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.: PACTR201909775190644 Date of Approval: 18/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized controlled trial of two methods of oxytocin infusion administration in prevention of blood loss at caesarean section
Official scientific title A randomized controlled trial of early versus late administration of oxytocin infusion in prevention of blood loss at caesarean section
Brief summary describing the background and objectives of the trial Introduction Caesarean section has remained one of the most commonly performed procedures and there has been a rising trend in its rate globally [1]. Postpartum hemorrhage (PPH) is one of the leading causes of maternal mortality and morbidity worldwide and accounts for nearly a quarter of all maternal deaths and maternal mortality due to PPH is most prevalent in the first 24 hours postpartum [2, 3]. Uterine atony is the leading cause of postpartum bleeding and is responsible for about 80% of these cases [3, 4]. Use of uterotonic agents has been demonstrated to be effective in the prevention and reduction of PPH [5, 6]. Oxytocin is the most commonly used uterotonic agent in obstetrics because of its low cost and rapid onset of action. It is routinely administered after both normal and operative delivery to initiate and maintain adequate uterine contractility for minimizing blood loss and preventing postpartum hemorrhage [7]. In the United Kingdom (UK), the guidelines of the Royal College of Obstetricians and Gynaecologists (UK) on caesarean section recommend a slow intravenous bolus dose of 5 IU of oxytocin after delivery of the infant [8] and a survey of obstetricians and anesthetists in the UK revealed that the use of an oxytocin bolus was standard treatment, although the dose varied between 5 IU and 10 IU [9]. However, in the United States, the use of an oxytocin infusion instead of a bolus dose is recommended. This approach may reflect concerns about the physiological effects of oxytocin bolus [10]. Since intravenous oxytocin has a short half-life (4-10 minutes); the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and in the immediate postpartum period [11]. There have been several studies done to evaluate different regimens, routes and mode of administration of oxytocin in the prevention of postpartum haemorrhage [5, 7, 11, 12]. These studies sought to determine doses th
Type of trial RCT
Acronym (If the trial has an acronym then please provide) oxytocin infusion and blood loss
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/02/2019
Actual trial start date 04/03/2019
Anticipated date of last follow up 03/08/2019
Actual Last follow-up date 03/09/2019
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 230
Recruitment status Completed
Publication URL Not applicable
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group One 30IU Oxytocin in 500 ml of 0.9% normal saline commenced just before incision on the uterus and infused at 125ml/hr Four hours Group (I): women received an IV infusion of oxytocin (SyntocinonVR ; Novartis Pharma, Berne, Switzerland) 30 IU dissolves into 500 mL of normal 0.9% sodium chloride solution and infused at a rate of 125 mL/hour. Infusion started immediately after opening the visceral peritoneum and just before incising the lower uterine segment during CS 115
Control Group Group Two 30 IU oxytocin (SyntocinonVR ; Novartis Pharma, Berne, Switzerland) dissolves into 500 mL of normal 0.9% sodium chloride solution and infused at a rate of 125 mL/hour after clamping of the umbilical cord Four hours Women received 30 IU oxytocin (SyntocinonVR ; Novartis Pharma, Berne, Switzerland) dissolves into 500 mL of normal 0.9% sodium chloride solution and infused at a rate of 125 mL/hour and the rate of infusion started immediately after clamping the umbilical cord. The IV route was filled with oxytocin/saline solution prior to start the infusion. 115 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
pregnant women with a single fetus at term >37 weeks of gestational age, with American Society of Anesthesiology (ASA) physical status I or II Women at high risk for uterine atony such as anemia (Hb <8 g/dL), multiple gestation, polyhydramnios placenta previa, fetal macrosomia two or more previous CS preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopathy 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 04/02/2019 Ethics and Research Committee Ekiti State University Teaching Hospital Ado Ekiti
Ethics Committee Address
Street address City Postal code Country
Adebayo Street, Ado Ekiti Ado Ekiti 370001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood loss during caesarean section Immediately after surgery
Secondary Outcome Post-operative blood loss, Difference in pre- and post-operative packed cell volume/ haemoglobin concentration need for additional uterotonics need for blood transfusion need for additional surgical procedures 24 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ekiti State University Teaching Hospital Adebayo Street, Iworoko Road Ado Ekiti 370001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aduloju Olusola Peter Adebayo Street Ado Ekiti 370001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Peter Aduloju peter.aduloju@yahoo.com 23408033900908 Ekiti State University Teaching Hospital
City Postal code Country Position/Affiliation
Ado Ekiti Nigeria Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Akinyemi Akintayo akinyemiakintayo@yahoo.co.uk +2348033767542 Adebayo Street
City Postal code Country Position/Affiliation
Ado Ekiti 370001 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Oluwadare Ipinnimo stildrdare@yahoo.com +2348033748593 Adebayo Street
City Postal code Country Position/Affiliation
Ado Ekiti 370001 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during trial, after de-identification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 4 years access to data: controlled type of data analysis permitted: any purpose process of requests; e mail decision: authors criteria for reviewing request: quality of 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