Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial

Abstract

BackgroundPostpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Estimates of its incidence in the literature vary widely, from 3 % to 15 % of deliveries. Uterotonics after birth are the only intervention that has been shown to be effective in preventing PPH. Tranexamic acid (TXA), an antifibrinolytic agent, has been investigated as a potentially useful complement to uterotonics for prevention because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention after cesarean (n = 10) and vaginal (n = 2) deliveries show that women who received TXA had significantly less postpartum blood loss without any increase in their rate of severe adverse effects. However, the quality of these trials was poor and they were not designed to test the effect of TXA on the reduction of PPH incidence. Large, adequately powered, multicenter randomized controlled trials are required before the widespread use of TXA to prevent PPH can be recommended.Methods and designA multicenter, double-blind, randomized controlled trial will be performed. It will involve 4000 women in labor for a planned vaginal singleton delivery, at a term ≥ 35 weeks. Treatment (either TXA 1 g or placebo) will be administered intravenously just after birth. Prophylactic oxytocin will be administered to all women. The primary outcome will be the incidence of PPH, defined by blood loss ≥500 mL, measured with a graduated collector bag. This study will have 80 % power to show a 30 % reduction in the incidence of PPH, from 10.0 % to 7.0 %.DiscussionIn addition to prophylactic uterotonic administration, a complementary component of the management of third stage of labor acting on the coagulation process may be useful in preventing PPH. TXA is a promising candidate drug, inexpensive, easy to administer, and simple to add to the routine management of deliveries in hospitals. This large, adequately powered, multicenter, randomized placebo-controlled trial seeks to determine if the risk-benefit ratio favors the routine use of TXA after delivery to prevent PPH.Trial registrationClinicalTrials.gov NCT02302456 (November 17, 2014)

Hypogastric arteries ligation for the management of postpartum hemorrhage: a simple method of reducing uterine bleeding during surgery

“…Our prevalence of PPH (6.4%) is within the range of 3-15% described in literature 1 . The mean maternal age noticed in our study (29 years) is similar to that of 29.3 years reported in Tunisia [10], showing that HAL is usually offered to younger women who need future childbirth.…”

“…Postpartum hemorrhage (PPH) is one of the leading cause of maternal mortality worldwide and the first cause of maternal mortality in Africa [1][2][3]. Causes of PPH include uterine atony, genital tract lacerations, retention of placenta or placental debris and coagulation disorders.…”

Protocol for a pilot, randomised, double-blinded, placebo-controlled trial of prophylactic use of tranexamic acid for preventing postpartum haemorrhage (TAPPH-1)

“…12 Although maternal mortality is relatively rare in developed nations, PPH may be implicated in up to 27% of all cases. 13 Economic burden of PPH Unfortunately, there is a paucity of published data on the true economic impact of maternal haemorrhage. However, as PPH, blood transfusion and hysterectomy are all inter-related and primary drivers of maternal morbidity, even one PPH case is assumed to bequeath a substantial economic burden on society.…”

“…13 Unfortunately, this study has limited external validity since it only includes patients undergoing SVD, and does not capture women undergoing operative deliveries. In addition, there are many exclusion criteria, the investigators use in their study design which would make any results of this trial less generalisable.…”

Massive Postpartum Hemorrhage: Protocol and Red Code

“…This study will provide valuable information on the role of early TXA in reducing progression from mild to severe PPH. There are other open studies to determinate the role of TXA as a complementary treatment of third stage of labor, in addition to prophylactic uterotonic drugs [39].…”