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.: PACTR202010878847651 Date of Approval: 05/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of time of umbilical cord clamping on serum bilirubin level among full-term newborns.
Official scientific title Effect of time of umbilical cord clamping on serum bilirubin level among full-term newborns born in Black Lion Specialized Hospital, Addis Ababa Ethiopia
Brief summary describing the background and objectives of the trial The right timing for umbilical cord clamping has been a topic of interest for a very long time. In these days, the recommended procedure of the delayed cord clamping above one minute has its short and long-term benefits and possible counter effect on elevated serum bilirubin level/hyperbilirubinemia. This study aims to evaluate the effect of the time of cord clamping on the elevated serum bilirubin level and proportion of neonates who develop hyperbilirubinemia/pathologic jaundice within 24 hours.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial cause and effect relationship
Anticipated trial start date 08/04/2019
Actual trial start date 06/05/2019
Anticipated date of last follow up 01/05/2019
Actual Last follow-up date 14/10/2019
Anticipated target sample size (number of participants) 155
Actual target sample size (number of participants) 141
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Immediate cord clamping ICC <30 seconds The immediate clamping group will receive an intervention of clamping and cutting the umbilical cord immediately after expulsion/delivery of the baby. These group will receive the cord management as usual in the hospital. 47 Dose Comparison
Experimental Group Intermediate cord clamping 30-60 seconds Intermediate clamping group will receive an intervention of clamping and cutting the umbilical cord intermediately between 30-60 seconds after birth by placing the newborn on the mother abdomen and prevent it from hypothermia. These group will be closely monitored for the specific seconds to clamp the cord by the assigned supervisor. 47
Experimental Group Delayed cord clamping DCC 61-180 seconds The DCC group will receive a similar intervention except that the clamping of the cord time will be between 61-180 seconds and the baby will be well wrapped with a towel and the minute will be monitored by the supervisor and he/she will communicate the attendant when it is time for the intervention. 47
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A live newborn with a gestational age of 37-42 weeks diagnosed with the first day of last menstrual period (LMP) or ultrasound. A live newborn who has no gross complications related to pregnancy and delivery (including mal-presentation, fetal distress, and congenital malformations). A live newborn with whom the mother agreed and give informed consent. A live newborn with whom body weight is above 2500gm and below 4000gm at birth. A live newborn with whom first and 5th minute Apgar score ≥ 7. A mother with rhesus negative blood group or any medical or obstetric complications (hepatitis, HIV/AIDS, hypertensive disorders of pregnancy, diabetes and severe anemia). A newborn with known congenital malformation during pregnancy or delivery. Confirmed multiple pregnancy and mal-presentation. Neonate that require immediate resuscitation. Newborns with a body weight of above 4100gm. Newborns with their gestational age at birth is >42 weeks. New born: 0 Day-1 Month 1 Day(s) 2 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 28/01/2019 Addis Ababa university college of health science school of public health institutional review board
Ethics Committee Address
Street address City Postal code Country
Zambia Street Addis Ababa 5657 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum bilirubin level of the newborn and related hyperbilirubinemia that requires phototherapy. At 24 hours of age
Secondary Outcome The proportion of newborns that required a phototherapy treatment. 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Black lion Specialized Hospital Zambia street Addis Ababa 5657 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Addis Ababa University college of health sciences Zambia Addis Ababa 5657 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor UNFPA Ethiopia Menelik II Avenue Addis Ababa 5580 Ethiopia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr. Mulugeta Betre Gebremariam Zambia st. Addis Ababa 5657 Ethiopia
Mr. Abiy Seifu Zambia St. Addis Ababa 5657 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Biruk Hailu Tesfaye brkhailu41@gmail.com +251912128858 Sudan st.
City Postal code Country Position/Affiliation
Addis Ababa 1234 Ethiopia Student
Role Name Email Phone Street address
Public Enquiries Biruk Hailu Tesfaye brkhailu41@gmail.com +251912128858 Sudan St.
City Postal code Country Position/Affiliation
Addis Ababa 22345 Ethiopia Researcher
Role Name Email Phone Street address
Scientific Enquiries Biruk Hailu Tesfaye biruk.hailu@moh.gov.et +251924369401 Zambia st.
City Postal code Country Position/Affiliation
Addis Ababa 22345 Ethiopia researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. Will individual participant data be available (including data dictionaries)?  Yes 2. What data in particular will be shared?  Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) 3. What other documents will be available?  The study protocol, Statistical Analysis Plan, Analytic Code 4. When will data be available (start and end date)?  Beginning 3 months and ending 5 years following article publication 5. With who?  Researchers who provide a methodologically sound proposal 6. For what types of analyses?  To achieve aims in the approved proposal 7. By what mechanism will the date be made available?  The proposal should be directed to brkhailu41@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website (Link to be included). Clinical Study Report 6 months free
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 16/09/2020 16/09/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 05/10/2020 Result - 16/09/2020 Result - 16/09/2020 Result - 16/09/2020 Result - 16/09/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information