SummaryBackgroundPost-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.MethodsIn 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.FindingsBetween 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 ...
Objectives: A study done in Omdurman Maternity Hospital (OMH) during 2013, to study the effect of corticosteroid administration two days before an elective caesarean section to reduce the respiratory morbidity in infants born. Methodology:It is a randomized control trial study comparing prophylactic antenatal corticosteroids with no treatment given before elective caesarean section C/S.Results: A total of 560 patients of 5421 who underwent elective caesarean section C/S in 2013, were randomly selected, 281 (50.2%) were treated by 12 mg dexamethasone, two doses 12 hours apart, and 279 (49.8%) were in the control group. 26 infants were admitted to nursery there were 8 new-borns from the treatment group, and 18 from control group, with regards to indication of admission; those who had Respiratory distress (RDS) in the control group were 6 (2.2%),and in the treatment group were 2(0.7%), Transient tachypnea of the newborn( TTN) in the control group were 12 (4.3%), in the treatment group were 6(2.2%), (P value 0.00), (RR: 0.6 for TTN & 0.25 for RDS). Stay in special babies care unit (SBCU)<24 hours were 6 (2.2%) in control group and 8 (2.8%) in the treatment group, stay>24 hours were 12 (4.3%) in the control group and zero in the treatment, (P value was 0.026). 3 (1.1%) needed assisted ventilation, one death found in the control group (0.4%). Conclusion:Giving dexamethasone, two before elective C/S had a significant reduction in the respiratory morbidity and decrease hospital study. It has no adverse effect and can be safely used.
Objectives: -This is a descriptive, cross-sectional study, done in Khartoum state to assess patients and providers' knowledge and practice on informed consent in obstetrics and gynecology operations during year 2009. Methodology:-After an informed consent from patients and hospital directorate, data was collected by interview of both patients and health care providers at department of obstetrics and gynecology in all Khartoum state hospitals, during the period from first of January to 31 st of December 2009.Results: -In this study, 544 patients and 393 health care providers were included. Informed consent is known to be important to 355 (90.3%) of health care providers, its contents are wholly or partially known to 263 (66.9%). It was taken for surgical operation by 298 (75.8%) of providers, it was written in 279/ 298 (93.6%) and verbal in 19 /298 (06.4%). Written consent was signed by the husband, the patient herself or her relatives. Lack of time and language are the main reasons for, not taking an informed consent. Conclusion: -Although informed consent is relatively implemented; its requirements were not properly fulfilled. Not taking an informed consent is influenced by multifactorial barriers including lack of time, language and lack of experience. Pre and in-service training on informed consent and communication skills, with detailed format of informed consent will improve the situation.
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