Cesarean Section Complications
Conditions
Keywords
cesarean section, tranexamic acid, postpartum hemorrhage, misoprostol
Brief summary
Purpose to evaluate the effects of buccal misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women undergoing emergent cesarean section
Detailed description
The American Congress of Obstetricians and Gynecologists (ACOG) defines postpartum hemorrhage (PPH) as the loss of more than 1,000 mL after cesarean delivery. In the majority of cases, uterine atony is responsible for the occurrence of excessive bleeding during or following childbirth. The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond the investigator reach unless prioritize the prevention and treatment of PPH in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) has become essential to diminish the risk of PPH and improve maternal safety. Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer. Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CS has not been investigated as much.T he buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration. 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 PPH in females after vaginal or elective CS. The investigators designed this study to evaluate and compare these two new therapeutic options in controlling PPH following emergent CS.
Interventions
DRUGMisoprostol
400 μg of buccal misoprostol
DRUGTA
1 gm of tranexamic acid in 100 ml saline iv
placebo tablets to misoprostol buccal
DRUGplacebo to TA
110 ml saline iv
Sponsors
hany farouk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
a double-blinded randomized placebo-controlled trial
Intervention model description
A Double-Blind Randomized Clinical Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* age \>18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor
Exclusion criteria
* multiple gestations * placenta praevia and placental abruption * undergoing cesarean section with general anesthesia * women undergoing cesarean section at less than 37 weeks of gestation--with a severe medical disorder * allergy to tranexamic acid or misoprostol * refuse to consent * elective cesarean section
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| estimation of intraoperative blood loss (ml) | during the operation | measure Intraoperative blood loss in ml by gravimetric methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| amount of postoperative blood loss | 6 hours post operative | 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
Contacts
Primary Contacthany f sallam, md
Outcome results
None listed