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.: PACTR202211791554683 Date of Approval: 24/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFICACY OF TRANEXAMIC ACID IN REDUCING POSTPARTUM BLOOD LOSS FOLLOWING VAGINAL DELIVERY: A DOUBLE-BLIND PLACEBO CONTROLLED RANDOMIZED CLINICAL STUDY IN NAUTH, NNEWI
Official scientific title EFFICACY OF TRANEXAMIC ACID IN REDUCING POSTPARTUM BLOOD LOSS FOLLOWING VAGINAL DELIVERY: A DOUBLE-BLIND PLACEBO CONTROLLED RANDOMIZED CLINICAL STUDY IN NAUTH, NNEWI
Brief summary describing the background and objectives of the trial Postpartum haemorrhage is a leading cause of maternal morbidity and mortality in Africa and beyond. Despite the availability and use of numerous uterotonic agents, its incidence continues to be on the increase. The use of tranexamic acid has been shown to be safe and an effective option in the management of postpartum haemorrhage. However, the prophylactic benefit of tranexamic acid use in reducing postpartum blood loss has not been clearly established. OBJECTIVE The objective of this study is to evaluate the efficacy of tranexamic acid in reducing postpartum blood loss following vaginal delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Postpartum blood loss
Purpose of the trial Prevention
Anticipated trial start date 01/12/2022
Actual trial start date
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo Water for Injection 10ml of water for injection At time of delivery All the patients' in this arm will receive 10mls of water for injection as placebo at time of delivery alongside standard of care. 55 Placebo
Experimental Group Tranexamic Acid 1g of intravenous tranexamic acid At time of delivery All patients' in this arm will receive 1g of tranexamic acid at time of delivery alongside standard of care 55
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. 18years and above at time of consent 2. Singleton pregnancy 3. Term gestation ( ≥ 37 completed weeks) 1. Multiple pregnancy 2. History of eclampsia or pre-eclampsia in index pregnancy 3. Imminent delivery (<2 hours) from presentation 4. History of bleeding disorders 5. History of allergy to tranexamic acid Adult: 19 Year-44 Year 18 Year(s) 50 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 15/07/2022 Nnamdi Azikiwe University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Onitsha Road Nnewi 434116 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome measures will be the mean postpartum blood loss following vaginal delivery and haemoglobin change 48hours post-delivery.
Secondary Outcome Need for blood transfusion in the postpartum period 48 hours post delivery
Secondary Outcome Need for additional uterotonics 48 hours post delivery
Secondary Outcome Need for other surgical interventions for postpartum haemorrhage (such as B-lynch procedure, bilateral uterine artery ligation or hysterectomy) 48 hours post delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Onitsha Road Nnewi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nnaedozie Paul Obiegbu Ascension Villa Nnewi 434116 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nnaedozie Paul Obiegbu Ascension Villa Nnewi 434116 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Obinna Kenneth Nnabuchi Obiofia Nnewichi Nnewi 434116 Nigeria
Dr. George Uchenna Eleje Obiofia Nnewichi Nnewi 434116 Nigeria
Prof Okechukwu Christian Ikpeze Pioneer Street Onitsha 431102 Nigeria
Dr. Adaeze Chidinma Obiegbu Ascension Villa Nnewi 434116 Nigeria
Dr. Chigozie Geoffrey Okafor Otolo Nnewi 434116 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nnaedozie Obiegbu pobiegbu@icloud.com +2347038211980 Ascension Villa
City Postal code Country Position/Affiliation
Nnewi Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Adaeze Obiegbu omalichaada1@gmail.com +2347067014836 Ascension Villa
City Postal code Country Position/Affiliation
Nnewi Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries George Eleje georgel21@yahoo.com +2348068117444 Obiofia Nnewichi
City Postal code Country Position/Affiliation
Nnewi Nigeria Head of Department
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 deindentification Study Protocol Immediately following publication, no end date beginning 3 months and ending 5 years Not Applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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