Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

NCT ID: NCT03870256

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-09-01

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.

Conditions

Post Partum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TA plus misoprostol

Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm

Group Type: ACTIVE_COMPARATOR

misoprostol

Intervention Type: DRUG

Patient receive 600mic gm sublingual misoprostol

TA

Intervention Type: DRUG

The patient receives 1gm oral tranexamic acid

Carbetocin

Patient receives 100 mic gm carbetocin IV

Group Type: ACTIVE_COMPARATOR

Carbetocin

Intervention Type: DRUG

Patient receive 100 mic gm carbetocin IV

Interventions

misoprostol

Patient receive 600mic gm sublingual misoprostol

Intervention Type: DRUG

Carbetocin

Patient receive 100 mic gm carbetocin IV

Intervention Type: DRUG

TA

The patient receives 1gm oral tranexamic acid

Intervention Type: DRUG

Other Intervention Names

Active comparator; Active Comparator; Active Comparator

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f allam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

AswanUH

Aswān, , Egypt

Countries

Egypt

Other Identifiers

aswu/200/19

Identifier Type: -

Identifier Source: org_study_id