Role of Tranexamic Acid Versus Uterine Cooling at Caesarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tranexamic Acid Versus Novel Uterine Cooling Technique in Reducing Blood Loss and Incidence of Postpartum Hemorrhage at Caesarean Section

Conditions
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Hemorrhage of Cesarean Section and/or Perineal Wound, Postpartum Hemorrhage, Uterine Atony

Intervention / Treatment
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* Drug: Tranexamic Acid
* Procedure: Intraoperative Uterine Cooling


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group (X) Prophylactic Tranexamic Acid<br>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). | Drug: Tranexamic Acid<br>* At 20 minutes preoperatively, TXA of 20 mg/kg was administered in Z Solution (500•0 ml normal saline containing a prophylactic antibiotic 1•0 g).<br>* Other names: TXA;|
| Experimental: Group (Y) Intraoperative Uterine Cooling<br>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]. | Procedure: Intraoperative Uterine Cooling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood loss volume | Estimation of Total Blood Loss Volume (ml) during CS and in the PACU. | Up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit value (Hct) | Estimating change in Pre- versus Post-operative hematocrit values (%) at 6 hours postoperatively. | 6 hours postoperative period | 
| Overall blood loss volume greater than 1000 cc | Estimation of overall blood loss volume during CS and up to 6 hours postoperatively | Up to 9 hours | 
| Need for Additional Ecbolics | Need for additional ecbolics to arrest and manage bleeding if there is a uterine atony | Intraoperative | 
| Need for other surgical measures to stop bleeding | Need for other surgical measures to stop bleeding (B-lynch denoting uterine atony, uterine artery ligation, hysterectomy) | Intraoperative | 
| Transfusion of Blood or Blood Products | Need for transfusion of blood or blood products during CS and in the PACU | Up to 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean Section, Tranexamic Acid, Postpartum Hemorrhage, Ecbolics