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.: PACTR201711002786354 Date of Approval: 20/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of timing of cord clamping on neonatal hemoglobin and hematocrit values
Official scientific title The effect of timing of cord clamping on neonatal hemoglobin and hematocrit values
Brief summary describing the background and objectives of the trial BACKGROUND: In our setting the umbilical cord is clamped immediately after birth. This approach is thought to deprive the neonate of increased iron storage during the neonatal period. The negative effects of which are more profound in lower socioeconomic groups. Previous research has hypothesized DCC has benefits in reducing iron deficiency anemia in neonates JUSTIFICATION An observational study carried out at Kenyatta National hospital labour ward, averaged the mean umbilical cord clamping time to be 20 seconds falling under immediate cord clamping (ICC) category. Studies have shown Delayed cord clamping (DCC) can supply extra iron amounting to 40-50mg/kg. Most of which have been done in the developed world and Asia subcontinent. The study sought to investigate outcomes of hemoglobin and hematocrit levels among a population with higher incidence of anemia. If there were no difference in the two groups it would support ICC in situations of high patient turnover and poor nurse-patient ratio. Findings from this study will guide develop protocol. OBJECTIVE. To determine the effects of delayed umbilical cord clamping on hemoglobin and hematocrit level of term newborns. SPECIFIC Between term infants undergoing ICC and DCC To compare proportion of neonates who develop respiratory distress within the first 6 hours of life. To compare development of neonatal jaundice at day 3 and 7 of life
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Effect of timing of cord clamping on neonatal hemoglobin and hematocrit values,Neonatal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 20/11/2017
Actual trial start date 21/11/2017
Anticipated date of last follow up 25/11/2017
Actual Last follow-up date 25/11/2017
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants) 96
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P237/05/2017
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, 6 blocks of 16 each Allocation in identical sealed and opaque envelopes up to the time of intervention. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Immediate cord clamping Less than 30 seconds Immediate cord clamping within 30 minutes following vaginal delivery 48 Active-Treatment of Control Group
Experimental Group Delayed cord clamping More than 120 seconds Delayed cord clamping after 120 seconds following vaginal delivery. 48 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
CRITERIA:Full-term infants (>37 weeks gestation) of singleton pregnancies, with reassuring fetal status, undergoing spontaneous vertex delivery born to women of low risk pregnancies i.e. women aged 18-39, with no previous diagnosis of essential hypertension, renal disease, collagen-vascular disease, liver disease, cardiovascular disease, placenta previa, multiple gestation, intrauterine growth retardation, smoking, pregnancy-induced hypertension, premature rupture of membranes, or other previous documented conditions that pose a high risk of poor pregnancy outcome. Women willing to provide informed consent 1. Twin pregnancy, 2. History of post partumhaemorrhage (PPH), 3. Medical complications e.g. Pre-eclampsia, diabetes, renal disease, chronically medicated e.g. anticonvulsants, antidepressants, thyroid hormoneetc,4. Placental separation before delivery, 5. Caesarean section, 6. Tight nuchal cord necessitating early cutting, 7. Need for neonatal resuscitation8. Major congenital abnormalities (e.g. neural tube defects).9. Infants who weighed <2500 g, or with gestation below 37 weeks 18 Year(s) 39 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 04/10/2017 Kenyatta National hospital- University of Nairobi Ethics Research Committee
Ethics Committee Address
Street address City Postal code Country
Hospital road, Upper Hill NAIROBI 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neonatal hemoglobin levels Cord blood sample collected between 2-6 hours of life
Primary Outcome Neonatal hematocrit values Cord blood sampling will be collected 2-6 hours after birth.
Secondary Outcome Respiratory distress syndrome Development of symptoms evaluated within 6 hours of life
Secondary Outcome Neonatal jaundice Development of symptoms on 3rd and 7th day of life.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Hospital road, Upperhill Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Kenyatta National Hospital research department Hospital road, upperhill Nairobi 00202 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenyatta National Hospital research. Hospital road, upperhill Nairobi 00202 Kenya Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. Ojwang Hospital road, upperhill Nairobi 00202 Kenya
Prof Patrick Ndavi Hospital road, upperhill Nairobi 00202 Kenya
Dr. Allan Ikol Hospital road, Upper hill Nairobi 00202 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Carolyn Achieng' Aling' achiealing@gmail.com +254 726862227 Hospital road, Upper hill.
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Obstetric resident at Kenyatta National Hospital
Role Name Email Phone Street address
Public Enquiries Patrick Ndavi pmndavi@gmail.com +254 720797587 Hospital road, Upper hill.
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya University of Nairobi, department of Obstetrics and gynecology
Role Name Email Phone Street address
Scientific Enquiries Allan Ikol ikolke9082@gmail.com +254 722960817 Hospital road, Upper hill.
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Obstetrician at Kenyatta National Hospital
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information