麻豆传媒

DALLAS -- Tranexamic acid (TXA) was linked with a lower risk of postpartum hemorrhage among women who were given the drug immediately following delivery, according to a randomized trial presented here.

Among women with a vaginal delivery who received prophylactic oxytocin, a smaller portion experienced postpartum hemorrhage who were given tranexamic acid within 2 minutes after delivery compared with a control group who received placebo (8.1% versus 9.8%, respectively), and these results trended towards significance, reported Loïc Sentilhes, MD, of Bordeaux University Hospital in France.

At a at the , he and his co-authors emphasized that while tranexamic acid has been used in elective surgeries and trauma patients, and for menstrual blood loss, there has been scant research on its application prior to delivery.

Asked for his opinion, Robert Silver, MD, of the University of Utah in Salt Lake City, who was not involved with the research, said that this treatment has not become the absolute standard of care because there have not been a lot of studies on the drug in pregnant women.

"Many centers are now using this in patients who are bleeding, and it's become generally accepted, but not absolutely standard, to treat postpartum hemorrhage," he told 麻豆传媒.

Sentilhes and his colleagues conducted a multicenter study in France, where 4,079 women in labor for a term vaginal delivery (defined as ≥35 weeks) with a singleton live fetus were randomized to receive either 1 g of TXA or placebo along with prophylactic oxytocin within 2 minutes after delivery. Overall, 2,039 women were allocated to placebo and 2,040 were allocated to receive TXA.

An intention-to-treat analysis of 3,891 patients who underwent vaginal delivery found there was a lower risk of postpartum hemorrhage, which was defined as blood loss ≥500 mL, among women receiving TXA (RR 0.83, 95% CI 0.68-1.01, P=0.07).

However, the TXA group was associated with significant differences in rates of other outcomes related to postpartum hemorrhage, including:

• Postpartum hemorrhage, defined as blood loss of >500 mL (RR 0.75, 95% CI 0.61-0.94, P=0.01)
• Clinically significant postpartum hemorrhage, according to caregivers (RR 0.74, 95% CI 0.61-0.91, P=0.004)
• Additional uterotonics (RR 0.75, 95% CI 0.61-0.92, P=0.006)

Also asked for her perspective, Jeanne Sheffield, MD, director of the Division of Maternal-Fetal Medicine at Johns Hopkins University in Baltimore and also not involved with the research, said that the study provided "strong evidence" that TXA is "an effective prophylactic agent," and she saw global applications for the findings: "This will have a global impact, considering that obstetric hemorrhage remains one of the leading causes of maternal mortality worldwide."

In terms of side effects, nausea and/or vomiting was found to be significantly more common in the TXA group versus placebo (7.0% versus 3.2%, RR 2.16, 95% CI 1.61-2.89, P<0.0001). There was no increased risk of severe adverse events, including thrombotic complications, 3 months after delivery, the researchers said.

Sentilhes also noted that pre-specified group analyses found that TXA reduced the primary outcome among women with instrumental delivery, but not spontaneous delivery, and in women with episiotomy, but not in those without episiotomy.

Silver added that that while this issue is certainly worth studying in further research, he was not sure that clinicians would adopt this as a preventive measure based on this study: "I don't know if it's convincing enough, and whether it's worth the cost and potential side effects remain uncertain. I'm not sure it's going to change practice."