Project description:BACKGROUND: Postpartum haemorrhage remains an important cause of maternal death despite treatment with conventional therapy. Uncontrolled studies and one randomised comparison with conventional oxytocics have reported dramatic effects with high-dose misoprostol, usually given rectally, for treatment of postpartum haemorrhage, but this has not been evaluated in a placebo-controlled trial. METHODS: The study was conducted at East London Hospital Complex, Tembisa and Chris Hani Baragwanath Hospitals, South Africa. Routine active management of the third stage of labour was practised. Women with more than usual postpartum bleeding thought to be related to inadequate uterine contraction were invited to participate, and to sign informed consent. All routine treatment was given from a special 'Postpartum Haemorrhage Trolley'. In addition, participants who consented were enrolled by drawing the next in a series of randomised treatment packs containing either misoprostol 5 x 200 microg or similar placebo, which were given 1 orally, 2 sublingually and 2 rectally. RESULTS: With misoprostol there was a trend to reduced blood loss >/=500 ml in 1 hour after enrolment measured in a flat plastic 'fracture bedpan', the primary outcome (6/117 vs 11/120, relative risk 0.56; 95% confidence interval 0.21 to 1.46). There was no difference in mean blood loss or haemoglobin level on day 1 after birth < 6 g/dl or blood transfusion. Side-effects were increased, namely shivering (63/116 vs 30/118; 2.14, 1.50 to 3.04) and pyrexia > 38.5 degrees C (11/114 vs 2/118; 5.69, 1.29 to 25). In the misoprostol group 3 women underwent hysterectomy of whom 1 died, and there were 2 further maternal deaths. CONCLUSIONS: Because of a lower than expected incidence of the primary outcome in the placebo group, the study was underpowered. We could not confirm the dramatic effect of misoprostol reported in several unblinded studies, but the results do not exclude a clinically important effect. Larger studies are needed to assess substantive outcomes and risks before misoprostol enters routine use.

Project description: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.

Project description:BackgroundOf the 1010 reported maternal deaths in 2018, just over 65% occurred in hospitals in Ethiopia. However, there is a lack of standardised data about the contributing factors. This study aimed to investigate the incidence, mortality, and factors associated with primary postpartum haemorrhage following in-hospital births in northwest Ethiopia.MethodsA retrospective cohort design was used; an audit of 1060 maternity care logbooks of adult women post-partum at Felege Hiwot Referral Hospital and University of Gondar Comprehensive Specialized Hospital. The data were abstracted between December 2018 and May 2019 using a systematic random sampling technique. We used the Facility Based Maternal Death Abstraction Form containing sociodemographic characteristics, women's medical history, and partographs. Primary postpartum haemorrhage was defined as the estimated blood loss recorded by the staff greater or equal to 500 ml for vaginal births and 1000 ml for caesarean section births, or the medical doctor diagnosis and recording of the woman as having primary postpartum haemorrhage. The data analysis was undertaken using Stata version 15. Variables with P ≤ 0.10 for significance were selected to run multivariable logistic analyses. Variables that had associations with primary postpartum haemorrhage were identified based on the odds ratio, with 95% confidence interval (CI) and P-value less than 0.05.ResultsThe incidence of primary postpartum haemorrhage in the hospitals was 8.8% (95% CI: 7.2, 10.6). Of these, there were 7.4% (95% CI: 2.1, 13.3) maternal deaths. Eight predictor variables were found to be independently associated with primary postpartum haemorrhage, including age ≥35 years (AOR: 2.20; 95% CI: 1.08, 4.46; P = 0.03), longer than 24 hours duration of labour (AOR: 7.18; 95% CI: 2.73, 18.90; P = 0.01), vaginal or cervical lacerations (AOR: 4.95; 95% CI: 2.49, 9.86; P = 0.01), instrumental (forceps or vacuum)-assisted birth (AOR: 2.92; 95% CI: 1.25, 6.81; P = 0.01), retained placenta (AOR: 21.83; 95% CI: 6.33, 75.20; P = 0.01), antepartum haemorrhage in recent pregnancy (AOR: 6.90; 95% CI: 3.43, 13. 84; p = 0.01), women in labour referred from primary health centres (AOR: 2.48; 95% CI: 1.39, 4.42; P = 0.02), and births managed by medical interns (AOR: 2.90; 95% CI: 1.55, 5.37; P = 0.01).ConclusionWe found that while the incidence of primary postpartum haemorrhage appeared to be lower than in other studies in Africa the associated maternal mortality was higher. Although most factors associated with primary postpartum haemorrhage were consistent with those identified in the literature, two additional specific factors, were found to be prevalent among women in Ethiopia; the factors were referred women in labour from primary health facilities and births managed by medical interns. Maternal healthcare providers in these hospitals require training on the management of a birthing emergency.

Project description:ObjectiveTo assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis.DesignA cluster-randomised non-inferiority community trial.SettingHealth sub-centres and home deliveries in the Bijapur district of Karnataka, India.PopulationWomen with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study.MethodsAuxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.Main outcome measuresPostpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention.ResultsMisoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference -2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).ConclusionSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.Tweetable abstractSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis.

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Antifibrinolytic drugs for treating primary postpartum haemorrhage.

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