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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, L., Sawyer, A., Mitchell, E., Armstrong-Buisseret, L., Ayers, S. ORCID: 0000-0002-6153-2460 and 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), 225.. doi: 10.1186/s13063-019-3325-4

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.

TRIAL REGISTRATION: ISRCTN21456601 . Registered on 28 February 2013.

Publication Type: Article
Publisher Keywords: Preterm birth, Umbilical cord-clamping, Neonatal care with cord intact, Experience, Clinical trials
Subjects: R Medicine > RG Gynecology and obstetrics
Departments: School of Health Sciences > Midwifery & Radiography
URI: http://openaccess.city.ac.uk/id/eprint/22102
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