Sublingual Misoprostol With or Without Intravenous Tranexamic Acid During Hemorrhagic Cesarean Section

Study Overview
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Brief Summary
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Purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean section.

Detailed Description
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Different uterotonic agents administration, mainly oxytocin, has been routinely used to reduce the frequency of cesarean section (CS) -related hemorrhage; however, some studies reported that oxytocin use in the setting of CS may result in maternal adverse effects, including hypotension and tachycardia., Therefore, investigating other therapeutic agents with lower adverse effects and higher efficacy is needed. Recently, a number of studies reported a correlation between fibrinogen decrease and cesarean-related hemorrhage. Furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic equilibrium and contributing to bleeding. Therefore, anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of postpartum hemorrhage (PPH) in females after vaginal or elective CS verse effects and higher efficacy is needed. Moreover, misoprostol is a prostaglandin E1 analog which has been introduced as a uterotonic agent for preventing PPH following CS. A recent study reported that oral or sublingual misoprostol is more effective than the placebo in reducing severe PPH, following CS

Official Title
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Role of Sublingual Misoprostol With or Without Intravenous Tranexamic Acid for Reducing Post-partum Hemorrhage During and After Hemorrhagic Cesarean Section: A Double-Blind Randomized Clinical Trial

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Tranexamic Acid
* Drug: placebo to tranexamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women who undergone elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus age between 18 and 45 years, gestational age of 37-40 weeks, singleton pregnancy, CS with inferior segment incision, and spinal anesthesia. Exclusion Criteria: having an underlying disease (heart, liver, kidney, pulmonary, etc.), eclampsia and severe preeclampsia allergy to TA (such as known allergy or thromboembolic event during pregnancy) and misoprostol coagulation disorders refuse or unable to consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blind placebo randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol with TA<br>two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv | Drug: Misoprostol<br>* two tablets misoprostol 400 μg sublingual<br>* Other names: Active Comparator;Drug: Tranexamic Acid<br>* two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline<br>* Other names: active comparator;|
| Active Comparator: Misoprostol with placebo to TA<br>two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv | Drug: Misoprostol<br>* two tablets misoprostol 400 μg sublingual<br>* Other names: Active Comparator;Drug: placebo to tranexamic acid<br>* placebo to tranexamic acid (110 ml saline)<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients develop postpartum hemorrhage | calculation of number of patients develop postpartum hemorrhage | 6 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss (ml) | calculation of the amount of blood loss in ml by gravimetric methods | during the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, tranexamic acid, misoprostol