POPPIE: protocol for a randomised controlled pilot trial of continuity of midwifery care for women at increased risk of preterm birth

Turienzo, C. Fernandez; Bick, Debra; Bollard, Mary; Brigante, Lia; Briley, Annette; Coxon, Kirstie; Cross, Pauline; Mehta, Minesh P.; Melaugh, Alexandra; Moulla, J.; Seed, Paul; Shennan, Andrew; Singh, Claire; Tribe, Rachel M.; Sandall, Jane

doi:10.1186/s13063-019-3352-1

Cited by 9 publications

(16 citation statements)

References 29 publications

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“…This study is reported as per the CONsolidated Standards of Reporting Trials (CONSORT) ( S1 CONSORT Checklist). There were no substantial changes to the published study design [ 22 ] after commencement of the trial.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2020

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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

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Section: Methodsmentioning

confidence: 99%

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

et al. 2020

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“…The main POPPIE trial paper is described in detail elsewhere [19], but in brief, this study used a two-arm hybrid implementation-effectiveness, randomised, controlled pilot trial within an inner-city teaching hospital in the UK between, to compare midwifery continuity of care (POPPIE group) with standard maternity care (standard group) for women identified at increased risk of PTB. Pregnant women attending for antenatal care at less than 24 weeks' gestation were eligible if they were considered at risk of preterm birth (e.g.…”

Section: Study Design and Participantsmentioning

confidence: 99%

Experiences of maternity care among women at increased risk of preterm birth receiving midwifery continuity of care compared to women receiving standard care: Results from the POPPIE pilot trial

et al. 2021

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Background Midwifery continuity of care models for women at low and mixed risk of complications have been shown to improve women’s experiences of care. However, there is limited research on care experiences among women at increased risk of preterm birth. We aimed to explore the experiences of care among women with risk factors for preterm birth participating in a pilot trial (POPPIE) of a midwifery continuity of care model which included a specialist obstetric clinic. Methods A total of 334 pregnant women identified at increased risk of preterm birth were randomly allocated to either midwifery continuity of care (POPPIE group) or standard maternity care. Women in both groups were followed up at six-to-eight weeks postpartum and were invited to complete a postnatal survey either online or by post. An equal status exploratory sequential mixed method design was chosen to collect and analyse the quantitative postnatal survey data and qualitative interviews data. The postnatal survey included measures of social support, trust, perceptions of safety, quality of care, control during childbirth, bonding and quality of life. Categorical data were analysed with chi-squared tests and continuous data were analysed with t-tests and/or Mann-Whitney U test to measure differences in measures scores among groups. The qualitative interview data were subjected to a thematic framework analysis. Data triangulation brought quantitative and qualitative data together at the interpretation stage. Findings A total of 166 women completed the survey and 30 women were interviewed (90 and 16 in POPPIE group; 76 and 14 in standard group). We found survey respondents in the POPPIE group, compared to respondents in the standard group, were significantly more likely to report greater trust in midwives (Mann-Whitney U, p<0.0001), greater perceptions of safety during the antenatal care (t-test, p = 0.0138), have a particular midwife to contact when they needed during their pregnancy (t-test, p<0.0001) and the postnatal period (chi-squared, p<0.0001). They reported increased involvement in decisions regarding antenatal, intrapartum and postnatal care (t-test, p = 0.002; p = 0.008; p = 0.006 respectively); and greater postnatal support and advice about: feeding the baby (chi-squared, p<0.0001), handling, settling and looking after the baby (chi-squared, p<0.0001), baby’s health and progress (chi-squared, p = 0.039), their own health and recovery (chi-squared, p = 0.006) and who to contact about any emotional changes (chi-squared, p = 0.005). There were no significant differences between groups in the reporting of perceptions of safety during birth and the postnatal period, concerns raised during labour and birth taken seriously, being left alone during childbirth at a time of worries, control during labour, bonding, social support, and physical and mental health related quality of life after birth. Results from qualitative interviews provided insight and depth into many of these findings, with women in the POPPIE group reporting more positive experiences of bonding towards their babies and more positive physical health postnatally. Conclusions Compared with standard maternity care, women at increased risk of PTB who received midwifery continuity of care were more likely to report increased perceptions of trust, safety and quality of care. Trial registration ISRCTN (Number: 37733900); UK CRN (ID: 31951).

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“…Middle‐range theories are helpful to conceptualize complex reality so that explanations of findings become possible and generalizable 14 . This conceptualization can also inform the analysis of ongoing studies evaluating continuity models of care for women at increased risk of PTB 19 …”

Section: Methodsmentioning

confidence: 99%

A realist review to explore how midwifery continuity of care may influence preterm birth in pregnant women

Turienzo

Rayment-Jones

Roe

et al. 2021

Birth

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Background Midwifery continuity of care models are the only health system intervention associated with both a reduction in preterm birth (PTB) and an improvement in perinatal survival; however, questions remain about the mechanisms by which such positive outcomes are achieved. We aimed to uncover theories of change by which we can postulate how and why continuity of midwifery care models might affect PTB. Methods We followed Pawson's guidance for conducting a realist review and performed a comprehensive search to identify existing literature exploring the impact of continuity models on PTB in all pregnant women. A realist methodology was used to uncover the context (C), mechanisms (M), and outcomes (O) and to develop a group of CMO configurations to illuminate middle‐range theories. Results Eleven papers were included from a wide variety of settings in the United Kingdom, Australia, and the United States. The majority of study participants had low socioeconomic status or social risk factors and received diverse models of midwifery continuity of care. Three themes—woman‐midwife partnership, maternity pathways and processes, and system resources—encompassed ten CMO configurations. Building relationships, trust, confidence, and advocacy resulted in women feeling safer, less stressed, and more secure and respected, and encouraged them to access and engage in antenatal care with more opportunities for early prevention and diagnosis of complications, which facilitated effective management when compliance to guidelines was ensured. Organizational infrastructure, innovative partnerships, and robust community systems are crucial to overcome barriers, address women's complex needs, ensure quality of care, and reduce PTB risk. Conclusions Pregnant women living in different contexts in the United Kingdom, Australia, and the United States at low and mixed risk of complications and with low socioeconomic status or social risk factors experienced continuity models in similar ways, and similar underlying mechanisms may have influenced PTB outcomes. Further research is required to understand how continuity models may influence behavioral change, physiological stress levels, ethnic disparities in PTB and care coordination, and navigation of health services.

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POPPIE: protocol for a randomised controlled pilot trial of continuity of midwifery care for women at increased risk of preterm birth

Cited by 9 publications

References 29 publications

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 versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation–effectiveness, randomised controlled pilot trial in the UK

Experiences of maternity care among women at increased risk of preterm birth receiving midwifery continuity of care compared to women receiving standard care: Results from the POPPIE pilot trial

A realist review to explore how midwifery continuity of care may influence preterm birth in pregnant women

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