The effectiveness of decision aids for pregnancy related decision-making in women with pre-pregnancy morbidity; systematic review and meta-analysis.

INTRODUCTION: Women with pre-existing morbidity arising from medical conditions or previous caesarean section are at higher risk of adverse pregnancy outcomes compared to women without such morbidity. Women often face complex pregnancy-related decision-making that may be characterized by conflicting maternal and perinatal priorities. The aim of this systematic review and meta-analysis was to assess randomised controlled trials of decision aids to evaluate whether they are effective at reducing decisional conflict scores and to evaluate what type of decision aids are most effective for women with pre-existing morbidity in pregnancy. METHODS: We searched Medline (via Ovid), Embase (via Ovid), CINAHL (via EBSCO) from the earliest entries until September 2021. We selected randomised controlled trials comparing patient decision aids for women with pre-existing morbidity with usual clinical practice or a control intervention. Study characteristics and Jadad risk of bias was recorded. Meta-analysis by pre-existing morbidity type was performed using Stata 17 and the data was presented with a Forest Plot. Random effects models were used to calculate summary estimates if there was substantial clinical or statistical heterogeneity and post mean DCS scores were described in a sensitivity analysis and presented as a line graph, to improve clinical interpretation of results.. A narrative synthesis of the selected studies evaluated what type of decision aid works and for in what circumstances. RESULTS: Ten randomised controlled trials, which reported data from 4028 women, were included. Patient decision aids were evaluated in women with pre-existing morbidity who were undertaking pregnancy-related decision-making. Patient decision aids reduced decisional conflict scale scores by an additional - 3.7, 95% Confidence Interval - 5.9% to - 1.6%) compared to the control group. Women with pre-existing medical conditions were more conflicted at baseline and had greater reductions in decisional conflict scale score (mean difference vs. control group: - 6.6%; 95% CI - 9.8% to - 3.3%), in contrast to those with previous caesarean section (mean difference - 2.4%; 95% CI - 4.8% to - 0.1%). There was limited evidence on the effect of decision aids on health outcomes. Decision aids reduced unwanted variation in decision-making support across maternity settings. CONCLUSION: Patient decision aids are effective tools to support personalised care planning and informed decision-making in women with pre-existing morbidity. Women with pre-existing medical morbidity were more conflicted at baseline and were more likely to benefit from decision aids. Adoption of aids in this population may lead to improve adherence and health outcomes, warranting further research

Ten women's decision-making experiences in threatened preterm labour: Qualitative findings from the EQUIPTT trial.

BACKGROUND: Clinical triage of women in threatened preterm labour (TPTL) could be improved through utilising the QUiPP App, as symptoms alone are poor predictors of early delivery. As most women in TPTL ultimately deliver at term, they must weigh this likelihood with their own personal considerations, and responsibilities. The importance of personal considerations was highlighted by the 2015 Montgomery ruling, and the significance of shared decision-making. AIMS: Through qualitative interviews, the primary aim was to explore women's decision-making experiences in TPTL through onset of symptoms, triage, clinical assessment, and discharge. METHODS: Qualitative interviews were undertaken as part of the EQUIPTT study (REC: 17/LO/1802) using a semi-structured interview schedule. Descriptive labels of the coding scheme were applied to the raw transcript data. This coding scheme was then increasingly refined into key themes and allowed parallels to be made within and between cases. RESULTS: Ten ethnically diverse women who presented at six different London hospitals sites in TPTL were interviewed. Three final themes emerged from the data incorporating 10 sub-themes, 'Seeking help', 'Being "assessed" vs making clinical decisions together', and 'End result.' CONCLUSION: Women described their busy lives and the need to juggle their commitments. Participants drew comparisons between their TPTL symptoms and 'period pain,' contrasting to typical medical terminology. Shared decision-making and the clinician-patient relationship could be improved through clinicians utilizing terminology women understand and relate to. Women used language that highlighted the clinician-patient power balance. While not fully involved in shared decision-making, women were overall satisfied with their care

Clinicians' experiences of using and implementing a medical mobile phone app (QUiPP V2) designed to predict the risk of preterm birth and aid clinical decision making.

BACKGROUND: As the vast majority of women who present in threatened preterm labour (TPTL) will not deliver early, clinicians need to balance the risks of over-medicalising the majority of women, against the potential risk of preterm delivery for those discharged home. The QUiPP app is a free, validated app which can support clinical decision-making as it produces individualised risks of delivery within relevant timeframes. Recent evidence has highlighted that clinicians would welcome a decision-support tool that accurately predicts preterm birth. METHODS: Qualitative interviews were undertaken as part of the EQUIPTT study (The Evaluation of the QUiPP app for Triage and Transfer) (REC: 17/LO/1802) which aimed to evaluate the impact of the QUiPP app on management of TPTL. Individual semi-structured telephone interviews were used to explore clinicians' (obstetricians' and midwives') experiences of using the QUiPP app and how it was implemented at their hospital sites. Thematic analysis was chosen to explore the meaning of the data, through a framework approach. RESULTS: Nineteen participants from 10 hospital sites in England took part. Data analysis revealed three overarching themes which were: 'experience of using the app', 'how QUiPP risk changes practice' and 'successfully adopting QUiPP: context is everything'. With these final themes we appeared to have achieved our aim of exploring the clinicians' experiences of using and implementing the QUiPP app. CONCLUSION: This study explored different clinician's experiences of implementing the app. The organizational and cultural context at different sites appeared to have a large impact on how well the QUiPP app was implemented. Future work needs to be undertaken to understand how best to embed the intervention within different settings. This will inform scale up of QUiPP app use across the UK and ensure that clinicians have access to this free, easy-to-use tool which can positively aid clinical decision making when caring for women in TPTL. CLINICAL TRIAL REGISTRY AND REGISTRATION NUMBER: ISRCTN 17846337, registered 08th January 2018, https://doi.org/10.1186/ISRCTN17846337

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.

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)

Effect of the CRADLE vital signs alert device intervention on referrals for obstetric haemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomised control trial.

BACKGROUND: Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occur in low and middle income countries. The majority of deaths and adverse events are associated with delays in identifying compromise and escalating care. Management of severely compromised pregnant women may require transfer to tertiary centres for specialised treatment, therefore early recognition is vital for efficient management. The CRADLE vital signs alert device accurately measures blood pressure and heart rate, calculates the shock index (heart rate divided by systolic blood pressure) and alerts the user to compromise through a traffic light system reflecting previously validated shock index thresholds. METHODS: This is a planned secondary analysis of data from the CRADLE-3 trial from ten clusters across Africa, India and Haiti where the device and training package were randomly introduced. Referral data were prospectively collected for a 4-week period before, and a 4-week period 3 months after implementation. Referrals from primary or secondary care facilities to higher level care for any cause were recorded. The denominator was the number of women seen for maternity care in these facilities. RESULTS: Between April 1 2016 and Nov 30th, 2017 536,223 women attended maternity care facilities. Overall, 3.7% (n = 2784/74,828) of women seen in peripheral maternity facilities were referred to higher level care in the control period compared to 4.4% (n = 3212/73,371) in the intervention period (OR 0.89; 0.39-2.05) (data for nine sites that were able to collect denominator). Of these 0.29% (n = 212) pre-intervention and 0.16% (n = 120) post-intervention were referred to higher-level facilities for maternal haemorrhage. Although overall referrals did not significantly reduce there was a significant reduction in referrals for obstetric haemorrhage (OR 0.56 (0.39-0.65) following introduction of the device with homogeneity (i-squared 26.1) between sites. There was no increase in any bleeding-related morbidity (maternal death or emergency hysterectomy). CONCLUSIONS: Referrals for obstetric haemorrhage reduced following implementation of the CRADLE Vital Signs Alert Device, occurring without an increase in maternal death or emergency hysterectomy. This demonstrates the potential benefit of shock index in management pathways for obstetric haemorrhage and targeting limited resources in low- middle- income settings. TRIAL REGISTRATION: This study is registered with the ISRCTN registry, number ISRCTN41244132 (02/02/2016)

Labetalol Versus Nifedipine as Antihypertensive Treatment for Chronic Hypertension in Pregnancy: A Randomized Controlled Trial

Data from randomized controlled trials to guide antihypertensive agent choice for chronic hypertension in pregnancy are limited; this study aimed to compare labetalol and nifedipine, additionally assessing the impact of ethnicity on treatment efficacy. Pregnant women with chronic hypertension (12+0-27+6 weeks' gestation) were enrolled at 4 UK centers (August 2014 to October 2015). Open-label first-line antihypertensive treatment was randomly assigned: labetalol- (200-1800 mg/d) or nifedipine-modified release (20-80 mg/d). Analysis included 112 women (98%) who completed the study (labetalol n=55, nifedipine n=57). Maximum blood pressure after randomization was 161/101 mm Hg with labetalol versus 163/105 mm Hg with nifedipine (mean difference systolic: 1.2 mm Hg [-4.9 to 7.2 mm Hg], diastolic: 3.3 mm Hg [-0.6 to 7.3 mm Hg]). Mean blood pressure was 134/84 mm Hg with labetalol and 134/85 mm Hg with nifedipine (mean difference systolic: 0.3 mm Hg [-2.8 to 3.4 mm Hg], and diastolic: -1.9 mm Hg [-4.1 to 0.3 mm Hg]). Nifedipine use was associated with a 7.4-mm Hg reduction (-14.4 to -0.4 mm Hg) in central aortic pressure, measured by pulse wave analysis. No difference in treatment effect was observed in black women (n=63), but a mean 4 mm Hg reduction (-6.6 to -0.8 mm Hg; P=0.015) in brachial diastolic blood pressure was observed with labetalol compared with nifedipine in non-black women (n=49). Labetalol and nifedipine control mean blood pressure to target in pregnant women with chronic hypertension. This study provides support for a larger definitive trial scrutinizing the benefits and side effects of first-line antihypertensive treatment. CLINICAL TRIAL REGISTRATION: URL: https://www.isrctn.com. Unique identifier: ISRCTN40973936

Placental Growth Factor (PlGF) in Women with Suspected Pre-Eclampsia Prior to 35 Weeks' Gestation: A Budget Impact Analysis

OBJECTIVES: To model the resource implications of placental growth factor (PlGF) testing in women with suspected pre-eclampsia prior to 35 weeks’ gestation as part of a management algorithm, compared with current practice. METHODS: Data on resource use from 132 women with suspected pre-eclampsia prior to 35 weeks’ gestation, enrolled in a prospective observational cohort study evaluating PlGF measurement within antenatal assessment units within two UK consultant-led maternity units was extracted by case note review. A decision analytic model was developed using these data to establish the budget impact of managing women with suspected pre-eclampsia for two weeks from the date of PlGF testing, using a clinical management algorithm and reference cost tariffs. The main outcome measures of resource use (numbers of outpatient appointments, ultrasound investigations and hospital admissions) were correlated to final diagnosis and used to calculate comparative management regimes. RESULTS: The mean cost saving associated with the PlGF test (in the PlGF plus management arm) was £35,087 (95% CI -£33,181 to -£36,992) per 1,000 women. This equated to a saving of £582 (95% CI -552 to -£613) per woman tested. In 94% of iterations, PlGF testing was associated with cost saving compared to current practice. CONCLUSIONS: This analysis suggests PlGF used as part of a clinical management algorithm in women presenting with suspected pre-eclampsia prior to 35 weeks’ gestation could provide cost savings by reducing unnecessary resource use. Introduction of PlGF testing could be used to direct appropriate resource allocation and overall would be cost saving

Placental growth factor testing for suspected pre‐eclampsia: a cost‐effectiveness analysis

Objective To calculate the cost‐effectiveness of implementing PlGF testing alongside a clinical management algorithm in maternity services in the UK, compared with current standard care. Design Cost‐effectiveness analysis. Setting Eleven maternity units participating in the PARROT stepped‐wedge cluster‐randomised controlled trial. Population Women presenting with suspected pre‐eclampsia between 20+0 and 36+6 weeks’ gestation. Methods Monte Carlo simulation utilising resource use data and maternal adverse outcomes. Main outcome measures Cost per maternal adverse outcome prevented. Results Clinical care with PlGF testing costs less than current standard practice and resulted in fewer maternal adverse outcomes. There is a total cost‐saving of UK£149 per patient tested, when including the cost of the test. This represents a potential cost‐saving of UK£2,891,196 each year across the NHS in England. Conclusions Clinical care with PlGF testing is associated with the potential for cost‐savings per participant tested when compared with current practice via a reduction in outpatient attendances, and improves maternal outcomes. This economic analysis supports a role for implementation of PlGF testing in antenatal services for the assessment of women with suspected pre‐eclampsia. Tweetable abstract Placental growth factor testing for suspected pre‐eclampsia is cost‐saving and improves maternal outcomes

Can birth outcome inequality be reduced using targeted caseload midwifery in a deprived diverse inner city population? A retrospective cohort study, London, UK.

Objectives(1) To report maternal and newborn outcomes of pregnant women in areas of social deprivation in inner city London. (2) To compare the effect of caseload midwifery with standard care on maternal and newborn outcomes in this cohort of women.DesignRetrospective observational cohort study.SettingFour council wards (electoral districts) in inner city London, where over 90% of residents are in the two most deprived quintiles of the English Index of Multiple Deprivation (IMD) (2019) and the population is ethnically diverse.ParticipantsAll women booked for antenatal care under Guys and St Thomas' National Health Service Foundation Trust after 11 July 2018 (when the Lambeth Early Action Partnership (LEAP*) caseload midwifery team was implemented) until data collection 18 June 2020. This included 523 pregnancies in the LEAP area, of which 230 were allocated to caseload midwifery, and 8430 pregnancies from other areas.Main outcome measuresTo explore if targeted caseload midwifery (known to reduce preterm birth) will improve important measurable outcomes (preterm birth, mode of birth and newborn outcomes).ResultsThere was a significant reduction in preterm birth rate in women allocated to caseload midwifery, when compared with those who received traditional midwifery care (5.1% vs 11.2%; risk ratio: 0.41; p=0.02; 95% CI 0.18 to 0.86; number needed to treat: 11.9). Caesarean section births were significantly reduced in women allocated to caseload midwifery care, when compared with traditional midwifery care (24.3% vs 38.0%; risk ratio: 0.64: p=0.01; 95% CI 0.47 to 0.90; number needed to treat: 7.4) including emergency caesarean deliveries (15.2% vs 22.5%; risk ratio: 0.59; p=0.03; 95% CI 0.38 to 0.94; number needed to treat: 10) without increase in neonatal unit admission or stillbirth.ConclusionThis study shows that a model of caseload midwifery care implemented in an inner city deprived community improves outcome by significantly reducing preterm birth and birth by caesarean section when compared with traditional care. This data trend suggests that when applied to targeted groups (women in higher IMD quintile and women of diverse ethnicity) that the impact of intervention is greater

Prediction of uncomplicated pregnancies in obese women: a prospective multicentre study.

BACKGROUND: All obese pregnant women are considered at equal high risk with respect to complications in pregnancy and birth, and are commonly managed through resource-intensive care pathways. However, the identification of maternal characteristics associated with normal pregnancy outcomes could assist in the management of these pregnancies. The present study aims to identify the factors associated with uncomplicated pregnancy and birth in obese women, and to assess their predictive performance. METHODS: Data form obese women (BMI ≥ 30 kg/m2) with singleton pregnancies included in the UPBEAT trial were used in this analysis. Multivariable logistic regression was used to identify sociodemographic, clinical and biochemical factors at 15+0 to 18+6 weeks' gestation associated with uncomplicated pregnancy and birth, defined as delivery of a term live-born infant without antenatal or labour complications. Predictive performance was assessed using area under the receiver operating characteristic curve (AUROC). Internal validation and calibration were also performed. Women were divided into fifths of risk and pregnancy outcomes were compared between groups. Sensitivity, specificity, and positive and negative predictive values were calculated using the upper fifth as the positive screening group. RESULTS: Amongst 1409 participants (BMI 36.4, SD 4.8 kg/m2), the prevalence of uncomplicated pregnancy and birth was 36% (505/1409). Multiparity and increased plasma adiponectin, maternal age, systolic blood pressure and HbA1c were independently associated with uncomplicated pregnancy and birth. These factors achieved an AUROC of 0.72 (0.68-0.76) and the model was well calibrated. Prevalence of gestational diabetes, preeclampsia and other hypertensive disorders, preterm birth, and postpartum haemorrhage decreased whereas spontaneous vaginal delivery increased across the fifths of increasing predicted risk of uncomplicated pregnancy and birth. Sensitivity, specificity, and positive and negative predictive values were 38%, 89%, 63% and 74%, respectively. A simpler model including clinical factors only (no biomarkers) achieved an AUROC of 0.68 (0.65-0.71), with sensitivity, specificity, and positive and negative predictive values of 31%, 86%, 56% and 69%, respectively. CONCLUSION: Clinical factors and biomarkers can be used to help stratify pregnancy and delivery risk amongst obese pregnant women. Further studies are needed to explore alternative pathways of care for obese women demonstrating different risk profiles for uncomplicated pregnancy and birth