妇女参与比较极早产时不同脐带夹闭时机政策的随机试验的体验：问卷调查研究。

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

机构信息

Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, NG7 2UH, UK.

School of Health Sciences, University of Brighton, Falmer, BN1 9PH, UK.

出版信息

Trials. 2019 Apr 16;20(1):225. doi: 10.1186/s13063-019-3325-4.

DOI:10.1186/s13063-019-3325-4

PMID:30992034

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6469101/

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.

摘要

背景

Cord Pilot 试验比较了在英国 8 家三级妇产医院对极早产儿进行断脐的两种替代方案：在至少 2 分钟后夹闭脐带并保持新生儿脐带完整，或在 20 秒内夹闭脐带并在夹闭后进行新生儿护理。本文根据参加该试验的 261 名随机患者的数据（2 份自我完成的问卷），报告了这些女性的观点和经验。

方法

分娩后 4 至 8 周，医护人员向这些女性发放或邮寄第一份问卷，在 1 年后邮寄第二份类似的问卷。两份问卷均包含 3 个关于参与试验经历的问题：（1）如果时间突然倒退，您是否愿意再次参加 Cord Pilot 试验？（2）请告诉我们，您认为试验有哪些方面可以做得更好？（3）请告诉我们，您认为试验过程中或参加试验的经历有哪些特别好的方面？

结果

186 名女性完成了第一份问卷，133 名女性完成了第二份问卷。在两个时间点，90%的女性回答“可能”或“肯定”会再次参加试验。与立即夹闭组相比，随机分配至延迟夹闭组的女性回答“非常肯定”的比例更高（第一次问卷时为 78%，而第一次问卷时为 67%）。女性对信息和解释的水平、友好和关怀的医护人员，以及参与试验对婴儿和他人的好处表示肯定。如何改进试验的建议包括更早接触、医护人员更好地沟通试验情况、提供更多信息以及更好地安排随访时间。