Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation–effectiveness, randomised controlled pilot trial in the UK
Autoři:
Cristina Fernandez Turienzo aff001; Debra Bick aff002; Annette L. Briley aff003; Mary Bollard aff004; Kirstie Coxon aff005; Pauline Cross aff006; Sergio A. Silverio aff001; Claire Singh aff001; Paul T. Seed aff001; Rachel M. Tribe aff001; Andrew H. Shennan aff001; Jane Sandall aff001;
Působiště autorů:
Department of Women and Children’s Health, Faculty of Life Science and Medicine, King’s College London, London, United Kingdom
aff001; Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, United Kingdom
aff002; Caring Futures Institute, Flinders University, Adelaide, Australia
aff003; Maternity Services, Lewisham and Greenwich NHS Trust, London, United Kingdom
aff004; Department of Midwifery, Kingston University and St. George’s, University of London, United Kingdom
aff005; Department of Public Health, London Borough of Lewisham, London, United Kingdom
aff006
Vyšlo v časopise:
Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation–effectiveness, randomised controlled pilot trial in the UK. PLoS Med 17(10): e32767. doi:10.1371/journal.pmed.1003350
Kategorie:
Research Article
doi:
https://doi.org/10.1371/journal.pmed.1003350
Souhrn
Background
Midwifery continuity of care is the only health system intervention shown to reduce preterm birth (PTB) and improve perinatal survival, but no trial evidence exists for women with identified risk factors for PTB. We aimed to assess feasibility, fidelity, and clinical outcomes of a model of midwifery continuity of care linked with a specialist obstetric clinic for women considered at increased risk for PTB.
Methods and findings
We conducted a hybrid implementation–effectiveness, randomised, controlled, unblinded, parallel-group pilot trial at an inner-city maternity service in London (UK), in which pregnant women identified at increased risk of PTB were randomly assigned (1:1) to either midwifery continuity of antenatal, intrapartum, and postnatal care (Pilot study Of midwifery Practice in Preterm birth Including women’s Experiences [POPPIE] group) or standard care group (maternity care by different midwives working in designated clinical areas). Pregnant women attending for antenatal care at less than 24 weeks' gestation were eligible if they fulfilled one or more of the following criteria: previous cervical surgery, cerclage, premature rupture of membranes, PTB, or late miscarriage; previous short cervix or short cervix this pregnancy; or uterine abnormality and/or current smoker of tobacco. Feasibility outcomes included eligibility, recruitment and attrition rates, and fidelity of the model. The primary outcome was a composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth. We analysed by intention to treat. Between 9 May 2017 and 30 September 2018, 334 women were recruited; 169 women were allocated to the POPPIE group and 165 to the standard group. Mean maternal age was 31 years; 32% of the women were from Black, Asian, and ethnic minority groups; 70% were in employment; and 46% had a university degree. Nearly 70% of women lived in areas of social deprivation. More than a quarter of women had at least one pre-existing medical condition and multiple risk factors for PTB. More than 75% of antenatal and postnatal visits were provided by a named/partner midwife, and a midwife from the POPPIE team was present at 80% of births. The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742). Infants in the POPPIE group were significantly more likely to have skin-to-skin contact after birth, to have it for a longer time, and to breastfeed immediately after birth and at hospital discharge. There were no differences in other secondary outcomes. The number of serious adverse events was similar in both groups and unrelated to the intervention (POPPIE group 6 versus standard group 5). Limitations of this study included the limited power and the nonmasking of group allocation; however, study assignment was masked to the statistician and researchers who analysed the data.
Conclusions
In this study, we found that it is feasible to set up and achieve fidelity of a model of midwifery continuity of care linked with specialist obstetric care for women at increased risk of PTB in an inner-city maternity service in London (UK), but there is no impact on most outcomes for this population group. Larger appropriately powered trials are needed, including in other settings, to evaluate the impact of relational continuity and hypothesised mechanisms of effect based on increased trust and engagement, improved care coordination, and earlier referral on disadvantaged communities, including women with complex social factors and social vulnerability.
Trial registration
We prospectively registered the pilot trial on the UK Clinical Research Network Portfolio Database (ID number: 31951, 24 April 2017). We registered the trial on the International Standard Randomised Controlled Trial Number (ISRCTN) (Number: 37733900, 21 August 2017) and before trial recruitment was completed (30 September 2018) when informed that prospective registration for a pilot trial was also required in a primary clinical trial registry recognised by WHO and the International Committee of Medical Journal Editors (ICMJE). The protocol as registered and published has remained unchanged, and the analysis conforms to the original plan.
Klíčová slova:
Birth – Medical risk factors – Midwives – Neonates – Obstetrics and gynecology – Pregnancy – Preterm birth – Preterm labor
Zdroje
1. WHO: recommended definitions, terminology and format for statistical tables related to the perinatal period and use of a new certificate for cause of perinatal deaths, Modifications recommended by FIGO as amended October 14, 1976. Acta Obstet Gynecol Scand. 1977;56: 247–253. 560099
2. Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, et al. Global, regional, and national causes of under-5 mortality in 2000–15: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet. 2016;388: 3027–3035. doi: 10.1016/S0140-6736(16)31593-8 27839855
3. World Health Organization. Born Too Soon: The Global Action Report On Preterm Birth. Geneva, Switzerland: WHO; 2012.
4. Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, et al. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Global Health. 2019;7: e37–e46. doi: 10.1016/S2214-109X(18)30451-0 30389451
5. Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008;371: 75–84. doi: 10.1016/S0140-6736(08)60074-4 18177778
6. Muglia LJ and Katz M. The enigma of spontaneous preterm birth. N Engl J Med. 2010;362: 529–535. doi: 10.1056/NEJMra0904308 20147718
7. Medley N, Vogel JP, Care A, Alfirevic Z. Interventions during pregnancy to prevent preterm birth: an overview of Cochrane systematic reviews (Review). Cochrane Database Syst Rev. 2018,11: CD012505. doi: 10.1002/14651858.CD012505.pub2 30480756
8. Sandall J, Soltani H, Gates S, Shennan A, Devane D. Midwife-led continuity models versus other models of care for childbearing women. Cochrane Database Syst Rev. 2016;8: CD004667.
9. Renfrew MJ, McFadden A, Bastos MH, Campbell J, Channon AA, Cheung NF, et al. Midwifery and quality care: findings from a new evidence-informed framework for maternal and newborn care. Lancet. 2015;14: 60789–3.
10. NHS England. The NHS Long Term Plan: Maternity and neonatal services [Internet]. 2019 [cited 2019 Oct 3]. Available from: https://www.longtermplan.nhs.uk/online-version/chapter-3-further-progress-on-care-quality-and-outcomes/a-strong-start-in-life-for-children-and-young-people/maternity-and-neonatal-services/
11. Australian Government, Department of Health. Pregnancy care guidelines: Risk of preterm birth [Internet]. 2019 [cited 2019 Nov 6]. Available from: https://www.health.gov.au/resources/pregnancy-care-guidelines/part-d-clinical-assessments/risk-of-preterm-birth
12. World Health Organization. WHO recommendations on antenatal care for a positive pregnancy experience. Geneva, Switzerland: WHO; 2016.
13. World Health Organization. WHO recommendations: intrapartum care for a positive childbirth experience. Geneva, Switzerland: World Health Organization; 2018.
14. Sandall J, Soltani H, Shennan A, Devane D. Implementing midwife-led continuity models of care and what do we still need to find out? [Internet]. 2019 [cited 2019 Sept 3]. Available from: https://www.evidentlycochrane.net/midwife-led-continuity-of-care/
15. Min J, Watson H, Hezelgrave N, Seed P, Shennan A. Ability of a preterm surveillance clinic to triage risk of preterm birth: a prospective cohort study. Ultrasound Obstet Gynecol. 2016;4: 38–42.
16. Fernandez Turienzo C, Sandall J, Peacock J. Models of antenatal care to prevent and reduce preterm birth: a systematic review and meta-analysis. BMJ. 2016;6: e009044.
17. Sandall J, Coxon K, Mackintosh N, Rayment-Jones H, Locock L, Page L. Relationships: the pathway to safe, high-quality maternity care. Report from the Sheila Kitzinger Symposium at Green Templeton College October 2015. Oxford: Green Templeton College; 2016.
18. Kildea S, Simcock G, Liu A, Elgbeili G, Laplante DP, Kahler A, et al. Continuity of midwifery carer moderates the effects of prenatal maternal stress on postnatal maternal wellbeing: the Queensland flood study. Women’s Ment Health. 2018;2: 203–214.
19. Allen J, Kildea S, Stapleton H. How optimal caseload midwifery can modify predictors for preterm birth in young women: Integrated findings from a mixed methods study. Midwifery. 2016;41: 30–38. doi: 10.1016/j.midw.2016.07.012 27498186
20. Public Health England. Public Health Profiles: London Boroughs [Internet]. 2010 [cited 2019 Apr 3]. Available from: https://fingertips.phe.org.uk/profile/health-profiles
21. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler S. Effectiveness-implementation hybrid designs. Medic Car. 2012;3:217–26.
22. Fernandez Turienzo C, Bick D, Briley A, Briley A, Coxon K, Cross P, et al. POPPIE: protocol for a randomised controlled pilot trial of continuity of midwifery care for women at increased risk of preterm birth. Trials. 2019;20: 271. doi: 10.1186/s13063-019-3352-1 31088505
23. National Institute for Health and Care Excellence (NICE). NG109: Urinary tract infection (lower): antimicrobial prescribing. London: National Institute for Health and Care Excellence; 2018.
24. National Institute for Health and Care Excellence (NICE). NG25: Preterm labour and birth. London: National Institute for Health and Care Excellence; 2015.
25. Lewisham and Greenwich NHS Trust. Antenatal Care Guidelines (including Risk Assessment), cervical screening for preterm delivery and management of preterm pre-labour rupture of membranes and preterm labour. London: NHS; 2015.
26. National Institute for Health and Care Excellence (NICE).PH23: Smoking: stopping in pregnancy and after childbirth. 2015, National Institute for Health and Care Excellence: London.
27. Victora CG, Bahl R, Barros AJD, França GV, Horton S, Krasevec J, et al. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016;2: 475–490.
28. NHS England. National Maternity Review. Better Births: Improving Outcomes of Maternity Services in England–A Five Year Forward View for Maternity Care. London: NHS; 2016.
29. World Health Organization. WHO recommendations on interventions to improve preterm birth outcomes. Geneva, Switzerland: WHO; 2015.
30. Kildea S, Gao Y, Hickey S, Kruske S, Nelson C, Blackman R, et al. Reducing preterm birth amongst Aboriginal and Torres Strait Islander babies: a prospective cohort study, Brisbane, Australia. EClinicalMedicine. 2019;12: 43–51.
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