The goal of this clinical trial is to learn whether applying topical tranexamic acid (TXA) directly to the uterine incision during cesarean delivery can reduce surgical bleeding compared to placebo. The study will include pregnant women aged 18-51 undergoing elective cesarean delivery at term (37 weeks or more). The main questions it aims to answer are: * Does topical TXA shorten uterine closure time? * Does topical TXA reduce the need for additional hemostatic sutures? Researchers will compare women receiving topical TXA to those receiving placebo (normal saline) to see if TXA reduces intraoperative bleeding and improves surgical outcomes. Participants will: * Be randomly assigned to receive either topical TXA or placebo during cesarean delivery. * Have standard surgery and postoperative care identical in both groups. * Provide routine clinical data, including hemoglobin levels and recovery outcomes, from their medical records.
Cesarean delivery carries a recognized risk of significant intraoperative bleeding despite standard uterotonic use and established surgical techniques. Tranexamic acid (TXA), an antifibrinolytic medication, reduces surgical blood loss when administered intravenously, but little is known about the effectiveness of topical TXA applied directly to the uterine incision during cesarean delivery. Evidence from other surgical fields suggests that topical TXA may reduce bleeding with minimal systemic absorption. This study is a multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate whether topical TXA decreases intraoperative bleeding during elective cesarean delivery at term. A total of 112 participants will be randomized in a 1:1 ratio to receive either TXA (500 mg diluted in 15 mL saline) or an identical-appearing saline placebo. The study drug is applied by spraying the solution directly onto the uterine incision after placental delivery and before each layer of uterine closure. Randomization will be stratified by site, and allocation will be concealed using sequentially numbered envelopes opened by a scrub nurse. All cesarean procedures will follow a standardized operative technique to minimize variability. Intraoperative and postoperative data will be collected from medical records, including operative characteristics, perioperative hemoglobin values, use of additional hemostatic measures, length of stay, and maternal or neonatal complications. Safety monitoring will focus on thromboembolic events, allergic reactions, and postoperative infections, with periodic review by an independent safety officer. This trial aims to determine whether a localized, low-cost antifibrinolytic intervention can improve hemostasis during cesarean delivery and potentially be incorporated into routine surgical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
112
This intervention involves topical application of tranexamic acid (TXA) directly to the uterine incision during cesarean delivery, rather than the conventional intravenous route. A solution containing 500 mg of TXA (one ampule, 5 mL) diluted in 15 mL of normal saline is sprayed evenly over the uterine incision surface after placental delivery and before suturing. A second application of the same solution is sprayed before the second layer of uterine closure. This localized, site-directed use is designed to reduce intraoperative bleeding with minimal systemic absorption, distinguishing it from previously studied intravenous TXA regimens.
This comparator intervention involves topical application of sterile normal saline to the uterine incision at the same time points as in the TXA arm - after placental delivery and before each layer of uterine closure. The saline is visually indistinguishable from the TXA solution, ensuring blinding of participants and surgical teams. This placebo control enables a direct comparison to determine whether the topical TXA application provides added benefit in reducing intraoperative bleeding.
Edith Wolfson Medical Center
Holon, Central District, Israel
Meir medical center
Kfar Saba, Israel
Rabin medical center
Petah Tikva, Israel
Kaplan medical center
Rehovot, Israel
Uterine closure time (minutes)
Time from placement of the first uterine stitch to completion of the final uterine stitch including any additional hemostatic sutures (In minutes)
Time frame: Intraoperative (during the index cesarean delivery)
Number of additional hemostatic sutures (count)
Total number of extra hemostatic stitches needed for bleeding control beyond the routine two-layer uterine closure
Time frame: Intraoperative (during the index cesarean delivery)
Estimated intraoperative blood loss (mL)
Blood loss estimated by the operating surgeon during the cesarean delivery, recorded at the end of the procedure using standardized estimation protocols.
Time frame: Intraoperative (during the index cesarean delivery)
Change in hemoglobin levels
Difference between preoperative hemoglobin concentration and hemoglobin measured 16-24 hours after surgery, expressed in g/dL.
Time frame: 16-24 hours postoperatively
Need for additional uterotonic agents
Administration of additional uterotonic medications beyond routine prophylactic Oxycontin during surgery and up to 24 postoperative
Time frame: Intra-operative to 24 hours postoperative
Need for blood transfusion
Incidence of red blood cell transfusion due to surgical blood loss or postoperative anemia.
Time frame: within 30 days postoperativly
Duration of hospital admission (days)
Number of days from the cesarean delivery to hospital discharge.
Time frame: Postoperative within 30 days from delivery
Postoperative complications
Occurrence of any postoperative maternal complications, including fever, endometritis, wound infection, thromboembolic events, or reoperation
Time frame: Up to 30 days after surgery
Post-discharge emergency department visits or hospital readmissions
Any maternal emergency department visits or readmissions related to the delivery within one month of cesarean section.
Time frame: Within 30 days postpartum
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