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.: PACTR201906668876480 Date of Approval: 19/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title OFOJEBE cord Trial
Official scientific title Effect of immediate and delayed umbilical cord clamping on haemoglobin and bilirubin values of term newborn: a randomised control trial
Brief summary describing the background and objectives of the trial Anaemia is one of the common medical disorders in infants of developing countries. An important step directed towards reducing anaemia in infancy can be taken during childbirth. Delayed cord clamping (DCC) can supply additional volume of blood to the fetus. This extra blood can add extra iron to the fetus and help prevent iron deficiency anaemia in infancy. Timing for umbilical cord clamping varies, usually from immediately after birth to about 180 seconds or when the cord has stopped pulsating. Although controversies exist on the optimal timing for umbilical cord clamping after birth, there is currently a dearth of studies in Nigeria examining the effect of delayed and immediate umbilical clamping (ICC) on maternal and fetal outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OFOJEBE Cord Trial
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2019
Actual trial start date 01/07/2019
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date 30/09/2020
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants) 102
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 created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group early umbilical cord clamping group Clamping once Clamping within 0-15 seconds . In the immediate cord clamping group the cord was clamped within 15 seconds after delivery. Following clamping and cutting of the cord, 3 mls of cord blood was collected for haemoglobin and bilirubin estimation. 51
Control Group Delayed umbilical cord clamping group Clamping once clamping after 60 seconds The intervention in the delayed cord clamping group consisted of delay in clamping the cord for 60 seconds. Following clamping and cutting of the cord, 3 mls of cord blood was collected for haemoglobin and bilirubin estimation. 51 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Women in labour at a gestational age from 37 completed weeks to 42weeks. 2. Women who gave consent. 3. Singleton pregnancy 4. Healthy pregnant women 5. Expected vaginal delivery 1. Women who withheld consent 2. Women who were retroviral disease positive 3. Diabetes mellitus 4. Rhesus isoimmunisation 5. Women at risk of postpartum haemorrhage 6. Pre eclampsia 7. Prolonged rupture of membranes 8. Fetal distress, babies that need resuscitation. 9. Babies with congenital malformation. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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
No 10/06/2019 NAUTH ETHICS committee
Ethics Committee Address
Street address City Postal code Country
49 Nnewi Onitsha road Nnewi 435001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome infant haemoglobin status At 0 and 48 hours post delivery
Primary Outcome infant bilirubin status At 0 and 48 hours after birth
Secondary Outcome polycythaemia 48 Hours of birth
Secondary Outcome need for phototherapy 48 hours post delivery
Secondary Outcome maternal postpartum haemorrhage At 0 and 48 hours post delivery
Secondary Outcome respiratory symptoms At 48 hours after birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital 49 Nnewi Onitsha road Nnewi 435001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital 49 Nnewi Onitsha Road Nnewi 435001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Ofojebe Chukwuemeka 49 Nnewi Onitsha road Nnewi 435001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
DR Joseph Ikechebelu 49 Nnewi Onitsha Road Nnewi 435001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CHUKWUEMEKA OFOJEBE ofojtico@gmail.com +2348035805184 49 Nnewi Onitsha road
City Postal code Country Position/Affiliation
Nnewi 435001 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries Okaforcha Emmanuel emmanuelokaforwhite@gmail.com +2348036721488 49 Nnewi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi 435001 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries GEORGE ELEJE georgel21@yahoo.com +2348068117444 49 Nnewi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi Nigeria CONSULTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes PROFORMA RESEARCH PROFORMA THE EFFECTS OF IMMEDIATE AND DELAYED UMBILICAL CORD CLAMPING ON HAEMOGLOBIN AND BILIRUBIN STATUS OF TERM NEW BORN AT NAUTH, NNEWI. 1. Phone number of patients……………………………………………………. 2. Folder Number……………………………………………………………………… 3. Date of initial presentation…………………………………………………… 4. Age…………………………weight………………………Length……………………….. 5. Parity………………………PCV…………………………………………………………….. 6. Religion…………………………………………………………………………………….. 7. Highest Educational level………………………………………………………. 8. LMP………………………………………………………………………………………. 9. Gestational Age(weeks)…………………………………………………………. 10. Marital status………………………………………………………………………… 11. Booking status: Booked[ ] Unbooked[ ] 12. Date of delivery………………………………………………………………………. 13. Mode of delivery………………………………………………………………….. 14. Time of cord clamping; 0-15secs[ ] 60secs[ ] 15. Duration of third stage of labour…………. 16. Any need for a repeat uterotonic yes[ ] No[ ] 17. Estimated amount of blood loss………………mls 18. APGAR score of baby………………………………………………… 19. Birth weight of baby…………………………………………………. 20. Haemoglobin concentration of baby at 48hours…………. 21. Bilirubin value at 48 hours………………………………………… 22. Neonatal jaundice yes[ ] No[ ] 23. Phototherapy yes[ ] No[ ] 24. Admission into special care baby unit……………………….. 25. Cord blood bilirubin ………………….hb……………………….. Informed Consent Form JULY 2019 TO JANUARY 2020 OPEN
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