTR202008739887429 and was approved on 24/08/2020.
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Role of tranexamic acid-soaked gelatin sponge in minimizing rectus sheath hematoma after cesarean section in women treated with warfarin, a simple tool for high-risk cases, a randomized controlled trial
Hany, A., Mansour, A., Sediek, M., Nabil, M.
European journal of medical research. 2023;28(1):448
Abstract
BACKGROUND This study aims to illustrate the impact of applying the tranexamic acid impregnated in a gelatin sponge between the anterior rectus sheath and the Rectus Abdominis muscle during Cesarean section (CS) in minimizing rectus sheath hematoma (RHS) in women treated with Warfarin. METHODS A clinical trial was carried out on 63 pregnant women attended for elective CS, who on antenatal warfarin anticoagulation started from 13 weeks gestation to 36 weeks then shifted to low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH), and with an indication for postnatal warfarin anticoagulation. They were randomly assigned on the day of the scheduled CS into three equal groups (21 women for each). Group 1 had two pieces of gelatin sponges soaked with one ampoule of tranexamic acid. Group 2 had two pieces of gelatin sponges not soaked with tranexamic acid. Group 3 (control group) had no gelatin sponge applied. All patients underwent postoperative assessment done for hemoglobin (Hb), hematocrit (HCT), estimated blood loss (EBL), amount and nature of discharge collected from the sub-rectus drain, complications (RHS, wound infection, thromboembolism), need for re-operation, and need for blood transfusion. RESULTS Statistically significant differences were found between Group 1 and Group 2 regarding the postoperative Hb (10.66 ± 1.13 vs. 9.77 ± 0.69, P = 0.009), between Group 1 and Group 2 regarding the postoperative HCT (31.87 ± 3.59 vs. 28.54 ± 1.85, P = 0.001), between Group 1 and Group 2 regarding EBL (442.19 ± 244.46 vs. 744.38 ± 267.05, P = 0.003), between Group 1 and Group 3 regarding EBL (442.19 ± 244.46 vs. 664.29 ± 343.97, P = 0.040), and between Group 1 and Group 3 regarding the discharge amount from the sub rectus drain (190.48 ± 100.77 vs. 307.14 ± 127.76, P = 0.004). CONCLUSION Tranexamic acid-soaked gelatin sponges are safe and effective in reducing postoperative drainage and EBL. CLINICAL TRIAL REGISTRATION At ClinicalTrials.gov in June 2022 (NCT05439694).
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Maternal anaemia and the risk of postpartum haemorrhage: a cohort analysis of data from the WOMAN-2 trial
The Lancet. Global health. 2023
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Editor's Choice
Abstract
BACKGROUND Worldwide, more than half a billion women of reproductive age are anaemic. Each year, about 70 000 women who give birth die from postpartum haemorrhage. Almost all deaths are in low-income or middle-income countries. We examined the association between anaemia and the risk of postpartum haemorrhage. METHODS We did a prospective cohort analysis of data from the World Maternal Antifibrinolytic-2 (WOMAN-2) trial. This trial enrols women with moderate or severe anaemia giving birth vaginally in hospitals in Pakistan, Nigeria, Tanzania, and Zambia. Hospitals in each country where anaemia in pregnancy is common were identified from a network established during previous obstetric trials. Women who were younger than 18 years without permission provided by a guardian, had a known tranexamic acid allergy, or developed postpartum haemorrhage before the umbilical cord was cut or clamped were excluded from the study. Prebirth haemoglobin, the exposure, was measured after hospital arrival and just before giving birth. Postpartum haemorrhage, the outcome, was defined in three ways: (1) clinical postpartum haemorrhage (estimated blood loss ≥500 mL or any blood loss sufficient to compromise haemodynamic stability); (2) WHO-defined postpartum haemorrhage (estimated blood loss of at least 500 mL); and (3) calculated postpartum haemorrhage (calculated estimated blood loss of ≥1000 mL). Calculated postpartum haemorrhage was estimated from the peripartum change in haemoglobin concentration and bodyweight. We used multivariable logistic regression to examine the association between haemoglobin and postpartum haemorrhage, adjusting for confounding factors. FINDINGS Of the 10 620 women recruited to the WOMAN-2 trial between Aug 24, 2019, and Nov 1, 2022, 10 561 (99·4%) had complete outcome data. 8751 (82·9%) of 10 561 women were recruited from hospitals in Pakistan, 837 (7·9%) from hospitals in Nigeria, 525 (5·0%) from hospitals in Tanzania, and 448 (4·2%) from hospitals in Zambia. The mean age was 27·1 years (SD 5·5) and mean prebirth haemoglobin was 80·7 g/L (11·8). Mean estimated blood loss was 301 mL (SD 183) for the 8791 (83·2%) women with moderate anaemia and 340 mL (288) for the 1770 (16·8%) women with severe anaemia. 742 (7·0%) women had clinical postpartum haemorrhage. The risk of clinical postpartum haemorrhage was 6·2% in women with moderate anaemia and 11·2% in women with severe anaemia. A 10 g/L reduction in prebirth haemoglobin increased the odds of clinical postpartum haemorrhage (adjusted odds ratio [aOR] 1·29 [95% CI 1·21-1·38]), WHO-defined postpartum haemorrhage (aOR 1·25 [1·16-1·36]), and calculated postpartum haemorrhage (aOR 1·23 [1·14-1·32]). 14 women died and 68 either died or had a near miss. Severe anaemia was associated with seven times higher odds of death or near miss (OR 7·25 [95% CI 4·45-11·80]) than was moderate anaemia. INTERPRETATION Anaemia is strongly associated with postpartum haemorrhage and the risk of death or near miss. Attention should be given to the prevention and treatment of anaemia in women of reproductive age. FUNDING The WOMAN-2 trial is funded by Wellcome and the Bill & Melinda Gates Foundation.
PICO Summary
Population
Women with moderate or severe anaemia giving birth vaginally in hospitals, enrolled in the WOMAN-2 trial in Pakistan, Nigeria, Tanzania, and Zambia (n= 10,620).
Intervention
This prospective cohort analysis of data from the WOMAN-2 trial examined the association between anaemia and the risk of postpartum haemorrhage.
Comparison
Outcome
Postpartum haemorrhage was defined in three ways: clinical postpartum haemorrhage; WHO-defined postpartum haemorrhage; and calculated postpartum haemorrhage. There was complete outcome data for 10,561 participants. Mean estimated blood loss was 301 mL (SD= 183) for the 8,791 (83.2%) women with moderate anaemia and 340 mL (288) for the 1,770 (16.8%) women with severe anaemia. 742 (7.0%) women had clinical postpartum haemorrhage. The risk of clinical postpartum haemorrhage was 6.2% in women with moderate anaemia and 11.2% in women with severe anaemia. A 10 g/L reduction in prebirth haemoglobin increased the odds of clinical postpartum haemorrhage (adjusted odds ratio (aOR)= 1.29; 95% CI [1.21, 1.38]), WHO-defined postpartum haemorrhage (aOR= 1.25; 95% CI [1.16, 1.36]), and calculated postpartum haemorrhage (aOR= 1.23; 95% CI [1.14, 1.32]). 14 women died and 68 either died or had a near miss. Severe anaemia was associated with seven times higher odds of death or near miss (OR= 7.25; 95% CI [4.45, 11.80]) than was moderate anaemia.