Plain English Summary
Background and study aims
In the UK one in every 70 babies is born more than eight weeks before their due date (very preterm). These very premature babies have immature lungs, and often need help with breathing, feeding and keeping warm. Usually at the birth of a premature baby, the umbilical cord is clamped and cut straight away, the baby is placed in a plastic wrap to retain heat, and then cared for by the neonatologist (a doctor or nurse who is a specialist in the care of newborn babies) on a special table at the side of the room. Clamping the cord stops blood flow between the placenta (organ that connects the developing foetus to the uterine wall to allow nutrient uptake, waste elimination, and gas exchange via the mother's blood supply) and the baby. If the cord is not clamped straight away, this blood flow may continue for several minutes, potentially transferring blood from the placenta to the baby. Waiting a few minutes before clamping the cord may help the baby to adjust to life outside the womb. As it is not known when the best time to clamp the cord for very preterm births is, this study is being done. The study is comparing clamping the cord after at least two minutes (deferred cord clamping) with clamping the cord within 20 seconds. For deferred cord clamping, care for the baby will be provided at the woman's bedside. If the cord is clamped within 20 seconds, the neonatal team will choose whether care for the baby is provided at the woman's bedside or at the side of the room. In both cases the baby will receive the same care at birth, just in different places. This is an initial small study, to help decide whether it would be possible to do a much larger trial. Finding out which of the two approaches to care is better for babies and their mothers will need the large study. Information from this study will help us to conduct the large study well.
Who can participate?
Women who are expected to give birth more than eight weeks before their due date.
What does the study involve?
Women who take part in the study will be randomly allocated to one of the two groups (1) cord clamping after at least two minutes, or (2) cord clamping within 20 seconds. If the cord is clamped after at least two minutes, care for the baby will be provided at the bedside. If the cord is clamped within 20 seconds, the neonatal team will choose whether care for the baby is provided at the woman's bedside or at the side of the room. Women who take part in the trial will be asked to complete a short postal questionnaire six weeks after the birth, and another one year after the birth. Around the child's second birthday the parents will be contacted to complete another questionnaire and to arrange a visit to find out how their child is doing.
Where is the study run from?
Nottingham Clinical Trials Unit, Nottingham Health Science Partners, Queen's Medical Centre, Derby Road
Nottingham, NG7 2UH
When is the study starting and how long is it expected to run for?
Originally the study recruitment was planned to run from April 2013 until March 2014. However, recruitment was extended while funding was sought for the main trial. When this application for funding was rejected in February 2015, recruitment to the Cord Pilot Trial was closed.
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Lindsay Armstrong-Buisseret, Trial Manager
Prof Lelia Duley
Nottingham Clinical Trials Unit
Nottingham Health Science Partners
Queen's Medical Centre
+44 (0)115 884 4938
13070; 108150; 12OB006
Immediate cord clamping versus deferred cord clamping for preterm birth before 32 weeks gestation: a pilot randomised trial
The primary hypothesis is that for children born before 32 weeks gestation immediate cord clamping is associated with higher death or neurosensory disability at two years of age (corrected for gestation at birth) than deferred cord clamping. A trial to test this hypothesis would need to be large and multicentre. This protocol is for a pilot trial to assess the feasibility such a study.
NRES Committee East Midlands - Nottingham 2, 23/07/2012, ref: 12/EM/0283
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Topic: Reproductive Health and Childb, Generic Health Relevance and Cross Cutting Themes; Subtopic: Reproductive Health and Childb (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Reproductive Health & Childbirth, Paediatrics
1. Deferred cord clamping: clamping the cord after at least two minutes
2. Immediate cord clamping: clamping the cord within 20 seconds
Primary outcome measures
Feasibility outcomes for the original pilot trial:
1. Number of women recruited in each hospital
2. Proportion of potentially eligible women recruited
3. Reasons for non-recruitment (medical, parental, logistic, other)
4. Spectrum of gestational age and neonatal outcome among recruits
5. Compliance with the trial interventions, and reasons for non-compliance
6. Completeness of data collection for main outcomes
7. Views of women and their partners on recruitment, randomisation and the interventions
8. Proportion lost to follow up after discharge from hospital, and reasons for loss to follow up
As the primary outcomes planned for the main Cord Trial were death and intraventricular haemorrhage, these were the pre-specified main outcomes for the analysis by allocated group for the Cord Pilot Trial.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
Overall trial end date
Participant inclusion criteria
Women will be eligible for the study if they are likely to have a livebirth before 32 weeks gestation, regardless of mode of birth or whether cephalic or breech presentation.
Target number of participants
UK Sample Size: 261
Participant exclusion criteria
1. Monochorionic twins (from an ultrasound scan) or clinical evidence of twin-twin transfusion syndrome
2. Triplets or higher order multiple pregnancy
3. Known congenital malformation
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Nottingham Clinical Trials Unit
Nottingham University Hospitals NHS Trust (UK)
c/o Dr Maria Koufali
Research & Innovation
Nottingham Integrated Clinical Research Centre
Queen's Medical Centre Campus
National Institute for Health Research (UK) - Programme Grants for Applied Research; Grant Codes: RP-PG-0609-10107
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Outcome data at discharge from hospital to be published in 2016. Follow-up of women at 1 year is expected to be published in 2017 and assessment of the children at 2 years of age (corrected for gestation at birth) in 2018.
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Pushpa-Rajah A, Bradshaw L, Dorling J, Gyte G, Mitchell EJ, Thornton J, Duley L, , Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32 weeks gestation): study protocol for a randomized controlled trial., Trials, 2014, 15, 258, doi: 10.1186/1745-6215-15-258.
Bradshaw LE, Pushpa-Rajah A, Dorling J, Mitchell EJ, Duley L; Cord Pilot Trial Collaborative Group, Cord pilot trial: update to randomised trial protocol., Trials, 2015, 16, 1, 407, doi: 10.1186/s13063-015-0936-2.
- ISRCTN21456601_PROTOCOL_v6.2_08Sep16.pdf Uploaded 10/11/2016