Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year

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

Abstract

Background
The Cord Pilot Trial compared two alternative policies for cord clamping at very preterm birth at eight UK maternity units: clamping after at least 2 min and immediate neonatal care (if needed) with cord intact, or clamping within 20 s and neonatal care after clamping. This paper reports follow-up of the women by two self-completed questionnaires up to one year after the birth.

Methods
Women were given or posted the first questionnaire between four and eight weeks after birth, usually before their baby was discharged, and were posted a second similar questionnaire at one year. The questionnaire included the Hospital Anxiety and Depression Scale; the Preterm Birth Experience and Satisfaction Scale (P-BESS) and questions about their baby’s feeding.

Results
Of 261 women randomised (132 clamping ≥2 min, 129 clamping ≤20 s), six were excluded as birth was after 35+ 6 weeks (2, 4 in each group respectively). Six were not sent either questionnaire. The first questionnaire was given/sent to 244 and returned by 186 (76%) (79, 74%). The second, at one year, was sent to 242 and returned by 133 (55%) (66, 43%).

On the first questionnaire, 89 (49%) had a score suggestive of an anxiety disorder, and 55 (30%) had a score suggestive of depression. Satisfaction with care at birth was high: median total P-BESS score 77 [interquartile range 68 to 84] (scale 17 to 85). There was no clear difference in anxiety, depression, or satisfaction with care between the two allocated groups. The median number of weeks after birth women breastfed/expressed was 16 (95% confidence interval (CI) 13 to 20, n = 119) for those allocated clamping ≥2 min and 12 (95% CI 11 to 16, n = 103) for those allocated clamping ≤20 s.

Conclusions
The response rate was higher for the earlier questionnaire than at one year. A high proportion of women reported symptoms of anxiety or depression, however there were no clear differences between the allocated groups. Most women reported that they had breastfed or expressed milk and those allocated deferred cord clamping reported continuing this for slightly longer.

Trial registration
ISRCTN 21456601, registered 28th February 2013, http://www.isrctn.com/ISRCTN21456601

Citation

Bradshaw, L., Sawyer, A., Armstrong-Buisseret, L., Mitchell, E., Ayers, S., & Duley, L. (2019). Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year. BMC Pregnancy and Childbirth, 19, Article 78. https://doi.org/10.1186/s12884-019-2223-9

• Journal Article Type: Article
• Acceptance Date: Feb 15, 2019
• Online Publication Date: Feb 21, 2019
• Publication Date: Feb 21, 2019
• Deposit Date: Feb 28, 2019
• Publicly Available Date: Feb 28, 2019
• Journal: BMC Pregnancy and Childbirth
• Electronic ISSN: 1471-2393
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 19
• Article Number: 78
• DOI: https://doi.org/10.1186/s12884-019-2223-9
• Keywords: Preterm birth; Umbilical cord clamping; Neonatal care with cord intact; Clinical trial; Follow up for women
• Public URL: https://nottingham-repository.worktribe.com/output/1592023
• Publisher URL: https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-019-2223-9
• Additional Information: Received: 14 September 2018; Accepted: 15 February 2019; First Online: 21 February 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.
• Contract Date: Feb 28, 2019