Tranexamic Acid Versus Novel Uterine Cooling Technique in Reducing Blood Loss and Incidence of Postpartum Hemorrhage at Caesarean Section
| Registry | NCT02780245 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; non randomized, parallel, masking: single, prevention |
| Enrollment | 100 (Actual) |
| Sponsor | Talkha Central Hospital (Other gov) |
| Conditions | Hemorrhage of Cesarean Section and/or Perineal Wound, Postpartum Hemorrhage, Uterine Atony |
| Interventions | Tranexamic Acid, Intraoperative Uterine Cooling (Drug, procedure) |
| Dates | start 2016-06-01, primary completion 2016-08-01, completion 2016-09-01, first posted 2016-05-23, last updated 2016-09-05 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Hemorrhage of Cesarean Section and/or Perineal Wound All trials for Postpartum Hemorrhage All trials of Tranexamic Acid All trials of Intraoperative Uterine Cooling
This study aims to compare role of a prophylactic predefined intravenous Tranexamic Acid dose versus intraoperative Uterine Cooling in reducing blood loss and incidence of postpartum hemorrhage at secondary CS.
Bleeding during vaginal or operative delivery is always of prime concern. Despite significant progress in obstetric care 125,000 women die from obstetric hemorrhage annually in the world.
The incidence of CS is increasing, and the average blood loss during CS (1000 mL) is double the amount lost during vaginal delivery (500 mL). CS rate as high as 25-30% in many areas of the world. In Egypt the CS rate is 27.6 %, in United States of America, from 1970-2009 the CS rate rose from 4.5-32.9%, and declined to 32.8% of all deliveries at 2010. In spite of the various measures to prevent blood loss during and after CS, post-partum hemorrhage (PPH) continues to be the most common complication seen in almost 20% of the cases, and causes approximately 25% of maternal deaths worldwide, leading to increased maternal morbidity and mortality. Women who undergo a CS are much more likely to be delivered by a repeat operation in subsequent pregnancies. For women undergoing subsequent CS, the maternal risks are even greater like massive obstetric hemorrhage, hysterectomy, admission to an intensive care unit, or maternal death. Medications, such as oxytocin, misoprostol and prostaglandin F2α, have been used to control bleeding postoperatively.
TXA is a synthetic analog of the amino acid lysine, as an antifibrinolytic agent. Its intravenous administration has been routinely used for many years to reduce or prevent excessive hemorrhage in various medical conditions or disorders (helping hemostasis), also during and after surgical procedures like benign hysterectomy, open heart surgeries, scoliosis surgery, oral surgery, liver surgeries, total hip or knee arthroplasty, and urology. It has been shown to be very useful and efficient in reducing blood loss and incidence of blood transfusion in these surgeries, and decreases the risk of death in bleeding trauma patients. It was also included in the World Health Organization (WHO) Model List of Essential Medicines.
About its role in CS, some recent studies showed that TXA has advantage and useful effect safely in reducing blood loss and requirement of additional ecbolics. Its doses used intravenously to reduce blood loss at CS were a bolus of 1gm, 10 mg/kg , or 15 mg/kg which had an advantage over 10 mg/kg in anemic parturients.
A recent study by Mitchell et al. concluded that Uterine cooling during cesarean delivery was efficient enough to decrease blood loss and the incidence of postpartum hemorrhage.
This study aims to compare role of a prophylactic predefined intravenous Tranexamic Acid dose versus intraoperative Uterine Cooling in reducing blood loss and incidence of postpartum hemorrhage at secondary CS.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group (X) Prophylactic Tranexamic Acid | Experimental | Drug: Tranexamic Acid | Intravenously at 20 minutes preoperatively had an intervention of a single bolus TXA dose of 20•0 mg/kg, which was administered in Z solution (500•0 ml normal saline containing a prophylactic antibiotic 1•0 g) (NCT02739815). |
| Group (Y) Intraoperative Uterine Cooling | Experimental | Procedure: Intraoperative Uterine Cooling | Firstly intravenously at 20 minutes preoperatively had only the Z solution, and secondly \[Intraoperatively immediately following delivery of the fetus the uterus was been externalized in the usual fashion, and the body of the uterus cephalad to the hysterotomy incision was been wrapped in sterile surgical towels saturated in sterile and iced normal saline. These towels came from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels was been kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen\]. |
Sex: Female, ages: 20 Years to 40 Years, accepts healthy volunteers
Inclusion Criteria: * Women who attended Talkha Central Hospital for planned or emergency secondary CS. * Singleton pregnancy at term with gestational age (G.A) between 38±5 and 40 weeks. Exclusion Criteria: * Preoperative exclusion criteria were women who had any disorders of heart, liver, kidney, brain or blood, Abruptio placenta, placental abnormalities or accrete syndromes, Polyhydramnios, macrosomia, preeclampsia, allergy to TXA, history of thromboembolic disorders, or severe anemia. * Intraoperative exclusion criteria was inability to exteriorize the uterus during CS for group (Y).
| Facility | City | Country | Status |
|---|---|---|---|
| Talkha Central Hospital | Al Mansurah, Al-Dakahliya | Egypt |