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NCT Number: NCT02739815

Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section

This study aims to define a safe prophylactic intravenous TXA dose with an advantage over others in reducing total blood loss volume at secondary uncomplicated LSCS.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Al-Azhar University, Faculty of Medicine for Boys ( Cairo ), Al-Hussein University Hospital

Cairo, Cairo Governorate, Egypt

About this study

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,10 as an antifibrinolytic agent it has roughly eight times the antifibrinolytic activity of an older analogue; ε-aminocaproic acid. It competitively inhibits the activation of plasminogen to plasmin, by binding to specific sites of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clots. 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. No defined safe prophylactic intravenous TXA dose being found in searching literature having an advantage over other doses in reducing total blood loss especially at secondary uncomplicated LSCS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Maternal average age of 20-40 years.
  • Singleton pregnancy at term between 38±5 days and 40 weeks.
  • Elective planned or emergency secondary lower segment caesarean sections (LSCS).

Exclusion criteria

  • Women with severe medical and surgical complications as any of the following will be excluded :
  • Heart, liver, kidney, or brain diseases, and blood disorders.
  • Abruptio placenta, and placental abnormalities or accrete syndromes.
  • Polyhydramnios, macrosomia, preeclampsia, or allergy to tranexamic acid.
  • History of thromboembolic disorders, or severe anemia.

Treatment and study plan

Normal Saline containing a prophylactic Antibiotic 1 g

Drug

500 ml of normal saline containing a prophylactic Antibiotic 1 g.

Other names: Solution of Sodium Chloride 0.9 %

Tranexamic Acid

Drug

Tranexamic acid

Other names: TXA

Primary outcomes

  1. Total Blood Loss Volume

    Time frame: Up to 7 hours

    Estimating Total Blood Loss Volume (ml) during and after Caesarean Section, up to 6 hours post-operative.

Secondary outcomes

  1. Duration of surgery

    Time frame: Up to One hour

    Duration of Caesarean Section estimating (min)

  2. Hemoglobin level (Hb)

    Time frame: 6 hours

    6 hours post-operative hemoglobin level (mg/dL) estimating.

  3. Maternal weight (W)

    Time frame: 2 hours

    2 hours post-operative maternal weight (kg) estimating

  4. Hematocrit value (Hct)

    Time frame: 6 hours

    6 hours post-operative hematocrit value (%) estimating.

  5. Need for blood or blood products transfusion

    Time frame: Up to 6 hours

    Need for other medical measures to arrest and manage bleeding (transfusion of blood or blood products)

  6. Need for additional ecbolics

    Time frame: Up to 6 hours

    Need for other medical measures to arrest and manage bleeding if there is a uterine atony (more than five units of intravenous Syntocinon®)

  7. Need for hysterectomy

    Time frame: Up to 6 hours

    Need for other surgical measures to arrest and manage bleeding (Hysterectomy)

  8. Need for uterine artery ligation

    Time frame: Up to 6 hours

    Need for other surgical measures to arrest and manage bleeding (Uterine artery ligation)

  9. Need for B-lynch

    Time frame: Up to 6 hours

    Need for other surgical measures to arrest and manage bleeding if there is a uterine atony (B-lynch)

  10. APGAR Score

    Time frame: Up to 30 minutes

    APGAR Score as index for any neonatal side effects of medications given

  11. Any sign for developing a thromboembolic disorder (Maternal)

    Time frame: One week

    As index for any maternal side effects of medications given

  12. Blood pressure

    Time frame: Up to 2 hours

    Measuring maternal blood pressure (mmHg) immediately postoperative and after 2 hours postoperative.

  13. Pulse rate

    Time frame: Up to 2 hours

    Measuring maternal blood puse rate (/minute) immediately postoperative and after 2 hours postoperative.

Sponsors and collaborators

Lead sponsor

Talkha Central Hospital

Other Gov

Collaborators

  • Al-Azhar University

Registry information

Official study title

Comparative Study For Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section: A Randomised Controlled Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2016
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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