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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202507860138080 Date of Registration: 08/07/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of the effects of combined oxytocin/tranexamic acid versus oxytocin alone in reducing blood loss in vaginal delivery
Official scientific title Comparison of the effects of combined oxytocin/tranexamic acid versus oxytocin alone in reducing blood loss in vaginal delivery at Maitama district hospital, a randomised control trial
Brief summary describing the background and objectives of the trial Postpartum haemorrhage (PPH) is one of the major causes of maternal morbidity and mortality worldwide, especially in low-and middle- resource income countries. The World Health Organization (WHO) recommends the use of uterotonic agents such as oxytocin for the prevention of PPH due to uterine atony. Tranexamic acid (TXA), an antifibrinolytic agent, has been proposed as a potentially useful complement to uterotonic agents for prevention of PPH. The objectives include; to evaluate and compare the effect of prophylactic administration of combined tranexamic acid/oxytocin at reducing blood loss during vaginal delivery in Maitama District Hospital, Abuja. To determine and compare the incidence of primary PPH, need for additional uterotonics, blood transfusion and occurrence of maternal side effects and need for surgical intervention among parturients receiving prophylactic combined tranexamic acid/oxytocin and those receiving oxytocin alone for reducing blood loss during vaginal delivery in MDH Abuja.
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 Reducing blood loss following vaginal delivery
Purpose of the trial Education /Training
Anticipated trial start date 01/08/2024
Actual trial start date 01/11/2024
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date 31/03/2025
Anticipated target sample size (number of participants) 154
Actual target sample size (number of participants) 154
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
FHREC202401125310524 FCT HEALTH RESEARCH ETHICS COMMITTEE
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tranexamic acid group will receive 10 IU of oxytocin bolus plus 1g (10mls) of TXA intravenously, both as single doses Tranexamic acid group: 10 IU of oxytocin STAT dose plus 1g (10mls) of TXA single dose 10 IU of oxytocin bolus plus 1g (10mls) of TXA intravenously immediately after vaginal delivery as part of the active management of the third stage of labour 77
Control Group placebo group Will receive 10 IU oxytocin bolus with 10mls of water for injection as placebo(both as single/STAT doses) Single/STAT doses Will receive 10 IU oxytocin bolus with 10mls of water for injection as placebo(both as single/STAT doses) immediately after vaginal delivery as part of the active management of the third stage of labour 77 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women with singleton pregnancy at term Presenting in spontaneous labour no contraindication to vaginal delivery women who have consented to the study Hypersensitivity to oxytocin or tranexamic acid women with known history of thrombotic events (including thrombophilia and coagulopathy), cardiac diseases, renal or liver diseases, epilepsy Any contraindications to vaginal delivery Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 16 Year(s) 39 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 31/05/2024 FEDERAL CAPITAL TERRITORY HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
1 KAPITAL STREET, AREA 11, GARKI, ABUJA ABUJA 900103 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate and compare the effect of prophylactic administration of combined tranexamic acid/oxytocin at reducing blood loss during vaginal delivery and to evaluate the effect of prophylactic administration of oxytocin alone at reducing blood loss during vaginal delivery in Maitama District Hospital, Abuja.istrict Hospital, Abuja. 1 and 2 hours after delivery
Secondary Outcome To determine and compare the incidence of primary PPH, need for additional uterotonics, blood transfusion and occurrence of maternal side effects and need for surgical intervention among parturients receiving prophylactic combined tranexamic acid/oxytocin and those receiving oxytocin alone for reducing blood loss during vaginal delivery in MDH Abuja. 1 and 2 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MAITAMA DISTRICT HOSPITAL ABUJA 61 AGUIYI IRONSI STREET, MAITAMA ABUJA Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
NAFISA MUHAMMAD IBRAHIM 3 OTUKPO STREET, AREA 11, GARKI, ABUJA ABUJA Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NAFISA MUHAMMAD IBRAHIM 3 OTUKPO STREET, AREA 11, GARKI, ABUJA ABUJA Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator NAFISA MUHAMMAD IBRAHIM nafitsofo@gmail.com +2348068912347 3 OTUKPO STREET, AREA 11, GARKI
City Postal code Country Position/Affiliation
ABUJA Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries JAMEELA KHADEEJA SODANGI amrahsodangi@yahoo.com +2347084061537 61 Aguiyi Ironsi street
City Postal code Country Position/Affiliation
ABUJA Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries YIBALA AKPAMA EDIMEK yibiakpama@yahoo.com +2348063922919 15 CONAKRY STREET, WUSE
City Postal code Country Position/Affiliation
ABUJA Nigeria CONSULTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the study will be made available after deidentification of all the participants, as only their card numbers will be used. Other documents, including study protocol, statistical analysis plan, informed consent form, study report with analytic code will also be made available. Data from the study will be made available indefinitely to anyone who wishes to access it, immediately following publication. No end date. Informed Consent Form NO END DATE Access criteria will be open with an access control, security and compliance. Criteria will be based on quality of the request
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 04/07/2025 response to comments COMPARISON OF THE EFFECTS OF COMBINED OXYTOCIN/TRANEXAMIC ACID VERSUS OXYTOCIN ALONE IN REDUCING BLOOD LOSS IN VAGINAL DELIVERY Comparison of the effects of combined oxytocin/tranexamic acid versus oxytocin alone in reducing blood loss in vaginal delivery
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 04/07/2025 response to comments COMPARISON OF THE EFFECTS OF COMBINED OXYTOCIN/TRANEXAMIC ACID VERSUS OXYTOCIN ALONE IN REDUCING BLOOD LOSS IN VAGINAL DELIVERY AT MAITAMA DISTRICT HOSPITAL, A RCT Comparison of the effects of combined oxytocin/tranexamic acid versus oxytocin alone in reducing blood loss in vaginal delivery at Maitama district hospital, a randomised control trial
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 04/07/2025 response to comments Women with singleton pregnancy at term, Presenting in spontaneous labour, no contraindication to vaginal delivery, Women who have consented to the study. Women with singleton pregnancy at term Presenting in spontaneous labour no contraindication to vaginal delivery women who have consented to the study
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 04/07/2025 response to comments Hypersensitivity to oxytocin or tranexamic acid women with known history of thrombotic events (including thrombophilia and coagulopathy), cardiac diseases, renal or liver diseases, epilepsy Any contraindications to vaginal delivery. Hypersensitivity to oxytocin or tranexamic acid women with known history of thrombotic events (including thrombophilia and coagulopathy), cardiac diseases, renal or liver diseases, epilepsy Any contraindications to vaginal delivery
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 08/07/2025 PACTR Admin Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year