Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial.

BACKGROUND: Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. OBJECTIVE: This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. STUDY DESIGN: The study is a double-blind randomized controlled trial. METHODS: The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. RESULTS: The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. CONCLUSION: Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363.

Active versus expectant management for premature rupture of membranes at term: A randomized, controlled study.

OBJECTIVE: To compare the effects on feto-maternal outcomes of expectant versus active management for premature rupture of membranes (PROM) at term. METHODS: This was a prospective randomized (1:1) controlled study involving 86 pregnant-women who received either expectant management (n = 43) or active management with misoprostol (n = 43) for PROM at term. Primary outcome was route of delivery. Secondary outcomes were: PROM to presentation interval; latency period; PROM to delivery interval; recruitment to delivery interval; labour and delivery complications. RESULTS: Baseline-characteristics were similar between groups. There was no significant difference between active and expectant groups in mean PROM to presentation/admission, or PROM to delivery. However, mean latency period (11.1 ± 7.3 hours vs 8.8 ± 5.5 hours) and mean recruitment to delivery intervals after PROM (14.7 ± 5.2 hours vs 11.8 ± 5.0 hours) were significantly shorter for the active group compared with the expectant group. Although the rate of caesarean section was less in expectant management group (21%) compared with the active management group (30%), the difference was not statistically significant. There were no significant differences between groups in delivery or perinatal complications. CONCLUSION: Active and expectant management for PROM at term gave comparable outcomes in terms of methods of delivery and complications. However, active management significantly shortened the latency period and induction to delivery intervals compared with expectant management.Trial-Registration: Pan-African-trial-registry-(PACTR)-approval-number PACTR202206797734088.