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.: PACTR202201838645377 Date of Registration: 05/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title OXYTOCIN VERSUS OXYTOCIN AND MELATONIN IN THE REDUCTION OF BLOOD LOSS AT CAESAREAN SECTION AT THE ALEX EKWUEME FEDERAL UNIVERSITY HOSPITAL, ABAKALIKI
Official scientific title OXYTOCIN VERSUS OXYTOCIN AND MELATONIN IN THE REDUCTION OF BLOOD LOSS AT CAESAREAN SECTION AT THE ALEX EKWUEME FEDERAL UNIVERSITY HOSPITAL, ABAKALIKI
Brief summary describing the background and objectives of the trial Primary postpartum hemorrhage is a major cause of maternal mortality in resource poor settings resulting mainly from uterine atony. Oxytocin is one of the main oxytocics used in preventing PPH. In redource poor settings, its potency may be affected by poor storage facility and incessant power outages. In some cases involving high risk patients, it may not be able to stand on its own. It is important to have altetnative adjunctive agents with less side effects. Objectives: To compare blood loss at caesarean section after administration of oxytocin versus oxytocin and melatonin To compare the side effects after administration of oxytocin versus oxytocin and melatonin.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 08/11/2021
Actual trial start date
Anticipated date of last follow up 07/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 254
Actual target sample size (number of participants)
Recruitment status Active, not 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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Oxytocin group 10 I.U stat Once dosing 10 I.U oxytocin will be given intravenously within 1 minute of delivery of the baby while 100mg of Vitamin C will be placed sublingually immediately after administration of spinal Anaesthesia 127 Placebo
Experimental Group Melatonin group 10mg sublingually Once dosing 10 mg melatonin will be given sublingually immediately after administration of spinal Anaesthesia. 10 I.U oxytocin will then be administered intravenously within 1 minute of delivery of the baby 127
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women with term pregnancy 1. Patients with documented bleeding disorders,. 2. Acute obstetric emergency 3.Medical diseases in pregnancy such as cardiac disease, or haemoglobinopathies 4. Antepartum haemorrhage 5. Previous uterine rupture. 6.Any contraindication to spinal anaesthesia Adult: 19 Year-44 Year 15 Year(s) 49 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 18/08/2021 Alex Ekwueme Federal University Teaching Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital, Abakaliki Abakaliki PMB 102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome *4.13.1 Outcome measures* The primary outcome measures will be change in haemoglobin levels of the mother after surgery and the estimated blood loss after the caesarean section. Estimation of blood loss will be made immediately after Caesarean section. Hemoglobin will be checked 24 hours before and 48 hours after Caesarean section
Secondary Outcome The secondary outcome measures include development of primary postpartum haemorrhage, need for rescue drugs, blood transfusion. PPH- within 24 hours of surgery, need for rescue drug within 24 hours of surgery, blood transfusion within 24 hours of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital Hospital road Abakaliki PMB 102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Nwaedu Uchenna Department of OBGYN Alex Ekwueme Federal University Teaching Hospital Abakaliki PMB 102 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Nwaedu Uchenna Aguogboriga Abakaliki PMB 102 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Uchenna Nwaedu uchesonedum@gmail.com +2348038691048 Department of OBGYN, Alex Ekwueme Federal University Teaching Hospital
City Postal code Country Position/Affiliation
Abakaliki PMB 102 Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Arinze Ikeotuonye arimze790@gmail.com +2348038730293 Department of OBGYN, Alex Ekwueme Federal University Teaching Hospital
City Postal code Country Position/Affiliation
Abakaliki PMB 102 Nigeria Doctor
Role Name Email Phone Street address
Scientific Enquiries Odidika Umeora oujair@yahoo.com +2348039558074 Department of OBGYN, Alex Ekwueme Federal University Teaching Hospital
City Postal code Country Position/Affiliation
Abakaliki PMB 102 Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data collected during the trial and after deidentification will be shared. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be made available immediately following publication with no end date Access to data can be granted anyone who wishes to access it and the analyses for any purpose. Data will be available indefinitely at a link to be provided subsequently.
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