Is Tranexamic Acid Safe During Pregnancy?

Tranexamic acid (TXA) is a medication utilized to prevent or reduce severe blood loss, acting as a powerful tool in hemorrhagic emergencies. Using any medication during pregnancy requires balancing the necessity of treating the mother’s condition against potential effects on the developing fetus. Since excessive bleeding poses an immediate threat, TXA administration is generally reserved for situations where the potential maternal benefit outweighs the risks to both mother and child.

How Tranexamic Acid Works to Control Bleeding

Tranexamic acid functions as an antifibrinolytic agent, preventing the premature dissolution of blood clots the body has already formed. TXA is a synthetic derivative of the amino acid lysine. It exerts its effect by competitively binding to specific receptor sites on the protein plasminogen.

By occupying the lysine-binding sites on plasminogen, TXA blocks its conversion into the active form, plasmin. Plasmin is the primary enzyme responsible for breaking down the fibrin meshwork that stabilizes a blood clot. This inhibition of plasmin formation prevents the enzymatic breakdown of fibrin, effectively stabilizing the clot and maintaining hemostasis. TXA protects the existing clot from being destroyed, sustaining the body’s natural bleeding control mechanisms.

Medical Scenarios Requiring TXA During Pregnancy

TXA is typically reserved for urgent, life-threatening scenarios where the pregnant person is at risk of significant blood loss. The most prominent indication is the treatment of severe postpartum hemorrhage (PPH), a leading cause of maternal mortality worldwide. TXA is administered for excessive bleeding after childbirth, often in conjunction with other treatments like uterine massage and uterotonic drugs.

The medication may also be used in cases of severe antepartum hemorrhage (bleeding that occurs before delivery). This includes managing significant bleeding episodes associated with conditions like placenta previa, where the placenta partially or totally covers the cervix. Although clinical guidance is less definitive for prophylactic use, some studies have explored its role in reducing bleeding in women with threatened miscarriage. The decision to use TXA reflects the severity of the bleeding.

Assessing Risks to Mother and Fetus

Assessing TXA safety involves evaluating potential risks to both the mother and the fetus. The primary maternal concern is the risk of blood clot formation, as pregnancy is already a hypercoagulable state, raising theoretical concerns about TXA increasing the risk of thromboembolic events. However, large-scale clinical trials, such as the WOMAN trial focusing on postpartum hemorrhage, demonstrated that TXA administration does not significantly increase the risk of maternal thromboembolic complications, such as deep vein thrombosis or pulmonary embolism, compared to a placebo.

Despite this reassuring data, a small number of maternal thrombosis cases have been reported in exposed pregnancies, but controlled studies have not established a clear causal link to TXA. The overall safety profile suggests that the benefit of preventing fatal hemorrhage outweighs the low risk of a clot. Common, non-serious maternal side effects can include gastrointestinal disturbances like nausea, vomiting, or diarrhea, which are generally transient.

Regarding the fetus, TXA is known to cross the placental barrier, with concentrations in the umbilical cord blood potentially reaching levels similar to those in the mother’s blood. Data on fetal safety is limited, consisting mainly of case reports and small studies. There are no large, well-controlled human studies on exposure during early pregnancy. Animal studies generally suggest a low risk of harm to the fetus.

Existing human data has not established an association between TXA exposure and an increased frequency of major congenital malformations. Some cases of miscarriage, preterm delivery, and low infant birth weight have been sporadically described, though it is difficult to separate these outcomes from the severe underlying maternal condition that necessitated the drug’s use. The lack of extensive early-pregnancy data means TXA is used cautiously, but its administration is not typically considered grounds for terminating a pregnancy.

Current Clinical Recommendations and Monitoring

Major international health organizations, including the World Health Organization (WHO), strongly recommend the early use of intravenous TXA for treating clinically diagnosed postpartum hemorrhage. This recommendation is based on strong evidence that TXA significantly reduces death due to bleeding, especially when administered within three hours of birth. The standard dosing regimen for PPH is typically a fixed dose of one gram administered intravenously over 10 minutes, with the option for a second one-gram dose if bleeding persists or restarts within 24 hours.

The prevailing clinical consensus is that TXA should be considered in obstetric hemorrhage when initial treatments have failed, underscoring its role as a potentially life-saving intervention. Careful monitoring for signs of thromboembolic events is standard practice, particularly in patients with a pre-existing history of clotting disorders. This informed approach ensures that the drug is reserved for patients where the therapeutic benefit is highest, while minimizing potential side effects.