RESUMO
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 X2 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.
RESUMO
BACKGROUND: Despite the availability of effective antihypertensive drugs, the quality of evidence regarding the best antihypertensive agent for the treatment of hypertensive emergencies in pregnancy is still poor. AIM: The aim of this study was to compare the efficacy and side effects of oral nifedipine and intravenous hydralazine for control of blood pressure (BP) in severe hypertension in pregnancy. MATERIALS AND METHODS: An open-label, parallel, randomised, controlled trial of 78 pregnant women (≥28 weeks' gestation) with severe hypertension was conducted. Severe hypertension was defined as systolic BP of 160 mmHg or above and/or diastolic BP of 110 mmHg or above. They were randomly (1:1 ratio) administered oral nifedipine 20 mg or intravenous hydralazine 10 mg every 30 min up to 5 doses or until the target BP of 140-150 mmHg systolic and 90-100 mmHg diastolic was achieved. Intravenous labetalol was given if the primary treatment failed. The primary outcome measure was the number of doses needed to achieve targeted BP. The secondary outcome measures were the time needed to achieve desired BP, maternal adverse effects and perinatal outcome. RESULTS: The sociodemographic characteristics did not differ between the two study groups. The average number of dosages (nifedipine; 1.4 ± 0.6 vs. hydralazine; 1.7 ± 0.5, P = 0.008) needed to control the BP was lower in the nifedipine arm. Time (min) taken to control the BP was similar between the groups (hydralazine; 43.7 ± 19.7 vs. nifedipine; 51.2 ± 18.9, P = 0.113). Adverse maternal and perinatal effects did not differ in the study groups. CONCLUSION: Oral nifedipine and intravenous hydralazine showed comparable efficacy in the BP control in the severe hypertensive disorders of pregnancy without significant difference in adverse maternal and perinatal outcomes. However, further studies are required to explore the role of these drugs in BP control during hypertensive emergencies in pregnancy. CLINICALTRIALS.GOV: (Identification number: NCT04435210).
