Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery
Paraules clau
Resum
Descripció
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.
Dates
| Darrera verificació: | 01/31/2019 |
| Primer enviat: | 12/13/2018 |
| Inscripció estimada enviada: | 12/13/2018 |
| Publicat per primera vegada: | 12/16/2018 |
| Última actualització enviada: | 02/13/2019 |
| Publicació de l'última actualització: | 02/17/2019 |
| Data d'inici de l'estudi real: | 12/31/2018 |
| Data estimada de finalització primària: | 12/30/2020 |
| Data estimada de finalització de l’estudi: | 01/30/2021 |
Condició o malaltia
Intervenció / tractament
Drug: Misoprostol
Drug: TA
Drug: placebo to Misoprostol and TA
Drug: Misoprostol with placebo to TA
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Active Comparator: Misoprostol with TA 400 μg of buccal misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout | |
| Active Comparator: Misoprostol with placebo to TA 400 μg of buccal misoprostol (two tablets) plus 110 ml saline by iv rout | Drug: Misoprostol with placebo to TA 110 ml saline iv |
| Placebo Comparator: placebo to Misoprostol and TA placebo to misoprostol plus placebo to tranexamic acid | Drug: placebo to Misoprostol and TA placebo tablets to misoprostol buccal |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | Female |
| Accepta voluntaris saludables | Sí |
| Criteris | 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 |
Resultat
Mesures de resultats primaris
1. estimation of intraoperative blood loss (ml) [during the operation]
Mesures de resultats secundaris
1. amount of postoperative blood loss [6 hours post operative]
2. number of patient with postpartum hemorrhage [24 hours post operative]
