Post Partum Hemorrhage
Conditions
Keywords
Postpartum Hemorrhage, vaginal delivery, tranexamic acid, misoprostol
Brief summary
The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery
Detailed description
Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.
Interventions
DRUGmisoprostol
Patient receive 600mic gm sublingual misoprostol
DRUGCarbetocin
Patient receive 100 mic gm carbetocin IV
DRUGTA
The patient receives 1gm oral tranexamic acid
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study was a prospective double-blind randomized study
Intervention model description
This study was a prospective double-blind randomized study
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* All participants had PPH defined as vaginal bleeding\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.
Exclusion criteria
* were gestational age\<37 weeks, * genital tract trauma, * coagulation defect, * women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy * known hypersensitivity to carbetocin or oxytocin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the amount of blood loss | 6 hours post delivery | the amount of blood loss by gm calculated by gravimetric methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of patients loss more than 1000 ml blood | 24 hours post delivery | calculate number of patients loss more than 1000 ml blood |
| need of uterotonics | 24 hours post delivery | number of patients need of uterotonics |
Countries
Egypt
Outcome results
None listed