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

Not Applicable

• Conditions: Cesarean Section Complications
• Interventions: Drug: Misoprostol; Drug: placebo to tranexamic acid; Drug: Tranexamic Acid

• Registration Number: NCT03774706
• Lead Sponsor: Aswan University Hospital

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Study Start: 2019-01-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol with placebo to TA	placebo to tranexamic acid	two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv
Misoprostol with TA	Misoprostol	two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv
Misoprostol with TA	Tranexamic Acid	two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv
Misoprostol with placebo to TA	Misoprostol	two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv

Primary Outcome Measures

Name	Time	Method
number of patients develop postpartum hemorrhage	6 hours post operative	calculation of number of patients develop postpartum hemorrhage

Secondary Outcome Measures

Name	Time	Method
intraoperative blood loss (ml)	during the operation	calculation of the amount of blood loss in ml by gravimetric methods

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt