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.: PACTR201607001684252 Date of Approval: 16/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Immediate versus delayed cord clamping in term babies born via caesarean section in rural Uganda
Official scientific title Immediate versus delayed cord clamping in term babies born via caesarean section in rural Uganda
Brief summary describing the background and objectives of the trial BACKGROUND: Delayed clamping of the umbilical cord (>1 minute) after delivery is associated with improved neonatal outcomes. OBJECTIVES: To investigate the effects of delayed umbilical cord clamping, compared with immediate clamping, on term babies born via caesarean section in rural Uganda.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal outcomes,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2016
Actual trial start date 10/04/2016
Anticipated date of last follow up 10/06/2016
Actual Last follow-up date 10/06/2016
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 51
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 Based on time at which caesarean was performed: 0-30 minutes past the hour = control group, 31-60 minutes past the hour = intervention group N/A Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Delayed umbilical cord clamping 90 seconds after delivery Clamping of the umbilical cord <10 seconds after delivery via caesarean section 27 Active-Treatment of Control Group
Control Group Immediate cord clamping N/A <10 seconds after delivery Immediate clamping (<10 seconds) of the umbilical cord after delivery via caesarean section 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Babies born at term (>37 weeks gestation) Singleton births Born via caesarean section Premature babies (<37 weeks gestation) Multiple births Baby requiring immediate resuscitation at delivery 0 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 29/03/2016 Kagando Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Kagando Hospital Kagando Private bag, Kasese Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Daily weights Day 1 Day 2 Day 3 Day 4 Day 5
Secondary Outcome APGAR Score 1 minute 5 minutes
Secondary Outcome Admission to NICU After birth
Secondary Outcome Length of stay on NICU After birth
Secondary Outcome O2 requirement During NICU admission
Secondary Outcome O2 requirement During NICU admission
Secondary Outcome Febrile? During NICU admission
Secondary Outcome ?Jaundice After birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kagando Hospital Kagando Hospital, Private bag Kasese Kagando Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
daniel cromb Kagando Hospital, Private bag Kasese Kagando Private bag, Kasese Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Daniel Cromb Kagando Hospital, Private bag Kasese Kagando Private bag, Kasese Uganda Hospital
COLLABORATORS
Name Street address City Postal code Country
Elizabeth O-Mahoney Kagando Hospital, Private bag Kasese Kagando Private bag, Kasese Uganda
Katie Rowland Kagando Hospital Kagando Private bag, Kasese Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Daniel Cromb daniel.cromb@nhs.net +447709112332 Kagando Hospital, Private bag Kasese
City Postal code Country Position/Affiliation
Kagando BR12UF United Kingdom Doctor
Role Name Email Phone Street address
Public Enquiries daniel cromb daniel.cromb@nhs.net +447709112332 Kagando Hospital, Private bag Kasese
City Postal code Country Position/Affiliation
Kagando BR12UF United Kingdom Doctor
Role Name Email Phone Street address
Scientific Enquiries daniel cromb daniel.cromb@nhs.net +447709112332 Kagando Hospital, Private bag Kasese
City Postal code Country Position/Affiliation
Kagando BR12UF United Kingdom Doctor
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