NCT03870256

Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

The Effect of Oral Tranexamic Acid Plus, Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery

Detailed description

Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.

Conditions

• Post Partum Hemorrhage

Interventions

Type	Name	Description
DRUG	misoprostol	Patient receive 600mic gm sublingual misoprostol
DRUG	Carbetocin	Patient receive 100 mic gm carbetocin IV
DRUG	TA	The patient receives 1gm oral tranexamic acid

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-08-01
• Completion: 2021-09-01
• First posted: 2019-03-12
• Last updated: 2021-09-29

Locations

1 site across 1 country: Egypt