Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-51
SponsorWolfson Medical Center
About this 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:
* 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 18 to 51 years
Singleton pregnancy
Elective cesarean delivery scheduled at ≥37+0 weeks of gestation
First or second cesarean delivery only
Disqualifiers
Known allergy or hypersensitivity to tranexamic acid (TXA)
History of bleeding or coagulation disorders
Previous postpartum hemorrhage
Placenta previa or placenta accreta spectrum
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic Acid (Topical)
DrugThis 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 interventionThis 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.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: Topical Tranexamic Acid (TXA) GroupExperimental treatment 1 intervention
Group B: Placebo (Normal Saline) GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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 postoperatively3
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 postoperative4
Need for blood transfusion
Incidence of red blood cell transfusion due to surgical blood loss or postoperative anemia.
Time frame
within 30 days postoperativlySponsors and contacts
Click on the lead sponsor to view all of their trials.
Wolfson Medical Center
Lead sponsor
Rabin Medical Center
Collaborator
Meir Medical Center
Collaborator
Kaplan Medical Center
Collaborator
Source ClinicalTrials.gov