Intravenous tranexamic acid use in elective caesarean section: Does it reduce blood loss?
| ISRCTN | ISRCTN42314355 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42314355 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/08/2009
- Registration date
- 18/09/2009
- Last edited
- 13/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gokhan Yildirim
Scientific
Scientific
Atakent Mah. Soyak Olypiakent Sitesi D10-57
K.Cekemece
Istanbul
34303
Türkiye
| gokhan73yildirim@gmail.com |
Study information
| Study design | Prospective randomised double-blind placebo controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Intravenous tranexamic acid use in elective caesarean section: Does it reduce blood loss? A prospective randomised double-blind placebo controlled study |
| Study objectives | 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(s) | Istanbul Bakirkoy Women and Children Hospitals Local Ethics Board approved on the 18th March 2009 (ref: 185) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Transexamic acid (TA) |
| Primary outcome measure | 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 study start date | 01/06/2009 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 660 |
| Key inclusion criteria | 1. Subjects older than 38 weeks estimated gestational age 2. Requiring elective caesarean section 3. Females aged 20 - 40 years |
| Key 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 |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Atakent Mah. Soyak Olypiakent Sitesi D10-57
Istanbul
34303
Türkiye
34303
Türkiye
Sponsor information
Istanbul Bakirkoy Women and Children Hospital (Turkey)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynecology
Istanbul
34720
Türkiye
Funders
Funder type
Hospital/treatment centre
Istanbul Bakirkoy Women and Children Hospital (Turkey) - Department of Obstetrics and Gynecology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
