Cesarean DeliveryEarly Phase 1NCT07362992
Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery
A Early Phase 1 study testing Tranexamic Acid (Topical) in people with Cesarean Delivery and Postpartum Hemorrhage (PPH), run by Wolfson Medical Center at 4 sites in Israel.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery, Postpartum Hemorrhage (PPH), Intraoperative Blood Loss
- What is being tested?
- Tranexamic Acid (Topical)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 4 sitesIsrael
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Planned or intraoperative conversion to general anesthesia
- Known uterine malformations
- Known bleeding tendency or thromboembolic disease
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel4 sites, 4 recruiting
- Recruiting
Edith Wolfson Medical Center
Holon, Central District, 5834468
0546738294
- Not yet recruiting
Meir medical center
Kfar Saba
- Not yet recruiting
Rabin medical center
Petah Tikva
- Not yet recruiting
Kaplan medical center
Rehovot
About this study
Official title: Does Topical Use of Tranexamic Acid During a Cesarean Delivery Reduce Intra-surgical Bleeding? A Randomized ,Multi-center Trial
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Tranexamic Acid (Topical), Normal Saline (Placebo)
- Keywords
- Tranexamic Acid, Topical Tranexamic Acid, Hexakapron, Cesarean Delivery, Cesarean Section, Elective Cesarean, Postpartum Hemorrhage, Intraoperative Bleeding, Blood Loss Prevention, Uterine Closure, Randomized Controlled Trial, Maternal Outcomes
- Medical subject headings
- Postpartum Hemorrhage, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (Topical)Drug
Also called Hexakapron
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.
Normal Saline (Placebo)Other
Also called NaCl 0.9%
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tranexamic Acid (Topical) |
| 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. Receives: Other: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Intraoperative (during the index cesarean delivery)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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
Measured: Intra-operative to 24 hours postoperative
Need for blood transfusion
Incidence of red blood cell transfusion due to surgical blood loss or postoperative anemia.
Measured: within 30 days postoperativly
Duration of hospital admission (days)
Number of days from the cesarean delivery to hospital discharge.
Measured: Postoperative within 30 days from delivery
Postoperative complications
Occurrence of any postoperative maternal complications, including fever, endometritis, wound infection, thromboembolic events, or reoperation
Measured: 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.
Measured: Within 30 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jul 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Collaborators
- Rabin Medical Center, Meir Medical Center, Kaplan Medical Center
- Responsible party
- Principal investigator, Liat Mor, Wolfson Medical Center
- Investigators
- Amichai Rottenstreich, Principal investigator, Edith Wolfson Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362992
- Sponsor's protocol ID
- 0191-25-WOMC
- Status last verified
- Jul 2026
- First submitted
- 15 Nov 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No