TXA Research Study for Pregnant Women

STUDY BASICS

Are you pregnant with one baby or with twins and plan to have a cesarean delivery (“C-section”) at UPMC Magee-Womens Hospital? If so, you may be eligible to participate in a research study to help find out if giving a drug called tranexamic acid (TXA) immediately after delivery can prevent severe bleeding following a cesarean section. Compensation provided.

STUDY PURPOSE

Pregnant women who deliver by cesarean section (also called a C-section) are at an increased risk of severe bleeding following the birth of a baby. Women who experience severe bleeding after a birth may be treated with blood transfusions, medications, or additional surgery. In some cases, this type of bleeding after delivery can be life-threatening. The purpose of this study is to find out if giving a drug called tranexamic acid (TXA) immediately after delivery can prevent severe bleeding following a cesarean section. Tranexamic acid, which works by making the blot clot more quickly, is routinely used to lessen the chance of bleeding after major operations such as heart surgery but is not approved by the FDA for women undergoing cesarean section.

COULD THIS STUDY BE RIGHT FOR YOU?

• Females aged 18-55
• Pregnant with one baby or with twins
• Plan to deliver by cesarean section (C-section) at UPMC Magee-Womens Hospital

WHAT PARTICIPANTS CAN EXPECT

Participation in this study begins at the time of your cesarean section. It is important to know that participants will be randomly assigned (like the flip of a coin) to receive either tranexamic acid diluted in saline solution, or to receive saline solution alone. The saline solution alone is a placebo and has no medical value. Both study medications are given through an intravenous (IV) tube into a vein in your arm. The tranexamic acid or saline solution will be given immediately after your baby or babies are born using the IV tube that you will already have in place as part of routine care. The dose will start when the umbilical cord is clamped and your blood supply is separated from the blood supply of your baby. It will take 10 minutes to give you the entire dose. A member of the study team will call you about 1 week after delivery to see if you have had any problems since going home. About 6 weeks after your delivery, a member of the study team will call you again or meet with you at a routine visit at UPMC Magee-Womens Hospital to find out if you need any other treatment or have had any problems since going home.