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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774706
• Other study ID #: aswu/184/18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2019
• Source: Aswan University Hospital
• Contact: hany f sallam
• Phone: 01022336052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 31, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• Misoprostol
two tablets misoprostol 400 µg sublingual
• Tranexamic Acid
two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline
• placebo to tranexamic acid
placebo to tranexamic acid (110 ml saline)

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative blood loss (ml)	calculation of the amount of blood loss in ml by gravimetric methods	6 hours post operative
Other	number of patients need blood transfusion	calculation of number of patients need blood transfusion	24 hours postoperative
Primary	number of patients develop postpartum hemorrhage	calculation of number of patients develop postpartum hemorrhage	6 hours post operative
Secondary	intraoperative blood loss (ml)	calculation of the amount of blood loss in ml by gravimetric methods	during the operation