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.: PACTR202111830813291 Date of Approval: 10/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Initiating Intravenous Oxytocin Infusion before Uterine Incision on Blood Loss During Elective Caesarean Section: A Randomized Clinical Trial
Official scientific title Presurgery oxytocin trial
Brief summary describing the background and objectives of the trial Postpartum hemorrhage is a significant cause of maternal morbidity and mortality worldwide. Uterine atony is the commonest cause of postpartum hemorrhage and is a common complication of caesarean section. AIM: To compare the effect of initiating intravenous oxytocin infusion before uterine incision versus after umbilical cord clamping on blood loss during elective caesarean section.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) POT
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Post partum haemorrhage prevention
Purpose of the trial Prevention
Anticipated trial start date 02/09/2019
Actual trial start date 09/09/2019
Anticipated date of last follow up 28/02/2020
Actual Last follow-up date 10/03/2020
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 116
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group B 40 units of oxytocin in 1 litre of normal saline given at 40 drops per minute 4 hours post operation Participants were started on 40 units of oxytocin in 1 litre of normal saline after umbilical cord clamping. The infusion was delivered at 20 drops per minute and continued until 4 hours post operation. 58 Active-Treatment of Control Group
Experimental Group Group A 40 units of oxytocin in 1Litre of normal saline at 20 drops per minute 4 hours post operation Participants were started on 40 units of oxytocin in 1 litre of normal saline just before making uterine incision,The infusion was delivered at 20 drops per minute and continued until 4 hours post operation. 58
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Singleton pregnancy • Term pregnancy (37 - 42 weeks gestational age) • Booked for elective caesarean section, • Willingness to participate in the study, were included. • Women with multiple gestation • Women with polyhydramnios or macrosomia • Parturients with antepartum haemorrhage • Parturients with heart or renal disease • Women with 2 or more previous CS • Women with bleeding disorders • Women with previous history of postpartum haemorrhage • Women who did not consent to the study Adult: 19 Year-44 Year 18 Year(s) 48 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 13/06/2019 Research and Ethics Committee AEFUTHA
Ethics Committee Address
Street address City Postal code Country
No 1 AEFUTHA road Abakaliki 48001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • The mean blood loss during elective caesarean section in the two arms Estimated blood loss in immediate post operative and Packed Cell volume post operatively
Secondary Outcome . The need for additional uterotonics to control bleeding • The need for blood transfusion or additional surgical intervention • Maternal side effects(nausea and vomiting, chest pain, palpitation, maternal death) • Neonatal outcomes of the study groups during the surgery and immediate post operative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme University Teaching Hospital Abakaliki No 1 AEFUTHA road, Abakaliki 48001 Nigeria
Mile 4 Hospital Mile 4 Old Enugu-Abakaliki Expressway Abakaliki 48001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self No 1 AEFUTHA road Abakaliki 48001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Egede John Okafor Plot 108 Nkaliki GRA Abakaliki 48001 Nigeria Individual
Primary Sponsor Nwigboji Ndukwe Wilson No1 AEFUTHA road Abakaliki 48001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nwigboji Ndukwe Wilson willindu4life@gmail.com +2348067576774 No 1 AEFUTHA road
City Postal code Country Position/Affiliation
Abakaliki 48001 Nigeria consultant
Role Name Email Phone Street address
Scientific Enquiries Egede John Okafor egedejohno@gmail.com +2348037797950 Plot 108 Nkaliki GRA
City Postal code Country Position/Affiliation
Abakaliki 49001 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Egede John Okafor egedejohno@gmail.com +2348037797950 Plot 108 Nkaliki GRA
City Postal code Country Position/Affiliation
Abakaliki 48001 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants data will be available(including data deidentification). All participants data collected during trial (after deidentification) will be shared. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediate following publication, no end date. Any individual who wishes to access the data For what type of analysis: any purpose provided it is for scientific purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
wedonenothavewebsite.com Yes 05/11/2021 05/11/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 05/11/2021 Result - 05/11/2021 Result - 05/11/2021 Result - 05/11/2021 Result - 05/11/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information