Does Topical Use of Tranexamic Acid During a Cesarean Delivery Reduce Intra-surgical Bleeding? A Randomized ,Multi-center Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 4
- 主要终点
- Uterine closure time (minutes)
研究概览
简要总结
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.
详细描述
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, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 to 51 years
- •Singleton pregnancy
- •Elective cesarean delivery scheduled at ≥37+0 weeks of gestation
- •First or second cesarean delivery only
- •Low transverse uterine incision planned
- •Double-layer uterine closure using 1-0 Vicryl sutures
- •Ability to provide written informed consent
排除标准
- •Known allergy or hypersensitivity to tranexamic acid (TXA)
- •History of bleeding or coagulation disorders
- •Previous postpartum hemorrhage
- •Placenta previa or placenta accreta spectrum
- •Presence of uterine myomas
- •Current use of anticoagulant or antiplatelet medications
- •Planned or intraoperative conversion to general anesthesia
- •Known uterine malformations
- •Known bleeding tendency or thromboembolic disease
研究组 & 干预措施
Topical Tranexamic Acid (TXA) Group
Participants in this group will receive topical tranexamic acid (TXA) applied directly to the uterine incision during cesarean delivery. After the baby and placenta are delivered, the surgeon will spray a solution containing 500 mg of TXA (one ampule, 5 mL) diluted in 15 mL of normal saline onto the uterine incision before suturing begins. After the first layer of sutures is placed, a second syringe of the same TXA solution will be sprayed before the second layer of closure. All other aspects of the surgical technique and postoperative care will follow standard practice.
干预措施: Tranexamic Acid (Topical) (Drug)
Placebo (Normal Saline) Group
Participants in this group will receive a placebo solution of normal saline applied in the same manner and at the same time points as in the TXA group. After the baby and placenta are delivered, the surgeon will spray 20 mL of sterile saline onto the uterine incision before closure, and again before completing the second layer of sutures. All other surgical and postoperative procedures will be identical to those in the TXA group.
干预措施: Normal Saline (Placebo) (Other)
结局指标
主要结局
Uterine closure time (minutes)
时间窗: Intraoperative (during the index cesarean delivery)
Time from placement of the first uterine stitch to completion of the final uterine stitch including any additional hemostatic sutures (In minutes)
Number of additional hemostatic sutures (count)
时间窗: Intraoperative (during the index cesarean delivery)
Total number of extra hemostatic stitches needed for bleeding control beyond the routine two-layer uterine closure
次要结局
- Duration of hospital admission (days)(Postoperative within 30 days from delivery)
- Estimated intraoperative blood loss (mL)(Intraoperative (during the index cesarean delivery))
- Change in hemoglobin levels(16-24 hours postoperatively)
- Need for additional uterotonic agents(Intra-operative to 24 hours postoperative)
- Need for blood transfusion(within 30 days postoperativly)
- Postoperative complications(Up to 30 days after surgery)
- Post-discharge emergency department visits or hospital readmissions(Within 30 days postpartum)
研究者
Liat Mor
principal investigator
Wolfson Medical Center