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Women’s experiences of participating in a randomised trial comparing alternative policies for timing of cord clamping at very preterm birth: a questionnaire study

Bradshaw, Lucy; Sawyer, Alexandra; Mitchell, Eleanor; Armstrong-Buisseret, Lindsay; Ayers, Susan; Duley, Lelia

Authors

Alexandra Sawyer

Lindsay Armstrong-Buisseret

Susan Ayers

Lelia Duley



Abstract

Background
The Cord Pilot Trial compared two alternative policies for cord-clamping at very preterm birth at eight UK tertiary maternity units: clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and neonatal care after clamping. This paper reports views and experiences of the women who participated in the trial (261 randomised), based on data from two self-completed questionnaires.

Methods
Women were given or posted the first questionnaire between 4 and 8 weeks after birth, and posted a second similar questionnaire at 1 year. Both questionnaires included three questions about experiences of participating in the trial: (1) If time suddenly went backwards and you had to do it all over again, would you agree to participate in the Cord Pilot Trial?; (2) Please tell us if there was anything about the Cord Pilot Trial that you think could have been done better; and (3) Please tell us if there was anything about the Cord Pilot Trial, or your experiences of joining the trial, that you think were particularly good.

Results
One hundred and eighty-six women completed the first questionnaire and 133 completed the second. At both time points, 90% responded ‘probably‘ or ‘definitely‘ to participating in the trial again. More women randomised to deferred clamping responded ‘definitely yes‘ than those allocated immediate clamping (78% versus 67% first questionnaire). Women were positive about the level of information and explanations, the friendly and caring staff, and the benefits for their baby and others as a result of participating in the trial. Suggestions for how the trial could be done better included being approached earlier, better staff communication about the trial, more information overall, and better timing of follow-up.

Conclusions
Women were largely positive about participating in the trial. Nevertheless, they had suggestions for how the study could have been improved. These suggestions have implications for the design of future trials.

Citation

Bradshaw, L., Sawyer, A., Mitchell, E., Armstrong-Buisseret, L., Ayers, S., & Duley, L. (2019). Women’s experiences of participating in a randomised trial comparing alternative policies for timing of cord clamping at very preterm birth: a questionnaire study. Trials, 20(1), Article 225. https://doi.org/10.1186/s13063-019-3325-4

Journal Article Type Article
Acceptance Date Mar 25, 2019
Online Publication Date Apr 16, 2019
Publication Date 2019-12
Deposit Date May 28, 2019
Publicly Available Date Mar 29, 2024
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 20
Issue 1
Article Number 225
DOI https://doi.org/10.1186/s13063-019-3325-4
Keywords Preterm birth, Umbilical cord-clamping, Neonatal care with cord intact, Experience, Clinical trials
Public URL https://nottingham-repository.worktribe.com/output/2097467
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3325-4
Additional Information Received: 21 September 2018; Accepted: 25 March 2019; First Online: 16 April 2019; : Approval for this study was granted by the Nottingham 2 Research Ethics Committee (NRES reference 12/EM/0283). All participants gave written informed consent or oral assent prior to randomisation. Written consent was gained for participants giving oral assent prior to sending/giving out follow-up questionnaires.; : Not applicable.; : The authors declare that they have no competing interests.; : Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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