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

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...

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Bibliographic Details
Published in:PLoS medicine 2020-10, Vol.17 (10), p.e1003350-e1003350
Main Authors: Fernandez Turienzo, Cristina, Bick, Debra, Briley, Annette L, Bollard, Mary, Coxon, Kirstie, Cross, Pauline, Silverio, Sergio A, Singh, Claire, Seed, Paul T, Tribe, Rachel M, Shennan, Andrew H, Sandall, Jane
Format: Article
Language:English
Subjects:
Adult
Biology and Life Sciences
Biopsy
Birth
Care and treatment
Catchment areas
Cervix
Cesarean Section
Continuity of care
Continuity of Patient Care - organization & administration
Continuum of care
Ethnic Groups
Female
Gestation
Gestational Age
Health services
Humans
Infant
Infant, Newborn
Infants
Intervention
Maternal Age
Maternal child nursing
Maternal health services
Maternal Health Services - trends
Medicine and Health Sciences
Methods
Midwifery
Midwifery - trends
Minority Groups
Obstetric Labor, Premature
Obstetrics
Parturition
People and Places
Pilot Projects
Postnatal Care - methods
Pregnancy
Pregnant women
Premature birth
Premature Birth - prevention & control
Prenatal care
Prenatal Care - methods
Prevention
Professional ethics
Prospective Studies
Random Allocation
Risk factors
Surgery
Tobacco
Ultrasonic imaging
United Kingdom - epidemiology
Uterus
Womens health
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Summary: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. 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 sk
ISSN:1549-1676
1549-1277
1549-1676
DOI:10.1371/journal.pmed.1003350