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 PURPOSEPregnant 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 EXPECTParticipation 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 Magee Womens-Hospital to find out if you need any other treatment or have had any problems since going home.
IRB:STUDY19020133 - Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean Delivery: A Randomized Controlled Trial (TXA)
MEET THE RESEARCHER
Hyagriv Simhan, MD, MSCR, is professor at the University of Pittsburgh School of Medicine, and chief of the division of maternal-fetal medicine and medical director of obstetrical services at Magee-Womens Hospital of UPMC. His main area of research has been on preterm birth. Because of his efforts to improve patient safety and quality of care, Dr. Simhan has been awarded the Fine Award from the Pittsburgh Regional Health Initiative, and the Achievement Award for Health Care Quality Improvement/Patient Safety from the Hospital Association of Pennsylvania.