Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108668389918 Date of Approval: 24/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title impact of tranexamic acid on the prevention of during and post-caesarean hemorrhage
Official scientific title impact of tranexamic acid on the prevention of hemorrhage during and after cesarean section in parturients at risk.
Brief summary describing the background and objectives of the trial Postpartum hemorrhage (PPH) is a major cause of maternal morbidity and mortality worldwide. Cesarean section rates have increased resulting in an increased incidence of PPH. Although all women are vulnerable to PPH, the presence of risk factors increases the likelihood of it. The prophylaxis of PPH seems to us to be a major objective of its management, the administration of uterotonic allows a mechanical improvement of hemostasis, a complementary biochemical hemostatic effect could be reinforced by tranexamic acid (ATX). antifibrinolytic which has widely demonstrated its efficacy as a pharmacological means of perioperative blood sparing; in particular in the field of cardiac hemorrhagic surgery, orthopedic surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Obstetrics and Gynecology,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied post partum hemorhage
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/09/2019
Actual trial start date 19/09/2019
Anticipated date of last follow up 08/08/2021
Actual Last follow-up date 19/09/2021
Anticipated target sample size (number of participants) 796
Actual target sample size (number of participants) 800
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group tranexamic acid prophylaxis to reduce postpartum hemorrhage in vulnerable parturients 1g tranexamic acid in 20ml saline by slow intravenous injection, 15 min before the surgical incision. 3 years Random allocation of the treatment to be received by the parturients will be done by the method of random draw. The trial will be double-blind, the patient and the physician in charge of the anesthesia and the collection of the primary and secondary endpoints will not know which the patient has received: tranexamic acid or placebo. After the informed consent of the parturients, the syringes will be prepared and labeled by the person in charge of randomization, according to the number of the envelope as follows: in the tranexamic acid group, which will receive 1g diluted in 20ml of saline, and, the administration will be done by slow intravenous route over 5 min, within 15 min before the surgical incision. 800
Control Group intervention without active ingredient or therapeutic effect 20ml of saline in slow intravenous route, 15 min before the surgical incision. 3 years The trial will be double-blind, the patient and the physician in charge of the anesthesia and the collection of the primary and secondary endpoints will not know which the patient has received: tranexamic acid or placebo. After the informed consent of the parturients, the syringes will be prepared and labeled by the person in charge of randomization, according to the number of the envelope as follows. In the placebo group 20ml of SSI, the administration will be done by slow intravenous route over 5 min, within 15 min before the surgical incision. 800 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Scheduled or semi-emergency cesarean section. - Live fetus. - Gestational age greater than or equal to 35 SA. - Parturients classified as ASA I or ΙІ,consenting, with 2 or more risk factors for postpartum hemorrhage: * polyhydramnios. * age greater than 35 years. * Fetal macrosomia. * coagulation anomaly. * thrombopenia. * anticoagulant treatment. * antecedents of postpartum hemorrhage. * placenta pravea not recovering. * Anemia. * Pre-eclampsia. * Multiple pregnancy. * Multiple pregnancy. * Chorioamniotitis. - Allergy to tranexamic acid. - Severe renal impairment. - History of thrombosis. - Epilepsy. - Death in utero - Severe medical or surgical complication involving the heart, liver, kidneys, or brain. - Placental insertion anomalies: placenta accreta and covering pravea. - Caesarean sections performed for active bleeding during uterine rupture, retro placental hematoma, or placenta previa. Adult: 19 Year-44 Year 18 Year(s) 46 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/07/2019 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Street Said Touati Bab El Oued Algiers 16000 Algeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome There was statistically significant reduction in the mean blood loss among the study group who received tranexamique acid in comparison to the control group Blood loss was measured from the beginning of the skin incision until the end of the cesarean section, then 2 h and 24 h later of the postpartum.
Secondary Outcome no major side effects from injection to 42 days postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University hospital Lamine baghine street said touati - Bab El Oued Algiers 16000 Algeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Hadbi Mohamed Street Said Touati, Bab El Oued Algiers 16000 Algeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University Hospital Lamine Debaghine Bab El Oued Street Said Touati, Bab El Oued Algiers 16000 Algeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Fellah Nadia Street Said Touati, BabEl Oued Algiers 16000 Algeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hadbi Mohamed hadbimohamed@hotmail.fr +213550738905 Street Said Touati, Bab El Oued.
City Postal code Country Position/Affiliation
Algiers 16000 Algeria researcher
Role Name Email Phone Street address
Scientific Enquiries Nadia Fellah nfellah2012@gmail.com +21321960606 Street Said Touati, Bab El Oued
City Postal code Country Position/Affiliation
Algiers 16000 Algeria professor head of the department of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries houda Ghabouli houdadoudada@gmail.com +21323156680 Street Said Touati, Bab El Oued
City Postal code Country Position/Affiliation
Algiers 16000 Algeria resident physician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification (text, tables, figures, and appendices). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 3 years - Open Access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://orcid.org/0000-0002-2880-4452 No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information