Cesarean Section Complications
Conditions
Keywords
cesarean section, tranexamic acid, postpartum hemorrhage, misoprostol
Brief summary
Purpose to evaluate the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women with twin pregnancy undergoing an elective 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. Risk factors of uterine atony include obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis as well as a twin pregnancy. With the increasingly common use of ovulation induction and assisted reproduction techniques, the incidence of multiple gestation pregnancies has progressively increased. Suzuki et al reported that elective cesarean delivery of twin pregnancy at a gestational age of 37 weeks or greater may increase the risk of blood transfusion. Several uterotonic agents are used to prevent PPH because of uterine atony, including oxytocin, an ergot alkaloid, and prostaglandin. However, there are currently no data to evaluate the efficacy of co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on prevention of postpartum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean. therefore, this study was designed to evaluate and compare these two new therapeutic options in controlling PPH following CS for twin pregnancy
Interventions
DRUGMisoprostol
400 μg of sublingual misoprostol
DRUGTA
1 gm of tranexamic acid in 100 ml saline iv
placebo tablets to misoprostol subligual
DRUGplacebo to TA
110 ml saline iv
Sponsors
Aswan University Hospital
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
* women with a multiple term pregnancy undergoing elective cesarean section
Exclusion criteria
* single gestation * 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
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