Nambiath Sujata1, Raj Tobin2, Ranjeet Kaur2, Anjila Aneja3, Mona Khanna2, Vijay M Hanjoora2. 1. Department of Anaesthesia, Max Hospital, Saket, New Delhi, India. Electronic address: drnambiath@yahoo.com. 2. Department of Anaesthesia, Max Hospital, Saket, New Delhi, India. 3. Department of Obstetrics and Gynecology, Fortis Hospitals, New Delhi, India.
Abstract
OBJECTIVE: To assess the effects of tranexamic acid among patients undergoing cesarean delivery who were at high risk of postpartum hemorrhage. METHODS:Between August 1, 2012, and April 30, 2013, a randomized controlled trial was performed at a tertiary care center in India. Women undergoing an elective or emergency cesarean delivery who were at high risk for postpartum hemorrhage were enrolled. They were randomly assigned using sealed, opaque envelopes to receive 10mg/kg tranexamic acid or normal saline 10min before skin incision. Anesthesiologists were not masked to group assignment, but patients and obstetricians were. The primary outcome was need for additional uterotonic drugs within 24h after delivery. Analyses were by intention to treat. RESULTS:Thirty patients were assigned to each group. Additional uterotonic drugs were required in 7 (23%) patients assigned to tranexamic acid and 25 (83%) patients in the control group (P<0.001). CONCLUSION:Intravenous tranexamic acid, administered before skin incision, significantly reduced the requirement for additional uterotonics among women at increased risk for postpartum hemorrhage. Clinical Trials Registry India: CTRI/2015/05/005752.
RCT Entities:
OBJECTIVE: To assess the effects of tranexamic acid among patients undergoing cesarean delivery who were at high risk of postpartum hemorrhage. METHODS: Between August 1, 2012, and April 30, 2013, a randomized controlled trial was performed at a tertiary care center in India. Women undergoing an elective or emergency cesarean delivery who were at high risk for postpartum hemorrhage were enrolled. They were randomly assigned using sealed, opaque envelopes to receive 10mg/kg tranexamic acid or normal saline 10min before skin incision. Anesthesiologists were not masked to group assignment, but patients and obstetricians were. The primary outcome was need for additional uterotonic drugs within 24h after delivery. Analyses were by intention to treat. RESULTS: Thirty patients were assigned to each group. Additional uterotonic drugs were required in 7 (23%) patients assigned to tranexamic acid and 25 (83%) patients in the control group (P<0.001). CONCLUSION: Intravenous tranexamic acid, administered before skin incision, significantly reduced the requirement for additional uterotonics among women at increased risk for postpartum hemorrhage. Clinical Trials Registry India: CTRI/2015/05/005752.
Authors: Nguyen Toan Tran; Sarah Bar-Zeev; Catrin Schulte-Hillen; Willibald Zeck Journal: Int J Environ Res Public Health Date: 2022-06-16 Impact factor: 4.614