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.: PACTR202206735622089 Date of Approval: 21/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTS OF EARLY VERSUS LATE UMBILICAL CORD CLAMPING ON HAEMOGLOBIN LEVELS OF NEONATES DELIVERED IN A NIGERIAN TERTIARY HOSPITAL: A RANDOMISED CONTROLLED TRIAL
Official scientific title EFFECTS OF EARLY VERSUS LATE UMBILICAL CORD CLAMPING ON HAEMOGLOBIN LEVELS OF NEONATES DELIVERED IN A NIGERIAN TERTIARY HOSPITAL: A RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Determining the appropriate timing for umbilical cord clamping after delivery of the new born baby has been a controversial issue. There is a wide variation in the definitions of early and delayed cord clamping in terms of timing of the clamping. Early cord clamping is often defined as the clamping of the umbilical cord between delivery and 30 - 60 seconds after delivery, whereas delayed cord clampingis the clamping of the cord beyond one minute of delivery. Although there has been: some: randomised controlled: trials comparing: the benefits of: delayed versus early cord: clamping, yet an ideal time has not been mapped out. Previously, early cord clamping was incorporated as an important component of active management of third stage of labour, when it was thought to prevent primary post-partum haemorrhage. However, recent studies have revealed that it is of no significant benefit in the prevention of postpartum haemorrhage. Objective To investigate and compare the effects of early and delayed cord clamping on thehaemoglobin levels of neonates delivered in Enugu State University of Science & TechnologyTeaching Hospital, Parklane, South East of Nigeria
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Labour/Delivery and Postpartum
Purpose of the trial Early versus Delayed Cord clamping during 3rd stage of labour
Anticipated trial start date 13/06/2022
Actual trial start date 22/06/2022
Anticipated date of last follow up 13/12/2022
Actual Last follow-up date 22/12/2022
Anticipated target sample size (number of participants) 270
Actual target sample size (number of participants)
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 Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Early Cord clamping group Not applicable. The Umbilical cord was clamped within 30 seconds of delivery of baby 30 seconds Following delivery, the neonate will be kept at 15 centimetres below the maternal vulva; then the participant in this group will undergoes early cord clamping (which involved double clamping of the umbilical cord within 30seconds of delivery of the neonate) following which Umblical cord blood sample (1.5mls) will then be collected from a point between the clamps into an EDTA tube (Sample A) and sent to the haematology laboratory for Haemoglobin analysis with the Auto analyser Sysmex XE2100 (Sysmex, Kobe, Japan). After the sample collection, the cord will cut with a cord scissors and delivered via controlled cord traction. The baby will now be handed over to neonatologist for examination. Routine postpartum care will be given to the mother. The neonatal venous blood sample will also be taken 48 post partum for haemoglobin analysis. 135
Control Group Delayed Cord Clamping group Dose not applicable. The participants in this group will undergo delayed Cord clamping after two minutes of delivery 2 minutes Following delivery, the neonate will be kept at 15 centimetres below the maternal vulva; then the participants who picked Delayed Cord Clamping underwent delayed cord clamping (which involved double clamping of the umbilical cord after 2 minutes of delivery of the neonate). The attending neonatologist will examine the newborn to rule out congenital anomalies. Umblical cord blood sample (1.5 mls) will be collected from a point between the clamps into an EDTA tube (Sample A) and sent to the haematology laboratory for analysis with the Auto analyser Sysmex XE2100 (Sysmex, Kobe, Japan). After the sample collection, the cord will be cut with a cord scissors. Controlled cord traction will be done and the routine postpartum care will be given to the mother. The neonate will subsequently be handed over to the mother for breastfeeding, after cleaning up and providing warm covering. Then 48hours after the delivery of the neonate, venous blood sample (1.5mls, Sample B) will be collected from baby’s vein into an EDTA tube after gently applying a tourniquet. Topical anaesthetic cream will be applied on the puncture site. The sample will be sent to the haematology laboratory for analysis. 135 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting participants. Term healthy pregnant women. All healthy neonates without any complication delivered via spontaneous vaginal approach will be included in the study. Exclusion criteria are multiple, preterm and post term pregnancies, as well as mothers who refused to give consent. Pregnancies complicated by medical conditions like diabetes mellitus, hypertension, cardiac diseases, sickle cell disease, chorioamnioties, antepartum and postpartum haemorrhage will also be excluded. Neonates with congenital diseases, babies of high risk pregnancies like pre-eclampsia, and neonates who will become sick before 48 hours will be excluded Adult: 19 Year-44 Year 18 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 10/06/2022 Ethics committee Enugu State University Teaching Hospital Park lane Enugu Nigeria
Ethics Committee Address
Street address City Postal code Country
Park lane Avenue GRA Enugu State Nigeria Enugu 400102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The mean Haemoglobin level at birth. At birth
Secondary Outcome Mean Haemoglobin level at 48 hours post partum 48 hours post partum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Enugu State University Teaching Hospital Enugu Nigeria Park lane Avenue GRA Enugu Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Perpetua Kelechi Enyinna Park lane Avenue GRA Enugu Enugu Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Perpetua Kelechi Enyinna. He is the principal investigator Park lane Avenue GRA Enugu Nigeria Enugu Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Frank O. Ezugwu Park lane Avenue GRA Enugu State Nigeria Enugu Nigeria
Dr Chukwuemeka.C. Okoro Nnewi Onitsha road Nnewi Anambra State Nigeria Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Chigozie Okafor chigolz@yahoo.com +2348034802657 Nnewi Onitsha road Nnewi Anambra State Nigeria
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Gynaecologist Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi Anambra State Nigeria
Role Name Email Phone Street address
Public Enquiries George Eleje georgel21@yahoo.com +2348068117444 Nnewi Onitsha road Nnewi Anambra State Nigeria
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Gynaecologist and Associate Professor of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
Role Name Email Phone Street address
Principal Investigator Perpetua Enyinna perpekee@gmail.com +2348035091221 Park lane Avenue GRA Enugu Nigeria
City Postal code Country Position/Affiliation
Enugu Nigeria Senior Specialist Registra Department of Obstetrics and Gynaecology Enugu State University Teaching Hospital Park lane Enugu State Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Study Protocol Immediately following publication, No end date. Not applicable
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