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.: PACTR201906770028735 Date of Approval: 12/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Umbilical Cord Milking versus Delayed Cord Clamping on Selected Hematological and Clinical Parameters in Preterm Neonates at Kenyatta National Hospital: Randomized Controlled Trial.
Official scientific title Effect of Umbilical Cord Milking versus Delayed Cord Clamping on Selected Hematological and Clinical Parameters in Preterm Neonates at Kenyatta National Hospital: A Randomized Controlled Trial. .
Brief summary describing the background and objectives of the trial Background: The placenta is a useful reservoir of fetal blood that can serve to alleviate anaemia of prematurity, a condition prevalent in almost all premature neonates. Immediate cord clamping is a routine practice worldwide, despite current evidence on the benefits of providing placental transfusion to the new born. Umbilical cord milking (UCM) and delayed cord clamping (DCC) are two strategies of providing placental transfusion. Major obstetric and gynaecological societies are now recommending delayed cord clamping. Umbilical cord milking is a cost effective intervention and can be considered for faster placental transfer when delayed cord clamping cannot be performed, such as when a neonate requires resuscitation. Fifteen countries, including Kenya, are responsible for over two thirds of the world¿s preterm births and its subsequent complications, specifically anaemia.The findings of this study will inform strategies to reduce neonatal anaemia in Kenya. This study aims to evaluate whether umbilical cord milking is comparable in benefits to delayed cord clamping and hence may be beneficial to premature neonates where every second after birth is essential. Objective: To determine the effects of umbilical cord milking versus delayed umbilical cord clamping on selected haematological and clinical parameters in preterm neonates.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied anaemia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 18/03/2018
Actual trial start date
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 280
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 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 delayed cord clamping sixty seconds the cord will be clamped 60 seconds after birth 140 Active-Treatment of Control Group
Experimental Group umbilical cord milking four times the umbilical cord will be held as close to the placenta as possible and milking will be carried out four times toward the neonate. 140
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Mother-baby pairs between 28 to <37 weeks gestational age. Gestational age will be confirmed by use of Last Menstrual Period dating or if available a first trimester ultrasound scan will be used. After delivery a Ballard score will be done at 24 hours to ascertain gestational age. ¿Spontaneous or provider initiated preterm births. ¿Women who provide Informed consent. ¿Multiple gestations. ¿Neonates with congenital abnormalities(e.g. neural tube defects) incompatible with extra uterine life or requiring immediate resuscitation ¿Red cell isoimmunisation. ¿HIV and VDRL positive women. ¿Ante partum haemorrhage including placenta accrete or placenta abruption. ¿Need for neonatal resuscitation as determined during the antenatal period. ¿Tight nuchal cord necessitating early cord clamping and cutting. ¿Patients who are incapable of informed consent (severely ill), or unwilling to undergo randomization. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(s) 64 Year(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 08/02/2018 Kenyatta National Hospital University of Nairobi Ethics and Research Committe
Ethics Committee Address
Street address City Postal code Country
hospital road, upperhill nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Determine and compare the mean haemoglobin and haematocrit values at 24 hours of life. 24 hours of life
Primary Outcome Determine the incidence rate of neonatal polycythemia at 24 hours of life. 24 hours of life
Primary Outcome 3. Determine the incidence rate of neonatal jaundice within the first week of life. 7 days after birth
Secondary Outcome Determine the incidence rate of neonatal anaemia within the first 24 hours of life. 24 hours after birth
Secondary Outcome primary post partum haemorrhage 24 hours after birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kenyatta national hospital hospital road,upper hill nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
kenyatta national hospital research and programs hospital road nairobi 00200 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mandeep sura westlands nairobi 46116-00100 Kenya Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr Alfred Osoti University of Nairobi nairobi 30197 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mandeep sura suramandeep@gmail.com +254722775150 westlands
City Postal code Country Position/Affiliation
nairobi 00100 Kenya
Role Name Email Phone Street address
Public Enquiries mandeep sura suramandeep@gmail.com +254722775150 westlands
City Postal code Country Position/Affiliation
nairobi 46116-00100 Kenya
Role Name Email Phone Street address
Scientific Enquiries mandeep sura suramandeep@gmail.com +254722775150 westlands
City Postal code Country Position/Affiliation
nairobi 00100 Kenya
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes there is a plan to make IPD available. Individual participant data that underlie the study results reported in this article, after de-identification (text, tables, figures and appendices) will be provided. Data will become available within 3 months to 5 years after study publication. Additional documents to be provided are: The study protocol, informed consent form and clinical study report. The information will be shared with researchers who provide a methodologically sound proposal. Analysis of the information can be used to meet the aims in the approved proposal. Proposals should be directed to suramandeep@gmail.com to gain access, data requesters will need to sign a data access agreement. Clinical Study Report,Informed Consent Form,Study Protocol IPD and any supporting information will become available beginning 3 months and 5 years following publication. Proposals should be directed to suramandeep@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data is available for 5 years at a third party website (Link to be provided later). Information will be shared with researchers who provide a methodologically sound proposal. Analysis of the information can be used to meet the aims in the approved proposal.
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