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.: PACTR202011872201172 Date of Approval: 20/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF INTRAVENOUS TRANEXAMIC ACID IN REDUCING BLOOD LOSS DURING AND AFTER ELECTIVE CAESAREAN SECTION IN THE UNIVERSITY OF PORT HARCOURT TEACHING HOSPITAL: A RANDOMIZED CONTROLLED STUDY
Official scientific title EFFECT OF INTRAVENOUS TRANEXAMIC ACID IN REDUCING BLOOD LOSS DURING AND AFTER ELECTIVE CAESAREAN SECTION IN THE UNIVERSITY OF PORT HARCOURT TEACHING HOSPITAL: A RANDOMIZED CONTROLLED STUDY
Brief summary describing the background and objectives of the trial Blood loss during caesarean section leads to postpartum haemorrhage, which is among the leading causes of maternal mortality/morbidity in the UPTH. At UPTH, intravenous Tranexamic acid is not used prophylactically to reduce blood loss during/after CS despite evidence from studies done in centres abroad. Objective is to compare the blood loss during and after elective CS, need for additional uterotonics, blood transfusion, surgical interventions, and adverse maternal effects and perinatal outcome
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 Blood loss during and after caesarean section
Purpose of the trial Prevention
Anticipated trial start date 01/06/2020
Actual trial start date 01/07/2020
Anticipated date of last follow up 01/11/2020
Actual Last follow-up date 01/01/2021
Anticipated target sample size (number of participants) 148
Actual target sample size (number of participants) 148
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intravenous tranexamic acid 1 gram start (single dose) Each package will contain intravenous tranexamic acid which will be prepared by the investigator as a colourless fluid which will contain tranexamic acid at 1g (in 10 ml) diluted in 10 ml of water for injection to constitute 20ml of dilute TXA 74
Control Group placebo 20ml of water solution for injection Start (single dose) Each package will contain 20ml of water solution for injection which will be prepared by the investigator as a colourless fluid. 74 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 20 to 40 years. Parity- 1 - 4 Gestational age of 37-40 weeks. Singleton live fetus with reassuring fetal heart rate. Elective repeat CS. Refusal of the patient to give consent. Known allergy to intravenous tranexamic acid. Multiple pregnancies. Antepartum haemorrhage. Co-existing uterine fibroids. Macrosomic baby- birth weight ≥4kg. Intrauterine fetal death. Preeclampsia. Others are history of thromboembolic disease, medical conditions such as major liver, heart, kidney, brain and bleeding disorders, anticoagulant therapy, patients requiring blood transfusion due to anaemia and polyhydramnios. The medical conditions will be excluded from thorough history and examination of the patient and those with a positive history and examination findings suggestive of these medical conditions will be excluded from the study. Adult: 19 Year-44 Year 20 Year(s) 40 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 13/02/2020 UPTH ETHICS COMMITTE
Ethics Committee Address
Street address City Postal code Country
CHOBA PORT HARCOURT PMB6173 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of blood loss during and after caesarean section. During and two hours after caesarean section
Secondary Outcome Additional uterotonic drugs. During and two hours after caesarean section
Secondary Outcome 2. Blood transfusion. During and 48 hours after caesarean section
Secondary Outcome 3. Surgical interventions. During and after caesarean section
Secondary Outcome Maternal and fetal side effects. During and two hours after caesarean section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIVERSITY OF PORT HARCOURT TEACHING HOSPITAL CHOBA PORT HARCOURT PMB 6173 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
JEMIRIGBE OMAWUMI DARLINTON Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital PORT HARCOURT PMB6173 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor JEMIRIGBE OMAWUMI DARLINGTON Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital PORT HARCOURT PMB6173 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Orazulike Ngozi Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital PORT HARCOURT PMB6173 Nigeria
Prof. Ogu Rosemary Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital PORT HARCOURT PMB6173 Nigeria
Dr. Oranu Emmanuel Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital PORT HARCOURT PMB6173 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omawumi Jemirigbe owumi2012@yahoo.com 08034059131 Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital
City Postal code Country Position/Affiliation
Port Harcourt PMB6173 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Omawumi Jemirigbe owumi2012@yahoo.com 08034059131 Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital
City Postal code Country Position/Affiliation
Port Harcourt PMB6173 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Ngozi Orazulike ngorazulike@yahoo.com 08033048050 Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital
City Postal code Country Position/Affiliation
Port Harcourt PMB6173 Nigeria Head of Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participants data that underlie the results reported would be shared after de-identification. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 11 months after study completion only those who need it for academic and research purposes would be allowed access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 04/02/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 04/02/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information