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.: PACTR202211491969865 Date of Approval: 28/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study of the effects of early and delayed cord clamping on haematocrit and serum bilirubin among term neonates at Benue State University Teaching Hospital, Makurdi
Official scientific title Comparative study of the effects of early and delayed cord clamping on haematocrit and serum bilirubin among term neonates at Benue State University Teaching Hospital, Makurdi
Brief summary describing the background and objectives of the trial Background: The optimal timing to clamp the umbilical cord has been the subject of much debate and is unclear. It varies from early cord clamping (ECC) generally done immediately after birth, and delayed cord clamping (DCC) which usually involves clamping the umbilical cord greater than 30 seconds after the birth or when cord pulsation has ceased. Aim: This study was aimed to compare the effects of early versus delayed umbilical cord clamping after a normal delivery on neonatal haematocrit and serum bilirubin.
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 Delayed clamping of the umbilical cord after delivery of the baby.
Anticipated trial start date 01/08/2021
Actual trial start date 01/10/2021
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 30/09/2022
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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
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 Delayed cord clamping Cord clamping delayed for 3 minutes Cord clamping delayed for 3 minutes The time of birth was noted by the midwife assistant monitoring time of cord clamping with the stopwatch. All babies immediately after birth will be placed on the same level with the maternal bed while simultaneously basic newborn care was be done for the intervention group and cord clamping was delayed for 3 minutes. 100
Control Group Early cord clamping Cord clamping within 30 seconds of delivery of the baby Cord clamping within 30 seconds of delivery of the baby The time of birth was noted by the midwife assistant monitoring time of cord clamping with the stopwatch. Immediate cord clamping (within 30 seconds of delivery of the baby) and cutting was done and the baby given basic newborn care. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This included consenting term pregnant women without any high-risk factor with foetus in cephalic presentation undergoing vaginal delivery. All pregnant women who declined consent multiple gestations Rhesus incompatibility antepartum haemorrhage anaemia diabetes mellitus retroviral disease hypertension heart disease or any medical illness. Women who were not stable, required urgent resuscitation. Neonates who had congenital malformations foetal distress respiratory distress syndrome meconium aspiration syndrome (MAS) neonatal sepsis persistent pulmonary hypertension (PPHTN) intrauterine growth restriction Large for Gestational Age Small for Gestational Age New born: 0 Day-1 Month 0 Day(s) 1 Day(s) Both
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 18/01/2021 Health Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Kilometer 3, Gboko Road, Makurdi Makurdi 102131 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome neonatal haematocrit value 2 hours after birth
Secondary Outcome neonatal haematocrit at 24 hours of age
Secondary Outcome neonatal serum bilirubin level 24 hours of age
Secondary Outcome maternal postpartum blood loss within 24 hours postpartum
Secondary Outcome adverse neonatal outcomes such as anaemia, polycythaemia and jaundice. within 24 hours postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benue State University Teaching Hospital Makurdi Nigeria Kilometer 3, Gboko Road Makurdi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ushakuma Michael Anenga Kilometer 3, Gboko Road Makurdi Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Ushakuma Michael Anenga Kilometer 3, Gboko Road Makurdi Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ushakuma Anenga uanenga@yahoo.com +2347031616767 Kilometer 3, Gboko Road
City Postal code Country Position/Affiliation
Makurdi Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Terrumun Swende swendetz@yahoo.com +2348065720059 Kilometer 3, Gboko Road
City Postal code Country Position/Affiliation
Makurdi Nigeria Supervisor
Role Name Email Phone Street address
Public Enquiries Bernard Utoo utoobt86@gmail.com +2348033725168 Kilometer 3, Gboko Road
City Postal code Country Position/Affiliation
Makurdi Nigeria Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in this study. Data or samples shared will be coded, with no PHI included. Informed Consent Form,Statistical Analysis Plan Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact uanenga@yahoo.com
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