Clinical Trials for Postpartum Haemorrhage
This article provides information about ongoing clinical trials investigating ways to prevent and manage postpartum haemorrhage, a serious complication involving excessive bleeding after childbirth. Currently, there is 1 clinical trial examining the use of Tranexamic Acid in women with placenta previa undergoing cesarean delivery.
Clinical trial locations
Study on Tranexamic Acid to Prevent Blood Loss in Women with Placenta Previa Undergoing Cesarean Delivery
This clinical trial is investigating whether Tranexamic Acid can help reduce blood loss in women who have placenta previa and are undergoing cesarean delivery. Placenta previa is a condition where the placenta is positioned low in the uterus, covering or near the cervix, which can cause significant bleeding complications during delivery.
Who can participate:
Women who wish to join this study must meet several criteria. They must be at least 18 years old and have a confirmed diagnosis of placenta previa based on their most recent ultrasound before delivery. The pregnancy must be at least 32 weeks along, and the delivery must be planned as a cesarean section. All participants must have access to a health security system and must provide signed informed consent after understanding all aspects of the study.
Who cannot participate:
This trial excludes women who do not have placenta previa or who are not undergoing cesarean delivery. Women who are not experiencing complications related to placenta previa are also excluded. The study is specifically designed for pregnant women, so men and non-pregnant individuals cannot participate.
Focus and goal of the trial:
The main goal of this study is to determine whether giving a low dose of Tranexamic Acid immediately after the baby is delivered can reduce the need for blood transfusion before the mother leaves the hospital. Tranexamic Acid is a medication that helps blood clot more effectively, potentially reducing excessive bleeding. During the cesarean delivery, participants will receive either Tranexamic Acid or a placebo through an intravenous injection within 3 minutes of the baby’s birth. This is given in addition to the standard medications used to help the uterus contract after delivery.
Throughout the study, doctors will carefully measure blood loss using specific methods and monitor whether a blood transfusion becomes necessary. Participants will be observed for any side effects, such as nausea, dizziness, or more serious complications like blood clots. The study also includes follow-up assessments to evaluate the mother’s recovery, satisfaction with the delivery experience, and psychological well-being. A questionnaire is completed on the second day after delivery, and another is sent by mail at 8 weeks postpartum. A telephone interview is conducted at 12 weeks to check for any long-term effects.
Investigational drug:
The medication being tested in this trial is Tranexamic Acid, which is administered as a 1-gram dose through an intravenous injection. This drug works by preventing the breakdown of fibrin, a protein that is essential for forming stable blood clots. By helping blood clots remain stable, Tranexamic Acid may reduce the amount of bleeding that occurs after delivery. In addition to Tranexamic Acid, participants also receive standard uterotonic medications, which are drugs that help the uterus contract properly after childbirth to reduce bleeding.
Summary
Currently, there is one clinical trial addressing postpartum haemorrhage, specifically focusing on women with placenta previa undergoing cesarean delivery. This trial is being conducted in France and is testing the effectiveness of Tranexamic Acid in reducing blood loss and the need for blood transfusions. The study highlights the importance of finding safe and effective methods to manage bleeding complications during childbirth, particularly in high-risk situations like placenta previa. Women who meet the eligibility criteria and are interested in participating should discuss this opportunity with their healthcare provider to determine if the trial is suitable for them.