Ahmed Abu-Zaid1, Saeed Baradwan2, Majed Saeed Alshahrani3, Hanadi Bakhsh4, Ehab Badghish5, Khalid Khadawardi6, May A AlRasheed7, Abdulrhman Turkistani8, Nora F AlNaim9, Latifa F AlNaim9, Meshael Fodaneel9, Fatimah Shakir AbuAlsaud9, Mohammed Ziad Jamjoom9, Maha Tulbah9, Maisoon Almugbel9, Osama Alomar9, Haifa Al-Jundi10, Hassan Saleh Allam11, Safa Alabdrabalamir12, Hany Salem13, Ismail A Al-Badawi13. 1. College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, USA; Department of Obstetrics and Gynecology, Alfaisal University, Riyadh, Saudi Arabia. Electronic address: aabuzaid@live.com. 2. Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia. 3. Department of Obstetrics and Gynecology, Faculty of Medicine, Najran University, Najran, Saudi Arabia. 4. Clinical Sciences Department, College of Medicine, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia. 5. Department of Obstetrics and Gynecology, Maternity and Children Hospital, Makkah, Saudi Arabia. 6. Department of Obstetrics and Gynecology, Faculty of Medicine, Umm Al-Qura University, Makkah, Saudi Arabia. 7. Department of Obstetrics and Gynecology, King Saud Hospital, Qassim-Unayzah, Saudi Arabia. 8. Department of Obstetrics and Gynecology, King Fahad Medical City, Riyadh, Saudi Arabia. 9. Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. 10. Department of Obstetrics and Gynecology, Dr. Sulaiman Al-Habib Hospital, Riyadh, Saudi Arabia. 11. Department of Obstetrics and Gynecology, Prince Sultan Military Medical City, Riyadh, Saudi Arabia; Department of Obstetrics and Gynecology, Faculty of Medicine in Rabigh, King Abdulaziz University, Rabigh, Saudi Arabia. 12. Riyadh Second Health Cluster, Riyadh, Saudi Arabia. 13. Department of Obstetrics and Gynecology, Alfaisal University, Riyadh, Saudi Arabia; Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Abstract
OBJECTIVE: To conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that inspected the efficacy and safety of prophylactic TXA compared with control (placebo/no treatment) among women undergoing vaginal delivery on reducing postpartum blood loss and related morbidities. METHODS: Six databases were screened from inception until 06-December-2021. The pooled data were summarized as mean difference or risk ratio, respectively, with 95% confidence interval in a fixed- or random-effects model. RESULTS: Sixteen studies comprising 17 RCT treatment arms were included. There were 7122 patients; 3611 and 3511 patients were allocated to prophylactic TXA and control groups, respectively. Overall, the included RCTs had a low risk of bias. Prophylactic TXA correlated with a significant decrease in mean postpartum blood loss and mean change in hemoglobin/hematocrit. Moreover, prophylactic TXA was linked to decreased incidence rates of postpartum hemorrhage, need for blood transfusion, and need for additional uterotonic agents. Nevertheless, prophylactic TXA culminated in significantly higher incidence rates of nausea, vomiting, and diarrhea, all of which were well-tolerated. There was no increased risk of thromboembolic events. Leave-one-out sensitivity analysis confirmed the robustness of efficacy endpoints. There was no publication bias for the endpoint of mean postpartum blood loss. CONCLUSION: Among patients undergoing vaginal delivery, prophylactic TXA during active management of third stage of labor (AMTSL) appeared largely safe and correlated with a significant decrease in postpartum blood loss and related morbidities compared with control intervention. Prophylactic TXA should be integrated as a "formal" component of AMTSL among women undergoing vaginal delivery.
OBJECTIVE: To conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that inspected the efficacy and safety of prophylactic TXA compared with control (placebo/no treatment) among women undergoing vaginal delivery on reducing postpartum blood loss and related morbidities. METHODS: Six databases were screened from inception until 06-December-2021. The pooled data were summarized as mean difference or risk ratio, respectively, with 95% confidence interval in a fixed- or random-effects model. RESULTS: Sixteen studies comprising 17 RCT treatment arms were included. There were 7122 patients; 3611 and 3511 patients were allocated to prophylactic TXA and control groups, respectively. Overall, the included RCTs had a low risk of bias. Prophylactic TXA correlated with a significant decrease in mean postpartum blood loss and mean change in hemoglobin/hematocrit. Moreover, prophylactic TXA was linked to decreased incidence rates of postpartum hemorrhage, need for blood transfusion, and need for additional uterotonic agents. Nevertheless, prophylactic TXA culminated in significantly higher incidence rates of nausea, vomiting, and diarrhea, all of which were well-tolerated. There was no increased risk of thromboembolic events. Leave-one-out sensitivity analysis confirmed the robustness of efficacy endpoints. There was no publication bias for the endpoint of mean postpartum blood loss. CONCLUSION: Among patients undergoing vaginal delivery, prophylactic TXA during active management of third stage of labor (AMTSL) appeared largely safe and correlated with a significant decrease in postpartum blood loss and related morbidities compared with control intervention. Prophylactic TXA should be integrated as a "formal" component of AMTSL among women undergoing vaginal delivery.