Recruiting EARLY_PHASE1 Cesarean Delivery

New treatment option for Cesarean Delivery

Official title Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery

ClinicalTrials.gov ID: NCT07362992

What this study is testing

What is Tranexamic Acid (Topical)?

Tranexamic Acid (Topical) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cesarean delivery.

Also referred to as Hexakapron.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 1: an early, usually small safety study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 51, women only. Healthy volunteers may be eligible.

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Holon, Central District, Israel
  • Kfar Saba, Israel
  • Petah Tikva, Israel
  • Rehovot, Israel

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years to 51 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Holon, Central District, Israel; Kfar Saba, Israel; Petah Tikva, Israel; Rehovot, Israel. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.