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.: PACTR202404884596632 Date of Approval: 08/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Maternal and neonatal effects of different umbilical cord clamping method after delivery in Ilorin: A randomised control study.
Official scientific title Maternal and neonatal effects of different umbilical cord clamping method after delivery in Ilorin: A randomised control study.
Brief summary describing the background and objectives of the trial BACKGROUND: Anaemia remains the leading cause of morbidity and mortality among neonates, infants and children less than 5years; of which, iron deficiency anaemia is responsible for than 50%. Placental transfusion through delayed cord clamping or umbilical cord milking could improve neonatal iron store by 40-50mg/kg body weight. Delayed cord clamping is recommended for both preterm and term neonates. However, early umbilical cord clamping is what is being practiced in many hospitals in developing countries owning to understaffing of our labour wards. Umbilical cord milking could serve as an effective alternative to delayed cord clamping. However, there is paucity of studies that assess the safety and efficacy of umbilical cord milking in our environment. OBJECTIVE: To determine the maternal and neonatal effects of different umbilical cord clamping methods after delivery among term neonates. STUDY DESIGN: The study would be a two-tailed equality randomized control study. METHODS: A total of 168 mother-neonate pairs following maternal informed consent would be assigned to either early cord clamping, delayed cord clamping or umbilical cord milking with 56 participants in each group. Participants in early cord clamping group will have the umbilical cord clamped immediately after delivery, clamping will be at one minute after delivery for the delayed cord clamping group while those assigned to umbilical cord milking will have the umbilical cord milked three times after delivery before clamping. Haemoglobin concentration and serum bilirubin levels will be assessed for all neonates at 24-48hours after delivery as well as maternal haemoglobin level. The primary outcome would be the mean neonatal haemoglobin concentration at 24-48 hours and mean duration of third stage of labour while the secondary outcome measures would be the mean serum bilirubin level, estimated blood loss and need for maternal blood transfusion.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied maternal blood losss after delivery to rule out postpartum haemorrhage
Purpose of the trial elicit diffeent method of cord clamping after delivery
Anticipated trial start date 25/01/2024
Actual trial start date 25/01/2024
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 168
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Early cord clamping within 15seconds Babies in this group will have their umbilical cord clamped and cut immediately after delivery 56 Uncontrolled
Experimental Group Delayed cord clamping Clamping the cord will be delayed for one minute. one minute Babies in this group, their umbilical cord will be clamped after at one minute after delivery 56
Experimental Group Umbilical cord milking within 15seconds of delivery Babies allocated to this group will have their umbilical cord milked three times before clamping and cutting. 56
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• A pregnant woman who consented herself and her baby to participate in the study. • Intrapartum haemoglobin concentration ≥10g/dl • Spontaneous vaginal delivery • A live vigorous baby at birth. • Umbilical cord abnormalities e.g true knots, pseudoknots. • Rhesus negative women • Patient with chronic medical conditions e.g Sickle cell disease, diabetes mellitus. • Maternal infections e.g patient with hepatitis B, hepatitis C and HIV • Antenatally diagnosed congenital anomaly or apparent at birth. • Antepartum haemorrhage New born: 0 Day-1 Month 1 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 29/08/2023 UNIVERSITY OF ILORIN HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
OLD JEBBA ROAD, OKE-OSE, P.M.B 1459, ILORIN KWARA STATE, NIGERIA ILORIN 240003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be the mean neonatal haemoglobin at 24-48hours of life and duration of third stage of labour 24-48hours after intervention
Secondary Outcome Neonatal secondary outcome includes APGAR scores at first and fifth minutes of life, serum bilirubin level, need for phototherapy, development of polycythaemia and need for NICU admission. The maternal secondary outcome includes estimated blood loss, primary postpartum haemorrhage, need for blood transfusion and retained placenta. some will be determine immediately after delivery and some 24-48hours after delivery.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIVERSITY OF ILORIN TEACHING HOSPITAL Old Jebba road, Oke-Ose, P.M.B 1459, Ilorin kwara state, Nigeria kwara state 240003 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
AKERAADEGBOYEGA GANIYAT AS ABOVE KWARA 240003 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AKERAADEGBOYEGA GANIYAT AS ABOVE KWARA 24000 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator GANIYAT AKERAADEGBOYEGA ghanak622@gmail.com +2348157697396 NO 20mv dejo olaoye street off taoheed road basin Ilorin kwara state. Nigeria
City Postal code Country Position/Affiliation
KWARA Nigeria senior registrar in obstetrics and gynaecology department
Role Name Email Phone Street address
Public Enquiries GANIYAT AKERAADEGBOYEGA ghanak622@gmail.com 08157697396 NO 20mv dejo olaoye street off taoheed road basin Ilorin kwara state. Nigeria
City Postal code Country Position/Affiliation
ILORIN 240003 Nigeria senior registrar in obstetrics and gynaecology department UITH
Role Name Email Phone Street address
Scientific Enquiries GANIYAT AKERAADEGBOYEGA ghanak622@gmail.com 08157697396 NO 20mv dejo olaoye street off taoheed road basin Ilorin kwara state. Nigeria
City Postal code Country Position/Affiliation
ILORIN 240003 Nigeria senior registrar in obstetrics and gynaecology department UITH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The de-identified data of the participanst will be uploaded as well as the summary of the outcome of the study within 12months of completion of the study. Informed Consent Form,Statistical Analysis Plan,Study Protocol WITHIN 12MONTHS DELAYED CORD CLAMPING
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