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

Aswan University Hospital

Status: Unknown

Conditions: Cesarean Section Complications

Treatments: Drug: Tranexamic Acid; Drug: placebo to tranexamic acid; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03774706

aswu/184/18

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Misoprostol with TA

Active Comparator group

Description:

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

Treatment:

Drug: Misoprostol

Drug: Tranexamic Acid

Misoprostol with placebo to TA

Active Comparator group

Description:

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

Treatment:

Drug: Misoprostol

Drug: placebo to tranexamic acid