Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

Not Applicable

Completed

• Conditions: Post Partum Hemorrhage
• Interventions: Drug: Carbetocin; Drug: misoprostol; Drug: TA

• Registration Number: NCT03870256
• Lead Sponsor: Aswan University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-12
• Study Start: 2019-04-01
• Primary Completion: 2021-08-01
• Status Verified: 2021-09
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

• All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.

Exclusion Criteria

• were gestational age<37 weeks,
• genital tract trauma,
• coagulation defect,
• women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
• known hypersensitivity to carbetocin or oxytocin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TA plus misoprostol	TA	Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm
Carbetocin	Carbetocin	Patient receives 100 mic gm carbetocin IV
TA plus misoprostol	misoprostol	Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm

Primary Outcome Measures

Name	Time	Method
the amount of blood loss	6 hours post delivery	the amount of blood loss by gm calculated by gravimetric methods

Secondary Outcome Measures

Name	Time	Method
number of patients loss more than 1000 ml blood	24 hours post delivery	calculate number of patients loss more than 1000 ml blood
need of uterotonics	24 hours post delivery	number of patients need of uterotonics

Trial Locations

Locations (1)

AswanUH; 🇪🇬 Aswan, Egypt