Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

Aswan University Hospital135 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

135

Conditions

Post Partum Hemorrhage

Interventions

misoprostolDRUG

Patient receive 600mic gm sublingual misoprostol

CarbetocinDRUG

Patient receive 100 mic gm carbetocin IV

TADRUG

The patient receives 1gm oral tranexamic acid

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

AswanUH

Aswān, Egypt

Outcomes

Primary Outcomes

the amount of blood loss

the amount of blood loss by gm calculated by gravimetric methods

Time frame: 6 hours post delivery

Secondary Outcomes

number of patients loss more than 1000 ml blood

calculate number of patients loss more than 1000 ml blood

Time frame: 24 hours post delivery

need of uterotonics

number of patients need of uterotonics

Time frame: 24 hours post delivery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.