Skip to main content
Top
Published in: BMC Pregnancy and Childbirth 1/2019

Open Access 01-12-2019 | Affective Disorder | Research article

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

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

Published in: BMC Pregnancy and Childbirth | Issue 1/2019

Login to get access

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
Appendix
Available only for authorised users
Literature
1.
go back to reference Saigal S, Doyle LW. An overview of mortality and sequelae of preterm birth from infancy to adulthood. Lancet. 2008;371(9608):261–9.CrossRef Saigal S, Doyle LW. An overview of mortality and sequelae of preterm birth from infancy to adulthood. Lancet. 2008;371(9608):261–9.CrossRef
2.
go back to reference Henderson J, Carson C, Redshaw M. Impact of preterm birth on maternal well-being and women's perceptions of their baby: a population-based survey. BMJ Open. 2016;6:e012676. Henderson J, Carson C, Redshaw M. Impact of preterm birth on maternal well-being and women's perceptions of their baby: a population-based survey. BMJ Open. 2016;6:e012676.
3.
go back to reference POPPY Steering group: family-centred care in neonatal units. A summary of research results and recommendations from the POPPY project. London: NCT; 2009. POPPY Steering group: family-centred care in neonatal units. A summary of research results and recommendations from the POPPY project. London: NCT; 2009.
4.
go back to reference Rabe H, Diaz-Rossello JL, Duley L, Dowswell T. Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes. Cochrane Database Syst Rev. 2012;8:CD003248. Rabe H, Diaz-Rossello JL, Duley L, Dowswell T. Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes. Cochrane Database Syst Rev. 2012;8:CD003248.
5.
go back to reference Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018;218(1):1–18.PubMedCrossRef Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018;218(1):1–18.PubMedCrossRef
6.
go back to reference Pushpa-Rajah A, Bradshaw L, Dorling J, Gyte G, Mitchell E, Thornton J, Duley L, on behalf of the cord pilot trial collaborative group. Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32weeks gestation): study protocol for a randomized controlled trial. Trials. 2014;15(1):258.PubMedPubMedCentralCrossRef Pushpa-Rajah A, Bradshaw L, Dorling J, Gyte G, Mitchell E, Thornton J, Duley L, on behalf of the cord pilot trial collaborative group. Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32weeks gestation): study protocol for a randomized controlled trial. Trials. 2014;15(1):258.PubMedPubMedCentralCrossRef
7.
go back to reference Bradshaw LE, Pushpa-Rajah A, Dorling J, Mitchell EJ, Duley L. Cord pilot trial: update to randomised trial protocol. Trials. 2015;16(1):1–3.CrossRef Bradshaw LE, Pushpa-Rajah A, Dorling J, Mitchell EJ, Duley L. Cord pilot trial: update to randomised trial protocol. Trials. 2015;16(1):1–3.CrossRef
8.
go back to reference Duley L, Dorling J, Pushpa-Rajah A, Oddie SJ, Yoxall CW, Schoonakker B, Bradshaw L, Mitchell EJ, Fawke JA. Cord pilot trial collaborative G: randomised trial of cord clamping and initial stabilisation at very preterm birth. Arch Dis Child Fetal Neonatal Ed. 2018;103(1):F6–F14.PubMedCrossRef Duley L, Dorling J, Pushpa-Rajah A, Oddie SJ, Yoxall CW, Schoonakker B, Bradshaw L, Mitchell EJ, Fawke JA. Cord pilot trial collaborative G: randomised trial of cord clamping and initial stabilisation at very preterm birth. Arch Dis Child Fetal Neonatal Ed. 2018;103(1):F6–F14.PubMedCrossRef
9.
go back to reference Sawyer A, Ayers S, Bertullies S, Thomas M, Weeks AD, Yoxall CW, Duley L. Providing immediate neonatal care and resuscitation at birth beside the mother: parents' views, a qualitative study. BMJ Open. 2015;5(9):e008495.PubMedPubMedCentralCrossRef Sawyer A, Ayers S, Bertullies S, Thomas M, Weeks AD, Yoxall CW, Duley L. Providing immediate neonatal care and resuscitation at birth beside the mother: parents' views, a qualitative study. BMJ Open. 2015;5(9):e008495.PubMedPubMedCentralCrossRef
10.
go back to reference Yoxall CW, Ayers S, Sawyer A, Bertullies S, Thomas M, Weeks A, Duley L. Providing immediate neonatal care and resuscitation at birth beside the mother: clinicians' views, a qualitative study. BMJ Open. 2015;5(9):e008494.PubMedPubMedCentralCrossRef Yoxall CW, Ayers S, Sawyer A, Bertullies S, Thomas M, Weeks A, Duley L. Providing immediate neonatal care and resuscitation at birth beside the mother: clinicians' views, a qualitative study. BMJ Open. 2015;5(9):e008494.PubMedPubMedCentralCrossRef
11.
go back to reference Duley L, Pushpa-Rajah A, Bradshaw L, Dorling J, Mitchell E. When an external pilot is successful, should it be possible to transform it into an internal pilot by continuing recruitment into the full trial is ready? A case study of the cord pilot trial. Trials. 2015;16(2):P15.PubMedCentralCrossRef Duley L, Pushpa-Rajah A, Bradshaw L, Dorling J, Mitchell E. When an external pilot is successful, should it be possible to transform it into an internal pilot by continuing recruitment into the full trial is ready? A case study of the cord pilot trial. Trials. 2015;16(2):P15.PubMedCentralCrossRef
12.
go back to reference Sawyer A, Chhoa C, Ayers S, Pushpa-Rajah A, Duley L. Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study. Trials. 2017;18(1):422.PubMedPubMedCentralCrossRef Sawyer A, Chhoa C, Ayers S, Pushpa-Rajah A, Duley L. Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study. Trials. 2017;18(1):422.PubMedPubMedCentralCrossRef
13.
go back to reference Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.PubMedCrossRef Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.PubMedCrossRef
14.
go back to reference Sawyer A, Rabe H, Abbott J, Gyte G, Duley L, Ayers S. The very preterm birth collaborative G: measuring parents' experiences and satisfaction with care during very preterm birth: a questionnaire development study. BJOG Int J Obstet Gynaecol. 2014;121(10):1294–301.CrossRef Sawyer A, Rabe H, Abbott J, Gyte G, Duley L, Ayers S. The very preterm birth collaborative G: measuring parents' experiences and satisfaction with care during very preterm birth: a questionnaire development study. BJOG Int J Obstet Gynaecol. 2014;121(10):1294–301.CrossRef
15.
go back to reference Carter J, Mulder R, Bartram A, Darlow B. Infants in a neonatal intensive care unit: parental response. Arch Dis Child Fetal Neonatal Ed. 2005;90(2):F109–13.PubMedPubMedCentralCrossRef Carter J, Mulder R, Bartram A, Darlow B. Infants in a neonatal intensive care unit: parental response. Arch Dis Child Fetal Neonatal Ed. 2005;90(2):F109–13.PubMedPubMedCentralCrossRef
16.
go back to reference Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the hospital anxiety and depression scale. An updated literature review. J Psychosom Res. 2002;52(2):69–77.PubMedCrossRef Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the hospital anxiety and depression scale. An updated literature review. J Psychosom Res. 2002;52(2):69–77.PubMedCrossRef
17.
go back to reference Antenatal and Postnatal Mental Health. Clinical Management and Service Guidance: Updated edition. In: Clinical guideline [CG192]. Leicester (UK): National Institute for Health and Clinical Excellence; 2014. Antenatal and Postnatal Mental Health. Clinical Management and Service Guidance: Updated edition. In: Clinical guideline [CG192]. Leicester (UK): National Institute for Health and Clinical Excellence; 2014.
18.
go back to reference Pace CC, Spittle AJ, Molesworth CL, et al. Evolution of depression and anxiety symptoms in parents of very preterm infants during the newborn period. JAMA Pediatr. 2016;170(9):863–70.PubMedCrossRef Pace CC, Spittle AJ, Molesworth CL, et al. Evolution of depression and anxiety symptoms in parents of very preterm infants during the newborn period. JAMA Pediatr. 2016;170(9):863–70.PubMedCrossRef
19.
go back to reference Vigod S, Villegas L, Dennis C-L, Ross L. Prevalence and risk factors for postpartum depression among women with preterm and low-birth-weight infants: a systematic review. BJOG Int J Obstet Gynaecol. 2010;117(5):540–50.CrossRef Vigod S, Villegas L, Dennis C-L, Ross L. Prevalence and risk factors for postpartum depression among women with preterm and low-birth-weight infants: a systematic review. BJOG Int J Obstet Gynaecol. 2010;117(5):540–50.CrossRef
20.
go back to reference Redshaw M, Henderson J: Safely delivered: a national survey of women’s experience of maternity care 2014. In. Oxford; 2015. Redshaw M, Henderson J: Safely delivered: a national survey of women’s experience of maternity care 2014. In. Oxford; 2015.
21.
go back to reference Sawyer A, Ayers S, Abbott J, Gyte G, Rabe H, Duley L. Measures of satisfaction with care during labour and birth: a comparative review. BMC Pregnancy Childbirth. 2013;13(1):108.PubMedPubMedCentralCrossRef Sawyer A, Ayers S, Abbott J, Gyte G, Rabe H, Duley L. Measures of satisfaction with care during labour and birth: a comparative review. BMC Pregnancy Childbirth. 2013;13(1):108.PubMedPubMedCentralCrossRef
22.
go back to reference Robinson EJ, Kerr CE, Stevens AJ, Lilford RJ, Braunholtz DA, Edwards SJ, Beck SR, Rowley MG. Lay public's understanding of equipoise and randomisation in randomised controlled trials. Health Technol Assess. 2005;9(8):1–192 iii-iv.PubMedCrossRef Robinson EJ, Kerr CE, Stevens AJ, Lilford RJ, Braunholtz DA, Edwards SJ, Beck SR, Rowley MG. Lay public's understanding of equipoise and randomisation in randomised controlled trials. Health Technol Assess. 2005;9(8):1–192 iii-iv.PubMedCrossRef
23.
go back to reference Wilman E, Megone C, Oliver S, Duley L, Gyte G, Wright J. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research. Trials. 2015;16:502.PubMedPubMedCentralCrossRef Wilman E, Megone C, Oliver S, Duley L, Gyte G, Wright J. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research. Trials. 2015;16:502.PubMedPubMedCentralCrossRef
Metadata
Title
Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year
Authors
Lucy Bradshaw
Alexandra Sawyer
Lindsay Armstrong-Buisseret
Eleanor Mitchell
Susan Ayers
Lelia Duley
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2019
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-019-2223-9

Other articles of this Issue 1/2019

BMC Pregnancy and Childbirth 1/2019 Go to the issue