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Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32 weeks gestation): study protocol for a randomized controlled trial

Pushpa-Rajah, Angela; Bradshaw, Lucy; Dorling, Jon; Gyte, Gill; Mitchell, Eleanor J.; Thornton, Jim; Duley, Lelia

Authors

Angela Pushpa-Rajah

Jon Dorling

Gill Gyte

Eleanor J. Mitchell

JIM THORNTON jim.thornton@nottingham.ac.uk
Professor of Obstetrics and Gynaecology

Lelia Duley lelia.duley@nottingham.ac.uk



Abstract

Background: Preterm birth is the most important single determinant of adverse outcome in the United Kingdom; one in every 70 babies (1.4%) is born before 32 weeks (very preterm), yet these births account for over half of infant deaths.
Deferring cord clamping allows blood flow between baby and placenta to continue for a short time. This often leads to increased neonatal blood volume at birth and may allow longer for transition to the neonatal circulation. Optimal timing for clamping the cord remains uncertain, however. The Cochrane Review suggests that deferring umbilical cord clamping for preterm births may improve outcome, but larger studies reporting substantive outcomes and with long-term follow-up are needed. Studies of the physiology of placental transfusion suggest that flow in the umbilical cord at very preterm birth may continue for several minutes. This pilot trial aims to assess the feasibility of conducting a large randomised trial comparing immediate and deferred cord clamping in the UK.
Methods/Design: Women are eligible for the trial if they are expected to have a live birth before 32 weeks gestation. Exclusion criteria are known monochorionic twins or clinical evidence of twin-twin transfusion syndrome, triplet or higher order multiple pregnancy, and known major congenital malformation. The interventions will be cord clamping within 20 seconds compared with cord clamping after at least two minutes. For births with cord clamping after at least two minutes, initial neonatal care is at the bedside. For the pilot trial, outcomes include measures of recruitment, compliance with the intervention, retention of participants and data quality for the clinical outcomes.
Information about the trial is available to women during their antenatal care. Women considered likely to have a very preterm birth are approached for informed consent. Randomisation is close to the time of birth. Follow-up for the women is for one year, and for the children to two years of age (corrected for gestation at birth). The target sample size is 100 to 110 mother-infant pairs recruited over 12 months at eight sites.
Trial registration: ISRCTN21456601, registered on 28 February 2013.

Citation

Pushpa-Rajah, A., Bradshaw, L., Dorling, J., Gyte, G., Mitchell, E. J., Thornton, J., & Duley, L. (2014). Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32 weeks gestation): study protocol for a randomized controlled trial. Trials, 15(258), https://doi.org/10.1186/1745-6215-15-258

Journal Article Type Article
Acceptance Date May 28, 2014
Publication Date Jun 30, 2014
Deposit Date Feb 2, 2017
Publicly Available Date Feb 2, 2017
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 15
Issue 258
DOI https://doi.org/10.1186/1745-6215-15-258
Keywords pilot, randomised trial, preterm birth, umbilical cord clamping, neonatal care at the bedside
Public URL http://eprints.nottingham.ac.uk/id/eprint/39708
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-258
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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