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.: PACTR202203635007430 Date of Approval: 24/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title COMPARISON OF THE CLINICAL EFFICACY OF COLD-CHAIN AND OUTSIDE COLD-CHAIN OXYTOCIN IN DECREASING POSTPARTUM BLOOD LOSS IN WARRI, DELTA STATE, NIGERIA.
Official scientific title A DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECT OF ROOM-TEMPERATURE STORAGE ON THE CLINICAL EFFICACY OF OXYTOCIN IN DECREASING BLOOD LOSS AFTER VAGINAL DELIVERY IN WARRI, DELTA STATE, NIGERIA.
Brief summary describing the background and objectives of the trial BACKGROUND: Postpartum haemorrhage is the most common cause of maternal mortality globally. Oxytocin, the recommended drug for the prevention of postpartum haemorrhage, is heat-labile, and therefore requires compliance with a standard cold-chain system of storage. Evidence is lacking on the clinical implication of this degradation in preventing postpartum haemorrhage. AIMS AND OBJECTIVES: The study aims to compare the effect of storage at room temperature on the clinical efficacy of oxytocin in decreasing blood loss after vaginal delivery. The objectives of the study are to compare the amount of postpartum blood loss, PPH >1000mls, the need for additional uterotonic, the need for blood transfusion, and the occurrence of nausea and vomiting between women that receive oxytocin stored at room temperature and those that receive oxytocin stored in the cold-chain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2021
Actual trial start date 01/04/2021
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 140
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 Permuted block randomization 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
Control Group COLD ARM 10 IU of cold-chain oxytocin intravenous bolus 10 IU of oxytocin stored in the cold chain is given intravenously after delivery of the baby. 70 Active-Treatment of Control Group
Experimental Group WARM ARM 10 IU of oxytocin stored at room temperature. intravenous bolus 10 IU of oxytocin stored at room temperature is administered after delivery of the baby. 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Provide consent Term pregnancy Live fetus Singleton pregnancy Cephalic presenting fetus Parity less than 5 History of atonic postpartum haemorrhage Uterine fibroids Grand multiparity Previous caesarean section Multiple gestations Placenta praevia Use of anticoagulants or tocolytics Chorioamnionitis Any known uterine malformation History of coagulopathy. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 44 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 01/08/2019 Central Hospital Warri Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
No.1 Mabiaku road, Off Warri-Sapele road, GRA Warri PMB 1004 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of postpartum blood loss 1 hour after delivery of the placenta
Secondary Outcome PPH greater than 500mls 1 hour after delivery of the placenta
Secondary Outcome PPH greater than 1000mls 1 hour after delivery of the placenta
Secondary Outcome Use of additional uterotonic 1 hour after delivery of the placenta
Secondary Outcome Need for blood transfusion 1 hour after delivery of the placenta
Secondary Outcome Adverse effects 1 hour after delivery of the placenta
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Central Hospital Warri No.1 Mabiaku road, Off Warri-Sapele road, GRA Warri Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
OKWUCHUKWU ONYEOWUZONI No.1 Mabiaku road, Off Warri-Sapele road, GRA Warri Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OKWUCHUKWU ONYEOWUZONI No.1 Mabiaku road, Off Warri-Sapele road, GRA Warri Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
PAUL OKUBOR NO.1 MABIAKU ROAD, OFF WARRI-SAPELE ROAD, GRA Warri Nigeria
CHUKWUDEME DARLINGTON ODIONWUNAKA NO.1 MABIAKU ROAD, OFF WARRI-SAPELE ROAD, GRA Warri Nigeria
CHRISTOPHER O. AIMAKHU UNIVERSITY COLLEGE HOSPITAL, QUEEN ELIZABETH ROAD IBADAN Nigeria
OKWUCHUKWU ONYEOWUZONI NO.1 MABIAKU ROAD, OFF WARRI-SAPELE ROAD, GRA Warri Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OKWUCHUKWU ONYEOWUZONI OKWUWUZONI@GMAIL.COM +2347039739700 No.1 Mabiaku road, Off Warri-Sapele road, GRA
City Postal code Country Position/Affiliation
Warri Nigeria OBGYN Senior Registrar
Role Name Email Phone Street address
Public Enquiries OKWUCHUKWU ONYEOWUZONI OKWUWUZONI@GMAIL.COM +2347039739700 No.1 Mabiaku road, Off Warri-Sapele road, GRA
City Postal code Country Position/Affiliation
Warri Nigeria OBGYN Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries OKWUCHUKWU ONYEOWUZONI OKWUWUZONI@GMAIL.COM +2347039739700 No.1 Mabiaku road, Off Warri-Sapele road, GRA
City Postal code Country Position/Affiliation
Warri Nigeria OBGYN Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data summary results. All of the individual participant data collected during the trial, after deidentification. Informed Consent Form,Study Protocol 1 year Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 15/03/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 15/03/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information