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Background Peripartum hysterectomy can cause significant morbidity and mortality. Most studies of peripartum hysterectomy are from high income countries. This cohort study examined risk factors for peripartum hysterectomy using data from Africa, Asia, Europe and the Americas. Methods We used data from the World Maternal Antifibrinolytic (WOMAN) trial carried out in 193 hospitals in 21 countries. Peripartum hysterectomy was defined as hysterectomy within 6 weeks of delivery as a complication of postpartum haemorrhage. Univariable and multivariable random effects logistic regression models were used to analyse risk factors. A hierarchical conceptual framework guided our multivariable analysis. Results Five percent of women had a hysterectomy (1020/20,017). Haemorrhage from placenta praevia/accreta carried a higher risk of hysterectomy (17%) than surgical trauma/tears (5%) and uterine atony (3%). The adjusted odds ratio (AOR) for hysterectomy in women with placenta praevia/accreta was 3.2 (95% CI: 2.7–3.8), compared to uterine atony. The risk of hysterectomy increased with maternal age. Caesarean section was associated with fourfold higher odds of hysterectomy than vaginal delivery (AOR 4.3, 95% CI: 3.6–5.0). Mothers in Asia had a higher hysterectomy incidence (7%) than mothers in Africa (5%) (AOR: 1.2, 95% CI: 0.9–1.7). Conclusions Placenta praevia/accreta is associated with a higher risk of peripartum hysterectomy. Other risk factors for hysterectomy are advanced maternal age, caesarean section and giving birth in Asia.

Background Each year, worldwide about 530,000 women die from causes related to pregnancy and childbirth. Of the deaths 99% are in low and middle income countries. Obstetric haemorrhage is the leading cause of maternal mortality, most occurring in the postpartum period. Systemic antifibrinolytic agents are widely used in surgery to prevent clot breakdown (fibrinolysis) in order to reduce surgical blood loss. At present there is little reliable evidence from randomised trials on the effectiveness of tranexamic acid in the treatment of postpartum haemorrhage. Methods The Trial aims to determine the effect of early administration of tranexamic acid on mortality, hysterectomy and other morbidities (surgical interventions, blood transfusion, risk of non-fatal vascular events) in women with clinically diagnosed postpartum haemorrhage. The use of health services and safety, especially thromboembolic effect, on breastfed babies will also be assessed. The trial will be a large, pragmatic, randomised, double blind, placebo controlled trial among 15,000 women with a clinical diagnosis of postpartum haemorrhage. All legally adult women with clinically diagnosed postpartum haemorrhage following vaginal delivery of a baby or caesarean section will potentially be eligible. The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage. Treatment will entail a dose of tranexamic acid (1 gram by intravenous injection) or placebo (sodium chloride 0.9%) will be given as soon as possible after randomisation. A second dose may be given if after 30 minutes bleeding continues, or if it stops and restarts within 24 hours after the first dose. The main analyses will be on an 'intention to treat' basis, irrespective of whether the allocated treatment was received or not. Subgroup analyses for the primary outcome will be based on type of delivery; administration or not of prophylactic uterotonics; and on whether the clinical decision to consider trial entry was based primarily on estimated blood loss alone or on haemodynamic instability. A study with 15,000 women will have over 90% power to detect a 25% reduction from 4% to 3% in the primary endpoint of mortality or hysterectomy. Trial registration Current Controlled Trials: ISRCTN76912190 and Clinicaltrials.gov ID: NCT00872469

Placenta accreta spectrum (PAS), or morbidly adherent placenta, is a life-threatening condition requiring caesarean section (C-section) and often hysterectomy due to massive postpartum haemorrhage. The widely adopted conservative management—the Triple-P procedure—carries a risk of substantial blood loss. Modifications like blunt bladder dissection and haemostatic suturing can help control bleeding however, bladder injury remains a concern, as identifying vesicouterine planes can be difficult among placental and prior C-sections adhesions. While some studies have used Cystoinflation (retrograde bladder filling) to delineate bladder edges in complex C-sections, its efficacy in preventing bladder injury during PAS surgeries is inconclusive, and no trial has evaluated its integration with the Modified Triple-P technique. To address this gap, we conducted a single-centre, single-blinded controlled trial with 150 women with PAS confirmed during C-section. Participants were randomised to either Modified Triple-P alone or the combined approach with Cystoinflation. Bladder injury, the primary outcome, occurred in 2 (2.7%) of the Cystoinflation group versus 14 (18.7%) of the controls ( P  < .0001). Secondary outcomes, including blood loss, hysterectomy rates, urologic complications, neonatal outcomes, and fertility, also favoured the combined approach. These results suggest adding Cystoinflation to Modified Triple-P enhances bladder safety and optimises maternal and foetal outcomes in PAS management. Trial registration This trial is a part of project “Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery” with ethical approval from King Edward Medical University. Trial Registration NCT04302545.

Introduction Considering the effective treatment of postpartum hemorrhage, intrauterine balloon tamponed can apply pressure from the inside of the uterus, and uterine compression suture can apply pressure from the outside of the uterus. Although combining the two methods can enhance the effectiveness of hemostasis, there is a paucity of studies reporting on outcome. The aim of this study was to report a surgical protocol for postpartum hemorrhage by intrauterine balloon tamponing combined with mid-section loop ligation and its subsequent effects on the uterus. Materials and methods Medical records was conducted to identify pregnancies complicated by postpartum hemorrhage following cesarean section, which occurred at a single hospital between February 2021 and May 2022. This study involved the comparison and correlation of surgical duration, hemorrhage loss, blood loss, perioperative outcomes, hospital stay, and uterine recovery. Results A total of 74 pregnancies were analyzed, with 30 cases assigned to the study group, which received intrauterine balloon tamponade combined with mid-section loop ligation, and 44 cases assigned to the control group, which received intrauterine balloon tamponade alone. The loop ligation group demonstrated a significant advantage over the control group in terms of shorter duration of surgery and reduced postoperative bleeding. Conclusion The addition of mid-section loop ligation enhances the hemostatic efficacy of intrauterine balloon tamponade, resulting in a shorter procedural duration. This combined technique offers a novel approach to managing postpartum hemorrhage.

Background In severe post-partum haemorrhage, death can occur within hours of bleeding onset so interventions to control the bleeding must be given immediately. In clinical trials of treatments for life-threatening bleeding, established treatments are given priority and the trial treatment is usually given last. However, enrolling patients in whom severe maternal morbidity or death is imminent or inevitable at the time of randomisation may dilute the effects of a trial treatment. Methods We conducted an exploratory analysis of data from the WOMAN trial, an international, randomised placebo-controlled trial of the effects of tranexamic acid on death and surgical intervention in 20,060 women with post-partum haemorrhage. We assessed the impact of early maternal death or hysterectomy due to exsanguination on the effect of tranexamic acid on each of these respective outcomes. We conducted repeated analyses excluding patients with these outcomes at increasing intervals from the time of randomisation. We quantified treatment effects using risk ratios (RR) and 99% confidence intervals (CI) and prepared cumulative failure plots. Results Among 14,923 women randomised within 3 h of delivery (7518 tranexamic acid and 7405 placebo), there were 216 bleeding deaths (1.5%) and 383 hysterectomies due to bleeding (2.8%). After excluding deaths from exsanguination at increasing time intervals following randomization, there was a significant reduction in the risk of death due to bleeding with tranexamic acid (RR = 0.41; 99% CI 0.19–0.89). However, after excluding hysterectomies at increasing time intervals post-randomization, there was no reduction in the risk of hysterectomy due to bleeding with tranexamic acid (RR = 0.79; 99% CI 0.33–1.86). Conclusions Findings from this analysis provide further evidence that tranexamic acid reduces the risk of death from exsanguination in women who experience postpartum haemorrhage. It is uncertain whether tranexamic acid reduces the risk of hysterectomy for bleeding after excluding early hysterectomies. Trial registration ISRCTN trial registration number ISRCTN76912190, 8 Dec 2008; ClinicalTrials.gov number NCT00872469, 30 March 2009; PACTR number PACTR201007000192283, 9 Feb 2010; EudraCT number 2008–008441-38, 8 Dec 2010 (retrospectively registered).

To compare the efficacy of dexmedetomidine and midazolam in the prevention of postoperative nausea and vomiting (PONV) caused by hemabate in postpartum hemorrhage during cesarean delivery. One hundred and five parturients with American Society of Anesthesiology (ASA) physical status I and II, aged 20-40 years, undergoing elective cesarean delivery under epidural anesthesia were randomly allocated into dexmedetomidine group (group D, n=35), midazolam group (group M, n=35) and control group (group C, n=35). Patients received an intrauterine injection of 250 μg hemabate and continuous intravenous infusion of 5 units oxytocin immediately following the delivery of the infant. At the same time, patients in group D received 1μg/kg intravenous dexmedetomidine, group M received 0.02 mg/kg intravenous midazolam and group C received 20 mL intravenous saline. Parameters such as the PONV, other adverse reactions (chest distress, flush, etc.) caused by hemabate, patient satisfaction, the sedation (OAA/S) scores, and the hemodynamic parameters were recorded in both groups. The PONV incidence in group D and group M was significantly lower compared with group C (6%, 17%, and 71% for group D, group M, and group C, respectively, P<0.05). The sedation (OAA/S) scores in group D and group M was significantly higher compared with group C (1.62±0.28, 1.75±0.31, and 1.00±0.00 for group D, group M, and group C, respectively, P<0.05). The patient satisfaction in group D and group M was significantly higher compared with group C (94%, 69%, and 46% for group D, group M, and group C, respectively, P<0.05). Furthermore, there were more patients satisfied with group D than group M (94% vs.69%, P<0.05). Intravenous dexmedetomidine (1 μg/kg) and midazolam (0.02 mg/kg) were equally effective in preventing PONV introduced by hemabate and dexmedetomidine is superior to midazolam in patient satisfaction.

Background Severe haemorrhage is a leading cause of maternal death worldwide. Most haemorrhage deaths occur soon after childbirth. Severe post-partum bleeding is sometimes managed by the surgical removal of the uterus (hysterectomy). Death and hysterectomy are important health consequences of post-partum haemorrhage, and clinical trials of interventions aimed at preventing these outcomes are needed. Methods The World Maternal Antifibrinolytic trial aims to determine the effect of tranexamic acid on death, hysterectomy and other health outcomes in women with post-partum haemorrhage. It is an international, multicentre, randomised trial. Approximately 20,000 women with post-partum haemorrhage will be randomly allocated to receive an intravenous injection of either tranexamic acid or matching placebo in addition to usual care. The primary outcome measure is a composite of death in hospital or hysterectomy within 42 days of delivery. The cause of death will be described. Secondary outcomes include death, death due to bleeding, hysterectomy, thromboembolic events, blood transfusion, surgical and radiological interventions, complications, adverse events and quality of life. The health status and occurrence of thromboembolic events in breastfed babies will also be reported. We will conduct subgroup analyses for the primary outcome by time to treatment, type of delivery and cause of haemorrhage. We will conduct an analysis of treatment effect adjusted for baseline risk. Discussion The World Maternal Antifibrinolytic trial should provide reliable evidence for the efficacy of tranexamic acid in the prevention of death, hysterectomy and other outcomes that are important to patients. We present a protocol update and the statistical analysis plan for the trial. Trial registration Current Controlled Trials ISRCTN76912190 (Registration date 08 December 2008), Clinicaltrials.gov NCT00872469 (Registration date 30 March 2009) and Pan African Clinical Trials Registry: PACTR201007000192283 (Registration date 02 September 2010).

Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage. In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283. Between March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus placebo group. Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset. London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation.

To assess the effectiveness of the new modified technique in order to control bleeding in women presenting with atonic, flabby uterus compared to the most commonly described technique of classic B-Lynch suture. This study included 160 women of uncontrolled atonic postpartum hemorrhage delivered by cesarean section at Ain Shams University Maternity Hospital between January 2013 and October 2015. Participants were randomly assigned following simple randomization procedures (computerized random numbers) and divided into two groups. Group, I (80 patients) operated upon by the modified (new technique) stitch while group II (80 patients) operated upon by the classic technique. The ultimate goals were to stop blood loss after placement of the sutures and avoid life-saving hysterectomy thus preserving the life and fertility of the patient. The modified new technique was done in 80 patients with atonic postpartum hemorrhage and it was found to be superior to the classic technique with a success rate 95 % (4 cases needed hysterectomy as a lifesaving measure) compared to 85 % with the classic technique (in 12 cases, a life-saving hysterectomy was done). This technique can replace the classic B-lynch in flabby unresponsive atonic uteri as it has 8 shaped placement of the stitch which causes more firm compression on the uterus and simultaneous bilateral uterine artery ligation. This technique was proved valuable and successful in many patients who suffer from uncontrolled massive postpartum hemorrhage (PPH).

Introduction A peripartum hysterectomy is typically performed as a lifesaving procedure in obstetrics to manage severe postpartum hemorrhage. Severe hemorrhages that lead to peripartum hysterectomies are mainly caused by uterine atony and placenta accreta spectrum disorders. In this study, we aimed to estimate the incidence, risk factors, causes and management of severe postpartum hemorrhage resulting in peripartum hysterectomies, and to describe the complications of the hysterectomies. Material and methods Eligible women had given birth at gestational week 23+0 or later and had a postpartum hemorrhage ≥1500 mL or a blood transfusion, due to postpartum hemorrhage, at Oslo University Hospital, Norway, between 2008 and 2017. Among the eligible women, this study included those who underwent a hysterectomy within the first 42 days after delivery. The Norwegian Medical Birth Registry provided the reference group. We used Poisson regression to estimate adjusted incidence rate ratios with 95% confidence intervals to identify clinical factors associated with peripartum hysterectomy. Results The incidence of hysterectomies with severe postpartum hemorrhage was 0.44/1000 deliveries (42/96313). Among the women with severe postpartum hemorrhage, 1.6% ended up with a hysterectomy (42/2621). Maternal age ≥40, previous cesarean section, multiple pregnancy and placenta previa were associated with a significantly higher risk of hysterectomy. Placenta accreta spectrum disorders were the most frequent cause of hemorrhage that resulted in a hysterectomy (52%, 22/42) and contributed to most of the complications following the hysterectomy (11/15 women with complications). Conclusions The rate of peripartum hysterectomies at Oslo University Hospital was low, but was higher than previously reported from Norway. Risk factors included high maternal age, previous cesarean section, multiple pregnancy and placenta previa, well known risk factors for placenta accreta spectrum disorders and severe postpartum hemorrhage. Placenta accreta spectrum disorders were the largest contributor to hysterectomies and complications.