Clinical trial NCT02780245: Role of Tranexamic Acid Versus Uterine Cooling at Caesarean Section
Official title: Tranexamic Acid Versus Novel Uterine Cooling Technique in Reducing Blood Loss and Incidence of Postpartum Hemorrhage at Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhage of Cesarean Section and/or Perineal Wound
Postpartum Hemorrhage
Uterine Atony
Keywords: Caesarean Section
Tranexamic Acid
Postpartum Hemorrhage
Ecbolics
Lead sponsor: Talkha Central Hospital
Sponsor class: OTHER_GOV
First posted: 2016-05-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Total blood loss volume
timeFrame: Up to 3 hours
Secondary outcomes:
measure: Hematocrit value (Hct)
timeFrame: 6 hours postoperative period
measure: Overall blood loss volume greater than 1000 cc
timeFrame: Up to 9 hours
measure: Need for Additional Ecbolics
timeFrame: Intraoperative
measure: Need for other surgical measures to stop bleeding
timeFrame: Intraoperative
measure: Transfusion of Blood or Blood Products
timeFrame: Up to 3 hours
Other outcomes:
measure: Blood Pressure
timeFrame: Up to 3 hours
measure: Maternal Side effects of intervention administered
timeFrame: Up to 9 hours
measure: APGAR Scores
timeFrame: up to 2 hours
measure: Pulse Rate
timeFrame: Up to 3 hours
Locations:
city: Mansoura
country: Egypt
facility: Talkha Central Hospital
state: Al-Dakahliya
Study officials:
affiliation: Talkha Central Hospital
name: Amro M Hetta, M.B., Ch.B.
role: PRINCIPAL_INVESTIGATOR
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