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 ...
Background: During pregnancy, amniotic fluid indicates the normal placental function. It is the most essential element for surveillance of fetal growth and health. Amniotic fluid index (AFI) is the most ideal way to determine the level of amniotic fluid during pregnancy. However, the single deepest pocket is applied to determine the changes in AFI level in pregnancies suspected to oligohydramnios. Borderline AFI is defined as AFI levels > 5 to < 10cm; it is a challenging task in obstetrics to associate it with adverse pregnancy outcomes. Objective: To assess the perinatal outcomes in patients with borderline AFI. Study Design: Cross-sectional. Setting: Department of Obstetrics & Gynaecology, Sharif Medical City Hospital, Lahore. Study Duration: Study was carried out over a period of six months from 10-11-2020 to 11-05-2021. Subjects And Methods: A total of 160 patients having borderline AFI (more than 5 and less than 10cm) were included in the study. Perinatal outcomes were assessed at the time of delivery in the hospital. Data Analysis Method: Stratification of data was carried out with regard to age, gestational age, parity and area of residence. Results: Mean age of the patients was 25.17±4.90 years. Mean gestational age was observed to be 38.44±1.54 weeks. Majority of the patients were between Para 0 to 3. There was no smoker in preset study. Most of the patients belonged to rural area. Perinatal outcomes were as follows: Intrapartum fetal distress was observed in 64 (40%), meconium staining in 56 (35%), Apgar score < 10 at 5 minutes in 37 patients (23.1%) and NICU admission in 38 (23.8%). Conclusion: In conclusion, borderline AFI during pregnancy can lead to severe hazardous consequences. Therefore, pregnancy complicated with borderline AFI must be observed carefully in order to improve the outcome of pregnancy and avoid adverse perinatal outcomes. Keywords: Borderline AFI, Apgar Score, NICU Admission, Intrapartum Fetal Distress, Meconium Staining.
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