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.: PACTR202404628293844 Date of Approval: 10/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Early Intravenous oxytocin infusion versus late oxytocin bolus plus infusion on blood loss during caesarean section
Official scientific title Effect of Pre-uterine incision oxytocin infusion versus oxytocin bolus along oxytocin infusion after foetal delivery on blood loss during Caesarean Sections at UITH: a randomized controlled trial.
Brief summary describing the background and objectives of the trial There are varied guidelines for using oxytocin but there is no consensus on the best timing for prophylactic oxytocin administration during caesarean section to prevent postpartum hemorrhage. Concerns have been raised regarding the cardiovascular effects of bolus oxytocin contributing to maternal mortality; thus, there is a need to study the efficacy of oxytocin infusion-only regimens. The study aims to compare the effect of pre-uterine incision intravenous oxytocin infusion with oxytocin bolus along with oxytocin infusion after foetal delivery on blood loss during caesarean section. The specific objectives include comparing the total blood loss at surgery, mean reduction in haematocrit, need for additional uterotonics, need for blood transfusion and APGAR scores of babies in the two groups.
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 at Caesarean Section
Purpose of the trial Education /Training
Anticipated trial start date 01/03/2024
Actual trial start date 01/03/2024
Anticipated date of last follow up 31/08/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 144
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 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 Group A Early Group 30 IU of oxytocin in 500ml of Normal saline 4 Hours 30 IU of oxytocin in 500ml of Normal saline at 33 drops per minute just before making an incision on the uterus 72
Control Group Group B Late Group 10IU of oxytocin bolus and 20 IU of oxytocin in 500ml of normal saline 4 hours 10IU of oxytocin bolus and 20 IU of oxytocin in 500ml of normal saline after delivery of the foetus 72 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting Pregnant women with singleton foetus undergoing caesarean section at ≥37 weeks gestational age placenta previa Abruptio Placenta Women with known renal disorders, women with coagulopathy current or previous history of heart disease Adult: 19 Year-44 Year 18 Year(s) 45 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 11/12/2023 UITH Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Ilorin Teaching Hospital Ilorin 1459 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total blood loss at surgery In the operating theatre after completion of the caesarean section
Secondary Outcome The mean difference in pre-operative and 24-hour postoperative haematocrit levels Before the Caesarean Section and 24 Hours Post Operatively
Secondary Outcome Incidence of intraoperative blood loss of ≥1000 ml At the completion of the Caesarean section in the operating theatre
Secondary Outcome Need for blood transfusion During surgery and within 24 hours after the surgery
Secondary Outcome Need for additional uterotonics or antihemorrhagic agents During the Caesarean Section
Secondary Outcome Apgar scores of the foetus in the first and fifth minutes one minute after delivery of the foetus and 5 minutes after delivery of the foetus
Secondary Outcome Mean blood loss in the pre-uterine incision group in women with pre-labour CS and those who were not in labour At the completion of Caesarean Section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital University of Ilorin Teaching Hospital Oke-Ose Ilorin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Shiru Mariam Motunrayo House J5 HRA Ilorin Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shiru Mariam Motunrayo House J5 HRA Ilorin Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Professor M A Ijaiya Department of Obstetrics and Gynaecology University of Ilorin Teaching Hospital Ilorin Nigeria
Professor L O Omokanye Department of Obstetrics and Gynaecology University of Ilorin Teaching Hospital Ilorin Nigeria
Professor O R Balogun Department of Obstetrics and Gynaecology University of Ilorin Teaching Hospital Ilorin Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mariam Shiru yinusamaro@gmail.com +2348065454593 Department of Obstetrics and Gynaecology University of Ilorin Teaching Hospital
City Postal code Country Position/Affiliation
Ilorin Nigeria Senior Registra University of Ilorin Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Mariam Shiru yinusamaro@gmail.com +2348065454593 House J5 HRA
City Postal code Country Position/Affiliation
Ilorin Nigeria Researcher University of Ilorin Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Munirudeen Ijaiya munirijaiya@yahoo.com +2348033801565 Department of Obstetrics and Gynaecology University of Ilorin Teaching Hospital
City Postal code Country Position/Affiliation
Ilorin Nigeria Consultant University of Ilorin Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participant data that underlie the results reported in the trial after deidentification will be shared Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Open
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