Condition category
Pregnancy and Childbirth
Date applied
15/03/2019
Date assigned
04/04/2019
Last edited
26/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

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

Publication citations

Additional files

Editorial Notes