Plain English Summary
Background and study aims
Minimizing blood loss during delivery whether vaginal or abdominal is an important preventive health objective aimed at reducing related morbidities and mortality for which various interventions have been used to achieve this purpose however postpartum haemorrhage remains a major cause of maternal mortality especially in developing countries. The aim of this study is to determine the effect of Tranexamic acid on blood loss at Caesarean section.
Who can participate?
All pregnant women scheduled for a primary (singleton pregnancy) can participate.
What does the study involve?
Before undergoing Caesarean section particpants will be assigned to either recieve an injection of Tranexamic acid or placebo. The research participant, the individual(s) who administer the treatment, and the individual(s) who assess the outcomes will not know which treatment has been provided in order to make the study more accurate. During and after the procedure blood loss will be measured to assess which treatment is associated with less blood loss.
What are the possible benefits and risks of participating?
Participants blood level(PCV) will be checked at no cost before and after the procedure with closer monitoring of the participants and their babies before, during and after the procedure. You would be contributing to knowledge and helping us know how to further reduce bleeding in our women having caesarean delivery. Not all participants will receive Tranexamic acid, assuming you do common side effects include headaches however you will be on pain relief that will take care of this. Tranexamic acid is a category B drug which means animal studies have shown it is safe for the baby,not demonstrated in humans though,same group as heparin and common antibiotics used in pregnancy. Thromboembolic effects of tranexamic acid was only demonstrated at high recurrent doses which is higher than a single 1g dose you will be receiving during the study and those already with this risk will be excluded from the study.
Where is the study run from?
Irrua Specialist Teaching Hospital, Benin Auchi Expressway, Irrua, Edo State, Nigeria.
When is the study starting and how long is it expected to run for?
April 2019 to January 2020
Who is funding the study?
Irrua Specialist Teaching Hospital, Nigeria
Who is the main contact?
Dr. Olorungbogo Olugbenga, olorung@gmail.com
Trial website
Contact information
Type
Public
Primary contact
Dr Olorungbogo Olugbenga
ORCID ID
http://orcid.org/0000-0003-0085-2847
Contact details
Irrua Specialist Teaching Hospital
Benin Auchi Expressway
Irrua
310112
Nigeria
+2348064477268
olorung@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
00001
Study information
Scientific title
Efficacy of preoperative Tranexamic acid in reducing blood at Caesarean section; a randomized controlled trial at Irrua, Edo state.
Acronym
EPTAC
Study hypothesis
Preoperative tranexamic acid reduces blood loss at Caesarean section.
Ethics approval
Approved 26/01/2019, Ambrose Alli University, Ekpoma Health Research Ethics Committee (Irrua, Edo state, Nigeria; cle21200@gmail.com; +2347058777005), ref: NHREC/12/06/2013.
In collaboration with Irrua Specialist Teaching Hospital Research and Ethics Committee (Irrua, Edo State, Nigeria; isth.rec.2015@gmail.com)
Study design
Triple blind randomized placebo controlled trial.
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 contact details to request a participant information sheet.
Condition
Obstetric haemorrhage
Intervention
Preoperative intravenous tranexamic acid 1g(10mls) vs Preoperative intravenous water for injection (10mls) as placebo.
Randomization into groups is by simple balloting, drawing numbers from a ballot box.
Intervention type
Drug
Phase
Phase II
Drug names
Tranexamic Acid
Primary outcome measure
Blood loss at Caesarean section and within 24 hours after surgery using galvametric and volumetric approach of estimation.
Secondary outcome measures
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
Overall trial start date
15/09/2018
Overall trial end date
24/01/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All pregnant women scheduled for a primary Caesarean section
2. Singleton pregnancy
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
208
Total final enrolment
208
Participant 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.
Recruitment start date
01/04/2019
Recruitment end date
24/01/2020
Locations
Countries of recruitment
Nigeria
Trial participating centre
Irrua Specialist Teaching Hospital
Benin Auchi Expressway
Irrua
310112
Nigeria
Sponsor information
Organisation
Irrua Specialist Teaching Hospital
Sponsor details
Benin Auchi Expressway
Irrua
310112
Nigeria
+2348064477268
olorung@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Irrua Specialist Teaching Hospital (Nigeria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be published in a reputable international journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
25/04/2021
Participant level data
Other
Basic results (scientific)
Publication list