Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Partum Hemorrhage

Intervention / Treatment
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* Drug: misoprostol
* Drug: Carbetocin
* Drug: TA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study was a prospective double-blind randomized study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TA plus misoprostol<br>Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm | Drug: misoprostol<br>* Patient receive 600mic gm sublingual misoprostol<br>* Other names: Active comparator;Drug: TA<br>* The patient receives 1gm oral tranexamic acid<br>* Other names: Active Comparator;|
| Active Comparator: Carbetocin<br>Patient receives 100 mic gm carbetocin IV | Drug: Carbetocin<br>* Patient receive 100 mic gm carbetocin IV<br>* Other names: Active Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of blood loss | the amount of blood loss by gm calculated by gravimetric methods | 6 hours post delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients loss more than 1000 ml blood | calculate number of patients loss more than 1000 ml blood | 24 hours post delivery | 
| need of uterotonics | number of patients need of uterotonics | 24 hours post delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Hemorrhage, vaginal delivery, tranexamic acid, misoprostol