se of tranexamic acid for the prevention of blood loss in cesarean delivery: the EPTAC trial
Phase 2
Completed
- Conditions
- Obstetric haemorrhagePregnancy and Childbirth
- Registration Number
- ISRCTN11204890
- Lead Sponsor
- Irrua Specialist Teaching Hospital
- Brief Summary
2021 Results article in https://drive.google.com/file/d/1DmGJskKwH1g2TF6N6w5BgFf_tem-ONpg/view?usp=sharing (added 28/12/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 208
Inclusion Criteria
1. All pregnant women scheduled for a primary Caesarean section
2. Singleton pregnancy
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood loss at Caesarean section and within 24 hours after surgery using galvametric and volumetric approach of estimation.
- Secondary Outcome Measures
Name Time Method <br> 1. The difference in 1hr preoperative packed cell volume and 48hrs postoperative packed cell volume.<br> 2. Additional oxytocic requirement, blood transfusion, caesarean hysterectomy or maternal death as a result of primary Post Partum Haemorrhage.<br> 3. APGAR scores in first and fifth minutes and Neonatal Intensive care unit admissions/outcome.<br> 4. Maternal satisfaction prior to discharge measured using a scale of 0-10; Where 0- extreme dissatisfaction and 10-ultimate satisfaction<br>