Contact information
Type
Scientific
Primary contact
Dr Gokhan Yildirim
ORCID ID
Contact details
Atakent Mah. Soyak Olypiakent Sitesi D10-57
K.Cekemece
Istanbul
34303
Turkey
gokhan73yildirim@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Intravenous tranexamic acid use in elective caesarean section: Does it reduce blood loss? A prospective randomised double-blind placebo controlled study
Acronym
Study hypothesis
We know that, during delivery, when the placenta separates from the uterine wall, the fibrinolytic activation of the maternal blood increases and this tends to reduce the potential of blood to clot. This activation can last up to 6 - 10 hours postpartum, causing more bleeding. According to this activation of the fibrinolytic system, we decided to use transexamic acid (TA) to reduce the blood loss in the management of elective caesarean section (C/S) because TA inhibits this activation, thereby reducing bleeding.
As of 13/04/2010 this record was updated to include an amendment to the anticipated start date of this trial. The initial anticipated start date provided at the time of registration was 01/05/2009.
Ethics approval
Istanbul Bakirkoy Women and Children Hospitals Local Ethics Board approved on the 18th March 2009 (ref: 185)
Study design
Prospective randomised double-blind placebo controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Elective caesarean section
Intervention
Following informed consent, simple randomisation using a random number table was performed by the investigational pharmacy staff. Infusion bags were prepared in accordance with randomisation and the bags labeled as A or B. One bag contained 1 g/10 mL tranexamic acid (Transamin, Fako Ilaclari A.S. Istanbul) diluted with 20 mL of 5 % glucose (Bag A, tranexamic group). The other bag contained only 20 mL of 5 % glucose (Bag B, placebo group).
Bag A was administered at least 10 minutes prior to skin incision (tranexamic acid 1 g/10 mL was given slowly intravenously over 5 minutes). After delivery of the neonate, 5 IU i.v. bolus of pre-prepared oxytocin was given by the anaesthetis. Then, 30 IU oxytocin in 500 mL of lactated Ringer's solution at a rate of 125 mL/h which was continued for 4 hours were given. An antibiotic, 1 g cefazolin diluted in 20 mL normal saline, was administered over a 5-minute period.
In the placebo group, 10 minutes before taking the skin incision 20 mL of 5% glucose was given slowly intravenously over 5 minutes. After delivery of the neonate, 5 IU i.v. bolus of pre-prepared oxytocin was given by the anaesthetist. Then, 30 IU oxytocin in 500 mL of lactated Ringer's solution at a rate of 125 mL/h which was continued for 4 hours were given. An antibiotic, 1 g cefazolin diluted in 20 mL normal saline, was administered over a 5-minute period. All caesarean sections were performed under general anaesthesia.
Intervention type
Drug
Phase
Phase I
Drug names
Transexamic acid (TA)
Primary outcome measures
Quantity of blood postpartum, measured from one day before the caesarean section and two days after the caesarean section
Secondary outcome measures
Measured from one day before the caesarean section and two days after the caesarean section:
1. Excessive bleeding rate
2. Blood transfusion
3. The use of additional uterotonic agents reflecting atony (such as an oxytocin infusion or Prostaglandin F2a)
4. Incidence of tranexamic acid side effects
5. Post-natal length of stay for the mother
6. Neonatal outcomes
Overall trial start date
01/06/2009
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Subjects older than 38 weeks estimated gestational age
2. Requiring elective caesarean section
3. Females aged 20 - 40 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
660
Participant exclusion criteria
Any risk factor associated with an increased risk of postpartum haemorrhage:
1. Anaemia (Hb less than 7 g%)
2. Multiple gestation
3. Antepartum haemorrhage
4. Uterine fibroids
5. Polyhydramnios
6. Emergency caesarean section
7. A history of uterine atony and postpartum bleeding
8. Current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy
Recruitment start date
01/06/2009
Recruitment end date
30/09/2009
Locations
Countries of recruitment
Turkey
Trial participating centre
Atakent Mah. Soyak Olypiakent Sitesi D10-57
Istanbul
34303
Turkey
Funders
Funder type
Hospital/treatment centre
Funder name
Istanbul Bakirkoy Women and Children Hospital (Turkey) - Department of Obstetrics and Gynecology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary