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Use of tranexamic acid for the prevention of blood loss in cesarean delivery: the EPTAC trial

Efficacy of preoperative Tranexamic acid in reducing blood at Caesarean section; a randomized controlled trial at Irrua, Edo state.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11204890
Enrollment
208
Registered
2019-04-04
Start date
2019-04-01
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Obstetric haemorrhage Pregnancy and Childbirth

Interventions

Preoperative intravenous tranexamic acid 1g(10mls) vs Preoperative intravenous water for injection (10mls) as placebo. Randomization into groups is by simple balloting, drawing numbers

Sponsors

Irrua Specialist Teaching Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. All pregnant women scheduled for a primary Caesarean section 2. Singleton pregnancy

Exclusion criteria

Exclusion criteria: 1. Multiple gestation 2. Any other additional risk of bleeding apart from the Caesarean section such as previous caesarean section, antepartum haemorrhage, polyhydramnios and bleeding disorders. 3. Liver or Renal pathologies 4. Patients who chose not to participate in the study. 5. Allergy to Tranexamic acid 6. Women unfit to give an informed consent e.g. the eclamptic, unconscious or those with mental impairment.

Design outcomes

Primary

MeasureTime frame
Blood loss at Caesarean section and within 24 hours after surgery using galvametric and volumetric approach of estimation.

Secondary

MeasureTime frame
1. The difference in 1hr preoperative packed cell volume and 48hrs postoperative packed cell volume. 2. Additional oxytocic requirement, blood transfusion, caesarean hysterectomy or maternal death as a result of primary Post Partum Haemorrhage. 3. APGAR scores in first and fifth minutes and Neonatal Intensive care unit admissions/outcome. 4. Maternal satisfaction prior to discharge measured using a scale of 0-10; Where 0- extreme dissatisfaction and 10-ultimate satisfaction

Countries

Nigeria

Contacts

Public ContactOlorungbogo Olugbenga
olorung@gmail.com+2348064477268

Outcome results

None listed

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