Randomized Controlled Trial of Tranexamic Acid Among Parturients at Increased Risk for Postpartum Hemorrhage Undergoing Cesarean Delivery

Int J Gynaecol Obstet. 2016 Jun;133(3):312-5. doi: 10.1016/j.ijgo.2015.09.032. Epub 2016 Feb 16.

Abstract

Objective: To assess the effects of tranexamic acid among patients undergoing cesarean delivery who were at high risk of postpartum hemorrhage.

Methods: Between August 1, 2012, and April 30, 2013, a randomized controlled trial was performed at a tertiary care center in India. Women undergoing an elective or emergency cesarean delivery who were at high risk for postpartum hemorrhage were enrolled. They were randomly assigned using sealed, opaque envelopes to receive 10mg/kg tranexamic acid or normal saline 10min before skin incision. Anesthesiologists were not masked to group assignment, but patients and obstetricians were. The primary outcome was need for additional uterotonic drugs within 24h after delivery. Analyses were by intention to treat.

Results: Thirty patients were assigned to each group. Additional uterotonic drugs were required in 7 (23%) patients assigned to tranexamic acid and 25 (83%) patients in the control group (P<0.001).

Conclusion: Intravenous tranexamic acid, administered before skin incision, significantly reduced the requirement for additional uterotonics among women at increased risk for postpartum hemorrhage. Clinical Trials Registry India: CTRI/2015/05/005752.

Keywords: Cesarean delivery; High-risk pregnancy; Postpartum hemorrhage; Tranexamic acid.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Intravenous
  • Adult
  • Antifibrinolytic Agents / administration & dosage*
  • Blood Loss, Surgical / prevention & control*
  • Cesarean Section / adverse effects*
  • Female
  • Humans
  • India
  • Postpartum Hemorrhage / prevention & control*
  • Pregnancy
  • Risk Factors
  • Tranexamic Acid / administration & dosage*
  • Treatment Outcome

Substances

  • Antifibrinolytic Agents
  • Tranexamic Acid