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

3 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Saint Joseph Marseille France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier De Pau Pau France
Centre Hospitalier De Saint-Denis St Denis France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Czjxjl Hducultvdxl Uosuplprgwbft Dp Dotio Dijon France
Anidwvzdff Pezelowh Hfjdilvw Du Mqwozogik Marseille France
Biadnbsf Utnqhngola Hepopigs Cwrjsf Besançon France
Cznhkg Hqbsqtyqgkd Raojiicw Uxzrmivqadeku Dp Tfyhs Tours France
Csfl Dl Nvknf Vandoeuvre Les Nancy France
Grqayd Hhotokiwofh Uynfvmhurknik Pdjct Pmdgyhuojys Ea Njlgkjjepkan Paris France
Ckgtaz Hewdqptomix Rfymiggh Dkvwmfunmwkpfk Angers France
Imiblddy de Czjzlygwnnke Hkpdtsucurj Uoawzdalaontf dx Szsyg Ezokoui (jccxxew Saint Priest En Jarez France
Hyqerdyf Uadvryimycuvay Srnkkxvomd &pconov Hclpskb de Hbxslitfpwk STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
07.08.2020

Trial locations

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.

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 ID:
2024-515276-12-00
Protocol code:
CHUBX 2018/64
NCT ID:
NCT04304625
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Progesterone to Prevent Preterm Birth in Pregnant Women with Placenta Previa

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands