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

NCT ID: NCT03774706

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-01-31

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

Conditions

Cesarean Section Complications

Study Design

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

Study Groups

Misoprostol with TA

two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

two tablets misoprostol 400 μg sublingual

Tranexamic Acid

Intervention Type: DRUG

two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline

Misoprostol with placebo to TA

two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

two tablets misoprostol 400 μg sublingual

placebo to tranexamic acid

Intervention Type: DRUG

placebo to tranexamic acid (110 ml saline)

Interventions

Misoprostol

two tablets misoprostol 400 μg sublingual

Intervention Type: DRUG

Tranexamic Acid

two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline

Intervention Type: DRUG

placebo to tranexamic acid

placebo to tranexamic acid (110 ml saline)

Intervention Type: DRUG

Other Intervention Names

Active Comparator; active comparator; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f sallam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

hany f sallam

Role: CONTACT

hany.farouk@aswu.edu.eg

01022336052 ext. 002

Facility Contacts

hany f sallam, md

Role: primary

nahla.elsayed@aswu.ed.eg

01092440504 ext. 002

Nahla w Shady, md

Role: backup

nahla.elsayed@aswu.edu.eg

1019240504 ext. 002

Other Identifiers

aswu/184/18

Identifier Type: -

Identifier Source: org_study_id