Cesarean Section Complications
Conditions
Keywords
cesarean section, tranexamic acid, postpartum hemorrhage, oxytocin
Brief summary
Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section
Detailed description
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. The aim of the study is to To explore the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD), compared with placebo.
Interventions
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
DRUGnormal saline
2 placebo ampoules to TA in 100 ml saline by slow infusion
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
open label Randomized Clinical Tria
Intervention model description
open label Randomized Clinical Tria
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml
Exclusion criteria
* placenta praevia and placental abruption * Women with a medical disorder, * placenta accrete, * allergy to TA, and * intraoperative bleeding thanks to causes aside from uterine atony * Patients over 40 or who have * pre-existing coagulation disorders, * with a severe medical disorder * allergy to tranexamic acid * refuse to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients need of additional pharmacological uterotonic | 24 hours post operative | calculation number of patients need of additional pharmacological uterotonic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| estimation of intraoperative blood loss (ml) | during the operation | measure Intraoperative blood loss in ml by gravimetric methods |
| amount of postoperative blood loss | 4 hours postoperative | measure amount of blood loss post operative in ml by gravimetric methods |
| number of patient with postpartum hemorrhage | 24 hours post operative | calculation of the number of the patients with blood loss \>1000 ml |
Countries
Egypt
Outcome results
None listed