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Intravenous tranexamic acid use in elective caesarean section: Does it reduce blood loss?

Intravenous tranexamic acid use in elective caesarean section: Does it reduce blood loss? A prospective randomised double-blind placebo controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN42314355
Enrollment
660
Registered
2009-09-18
Start date
2009-06-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective caesarean section Pregnancy and Childbirth Caesarean section

Interventions

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 b

Sponsors

Istanbul Bakirkoy Women and Children Hospital (Turkey)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Subjects older than 38 weeks estimated gestational age 2. Requiring elective caesarean section 3. Females aged 20 - 40 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Quantity of blood postpartum, measured from one day before the caesarean section and two days after the caesarean section

Secondary

MeasureTime frame
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

Countries

Turkey

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026