Cesarean Section Complications
Conditions
Keywords
cesarean section, tranexamic acid, misoprostol
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
Interventions
DRUGMisoprostol
two tablets misoprostol 400 μg sublingual
DRUGTranexamic Acid
two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline
DRUGplacebo to tranexamic acid
placebo to tranexamic acid (110 ml saline)
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used
Intervention model description
double-blind placebo randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients develop postpartum hemorrhage | 6 hours post operative | calculation of number of patients develop postpartum hemorrhage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss (ml) | during the operation | calculation of the amount of blood loss in ml by gravimetric methods |
Other
| Measure | Time frame | Description |
|---|---|---|
| postoperative blood loss (ml) | 6 hours post operative | calculation of the amount of blood loss in ml by gravimetric methods |
| number of patients need blood transfusion | 24 hours postoperative | calculation of number of patients need blood transfusion |
Countries
Egypt
Contacts
Primary Contacthany f sallam
Outcome results
None listed