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.: PACTR202404740335143 Date of Approval: 23/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of delayed versus early cord clamping on maternal blood loss in elective Caesarean section at term in Enugu: A randomised controlled trial
Official scientific title Effect of delayed versus early cord clamping on maternal blood loss in elective Caesarean section at term in Enugu: A randomised controlled trial
Brief summary describing the background and objectives of the trial Umbilical cord clamping is an important process during childbirth- usually one of the components of active management of third stage of labour. Although, the optimal timing of cord clamping still remains unclear. The World Health Organisation recommends that the cord should not be clamped earlier than necessary, with many research findings revealing the benefits of delayed clamping in infants even up to their childhood. However, not much have been said regarding maternal safety from delayed cord clamping. Also, the few studies done on maternal safety were mainly focused on low risk vaginal deliveries with fewer studies from caesarean deliveries.This study will be aimed at comparing the effect of early versus delayed cord clamping on maternal blood loss among women undergoing elective caesarean delivery at term.
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 Treatment: Surgery
Anticipated trial start date 01/05/2024
Actual trial start date 13/05/2024
Anticipated date of last follow up 30/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 154
Actual target sample size (number of participants)
Recruitment status 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Delayed cord clamping Not applicable 60 seconds Cord clamping will done at 60 seconds after delivery of the baby during elective caesarean section. 77
Control Group Early cord clamping Not applicable 15 seconds Cord clamping at 15 seconds during elective Caesarean section 77 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Patients who gives informed consent to participate in the study  Booked patients  Elective Caesarean delivery at term  Singleton pregnancy  Patient with antepartum hemorrhage  Patients with multiple gestation  Patients with medical conditions such as HIV, Hepatitis B & C  Infants with signs of birth asphyxia ie non vigorous live birth requiring urgent resuscitation  Women with anemia or bleeding disorders Adult: 19 Year-44 Year 19 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 12/12/2023 Health Research Ethics Committee University of Nigeria Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Ituku-Ozalla Enugu 40001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome  This will comprise the volume of intra-operative blood loss 48 hours after caesarean section.
Secondary Outcome  Change in packed cell volume, post-partum haemorrhage, need for transfusion and duration of surgery  Apgar scores, birth weight, packed cell volume at 48 hours after birth, clinical jaundice and admission into newborn intensive care unit. Within 48 hours after caesarean section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Ituku-Ozalla Enugu 40001 Nigeria
ESUT Teaching Hospital Park Lane Enugu 400102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Funding by the authors UNTH Enugu 40001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Achara Ifeanyi John Department of Obstetrics and Gynaecology,UNTH Enugu 40001 Nigeria Individual
Secondary Sponsor Prof. Ajah Leonard Ogbonna Department of Obstetrics and Gynaecology,UNTH Enugu 40001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeanyi Achara anointedach@gmail.com +2348032763362 Department of Obstetrics and Gynaecology,UNTH
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Senior Resident Department of Obstetrics and Gynaecology UNTH Enugu
Role Name Email Phone Street address
Public Enquiries Euzebus Ezugwu euzebus.ezugwu@unn.edu.ng +2348037020295 Department of Obstetrics and Gynaecology, UNTH
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Consultant Obstetrician and Gynaecologist UNTH Enugu
Role Name Email Phone Street address
Scientific Enquiries Leonard Ajah leonard.ajah@unn.edu.ng +2348033920789 Department of Obstetrics and Gynaecology UNTH
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Consultant Obstetrician and Gynaecologist UNTH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: Yes Data obtained through this study may be provided to qualified researchers with academic interest in obstetrics and Gynaecology. Data or samples shared will be coded with the personal identification excluded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 2 years. Extension can 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 study protocol,Statistical Analysis Plan ,informed consent form and clinical study report. For more information or to submit a request, please contact pactradmin@mrc.ac.za.
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