Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Tranexamic Acid to Prevent Blood Loss in Women with Placenta Previa Undergoing Cesarean Delivery

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Postpartum Hemorrhage, which is excessive bleeding following childbirth. The study is specifically looking at women who have a condition called placenta previa, where the placenta is positioned low in the uterus and can cause complications during delivery. The trial is testing the effectiveness of a medication called Tranexamic Acid, also known by the code name LB1148, in reducing blood loss after a cesarean delivery. Tranexamic Acid is a chemical substance that helps prevent excessive bleeding by aiding blood clotting. The study will compare the effects of this medication to a placebo, which is a substance with no active therapeutic effect.

The purpose of the study is to determine if administering a low dose of Tranexamic Acid shortly after the baby is delivered can reduce the need for a blood transfusion before the mother is discharged from the hospital. Participants in the study will receive either Tranexamic Acid or a placebo through an injection shortly after their cesarean delivery. The study will monitor the amount of blood loss and whether a blood transfusion is needed, as well as any side effects that may occur. The trial will also look at other factors such as the mother's recovery and overall health after delivery.

Throughout the study, participants will be observed for any potential side effects of Tranexamic Acid, such as nausea or dizziness, and for any serious complications like blood clots. The study will also assess the mother's satisfaction with her delivery experience and her psychological well-being after childbirth. The trial aims to provide valuable information on whether Tranexamic Acid can be a safe and effective way to manage blood loss in women with placenta previa undergoing cesarean delivery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is confirmed based on criteria such as age, diagnosis of placenta previa, and planned cesarean delivery.

    Informed consent is signed to participate in the study.

  2. Step 2

    Delivery and medication administration

    During the cesarean delivery, a low dose of tranexamic acid (1 gram) is administered intravenously within 3 minutes after the child is delivered.

    This is done in addition to the usual medication given to help the uterus contract.

  3. Step 3

    Post-delivery monitoring

    Blood loss is measured using specific methods to ensure accurate assessment.

    The need for a blood transfusion is evaluated from the time of delivery until discharge from the hospital.

  4. Step 4

    Postpartum care

    Additional treatments, such as iron sucrose, may be given if necessary.

    Monitoring for any side effects or complications, such as nausea or dizziness, occurs during the hospital stay.

  5. Step 5

    Follow-up assessments

    A questionnaire is completed on the second day after delivery to assess satisfaction and psychological status.

    A follow-up questionnaire is sent by mail at 8 weeks postpartum to further assess psychological status.

  6. Step 6

    Long-term monitoring

    Monitoring for any serious complications, such as blood clots or other unexpected reactions, continues up to 12 weeks after delivery.

    A telephone interview is conducted at 12 weeks postpartum to check for any long-term effects.

Who can join the trial?

6 criteria

  • Must be **18 years or older**.
  • Have a condition called **placenta previa**, which means the placenta is located too close to the opening of the cervix, as seen in the most recent ultrasound before delivery.
  • Undergoing a **cesarean delivery**, which is a surgical procedure to deliver the baby.
  • Pregnancy must be at least **32 weeks along** at the time of delivery.
  • Must be part of or have access to a **health security system**.
  • Must have **signed informed consent**, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

5 criteria

  • Women who are not experiencing postpartum hemorrhage, which is heavy bleeding after giving birth, cannot participate.
  • Women who do not have placenta previa, a condition where the placenta covers the opening of the cervix, are excluded.
  • Women who are not undergoing a cesarean delivery, which is a surgical procedure to deliver a baby, cannot join the study.
  • Men are not eligible to participate in this study.
  • Individuals who are not considered part of a vulnerable population, which includes groups that may need special protection, are excluded.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Tranexamic Acid (TXA)

    is used in this trial to help prevent blood loss in women undergoing a cesarean delivery with placenta previa. It is given shortly after the child is delivered to see if it can reduce the need for a blood transfusion during the hospital stay after delivery.

  • Uterotonic

    medications are also used in this trial. These are drugs that help the uterus contract after childbirth, which can help reduce bleeding. They are given as a standard part of care during a cesarean delivery.

What is already known about the treatment

Tranexamic Acid – Tranexamic Acid is administered intravenously, typically as a low dose of 1 gram, given within 3 minutes after childbirth. It is currently being studied in clinical trials for its effectiveness in reducing blood loss in women undergoing cesarean delivery with placenta previa. The main therapeutic indication is to prevent postpartum hemorrhage, a condition characterized by excessive bleeding after childbirth. At the molecular level, Tranexamic Acid works by inhibiting the breakdown of fibrin, a protein essential for blood clotting, thereby helping to stabilize blood clots and reduce bleeding. It is classified as an antifibrinolytic agent.

Investigated diseases

Postpartum Hemorrhage – This condition occurs when a woman experiences significant bleeding after giving birth. It is most common within the first 24 hours after delivery but can occur up to 12 weeks postpartum. The bleeding is often due to the uterus not contracting properly after the placenta is delivered, which can lead to excessive blood loss. Other causes may include retained placental tissue, tears in the cervix or vaginal tissues, and blood clotting disorders. The progression of postpartum hemorrhage can vary, with some women experiencing mild symptoms while others may have severe bleeding that requires medical intervention. Monitoring and managing blood loss are crucial to prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515276-12-00Protocol codeCHUBX 2018/64Estimated enrolment1 380 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.