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| Name | Class |
|---|---|
| Rabin Medical Center | OTHER |
| Meir Medical Center | OTHER |
| Kaplan Medical Center | OTHER |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Tranexamic Acid (TXA) Group | Experimental | 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. |
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| Placebo (Normal Saline) Group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid (Topical) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | Intraoperative (during the index cesarean delivery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative (during the index cesarean delivery) |
| Change in hemoglobin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liat Mor | Contact | +972546738294 | liatmor1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amichai Rottenstreich | Edith Wolfson Medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Wolfson Medical Center | Recruiting | Holon | Central District | 5834468 | Israel |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Normal Saline (Placebo) | Other | 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. This placebo control enables a direct comparison to determine whether the topical TXA application provides added benefit in reducing intraoperative bleeding. |
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Difference between preoperative hemoglobin concentration and hemoglobin measured 16-24 hours after surgery, expressed in g/dL. |
| 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 | Intra-operative to 24 hours postoperative |
| Need for blood transfusion | Incidence of red blood cell transfusion due to surgical blood loss or postoperative anemia. | within 30 days postoperativly |
| Duration of hospital admission (days) | Number of days from the cesarean delivery to hospital discharge. | Postoperative within 30 days from delivery |
| Postoperative complications | Occurrence of any postoperative maternal complications, including fever, endometritis, wound infection, thromboembolic events, or reoperation | 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. | Within 30 days postpartum |
| Meir medical center | Not yet recruiting | Kfar Saba | Israel |
| Rabin medical center | Not yet recruiting | Petah Tikva | Israel |
| Kaplan medical center | Not yet recruiting | Rehovot | Israel |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |