Using mHealth to reduce disparities in Black maternal health: Perspectives from Black rural postpartum mothers.

BACKGROUND: Racial disparities are evident in maternal morbidity and mortality rates globally. Black women are more likely to die from pregnancy and childbirth than any other race or ethnicity. This leaves one of the largest gaps in women's health to date. OBJECTIVES: mHealth interventions that connect with women soon after discharge may assist in individualizing and formalizing support for mothers in the early postpartum period. To aid in developing an mHealth application, Black postpartum mothers' perspectives were examined. DESIGN: Utilizing the Sojourner Syndrome Framework and Maternal Mortality & Morbidity Measurement Framework, group interview discussion guides were developed to examine the facilitators and barriers of postpartum transitional care for rural Black women living in the United States to inform the development of a mobile health application. METHODS: In this study, seven group interviews were held with Black mothers, their support persons, and healthcare providers in rural Georgia to aid in the development of the Prevent Maternal Mortality Using Mobile Technology (PM3) mobile health (mHealth) application. Group interviews included questions about (1) post-birth experiences; (2) specific needs (e.g. clinical, social support, social services, etc.) in the postpartum period; (3) perspectives on current hospital discharge processes and information; (4) lived experiences with racism, classism, and/or gender discrimination; and (5) desired features and characteristics for the mobile app development. RESULTS: Fourteen out of the 78 screened participants were eligible and completed the group interview. Major discussion themes included: accessibility to healthcare and resources due to rurality, issues surrounding race and perceived racism, mental and emotional well-being in the postpartum period, and perspectives on the PM3 mobile application. CONCLUSION: Participants emphasized the challenges that postpartum Black women face in relation to accessibility, racism and discrimination, and mental health. The women favored a culturally relevant mHealth tool and highlighted the need to tailor the application to address disparities.

The role of clinic-based breastfeeding peer counseling on breastfeeding rates among low-income patients.

BACKGROUND: Despite the benefits of breastfeeding (BF), rates remain lower than public health targets, particularly among low-income Black populations. Community-based breastfeeding peer counselor (BPC) programs have been shown to increase BF. We sought to examine whether implementation of a BPC program in an obstetric clinical setting serving low-income patients was associated with improved BF initiation and exclusivity. METHODS: This is a quasi-experimental time series study of pregnant and postpartum patients receiving care before and after implementation of a BPC program in a teaching hospital affiliated prenatal clinic. The role of the BPC staff included BF classes, prenatal counseling and postnatal support, including in-hospital assistance and phone triage after discharge. Records were reviewed at each of 3 time points: immediately before the hire of the BPC staff (2008), 1-year post-implementation (2009), and 5 years post-implementation (2014). The primary outcomes were rates of breastfeeding initiation and exclusivity prior to hospital discharge, secondary outcomes included whether infants received all or mostly breastmilk during inpatient admission and by 6 weeks post-delivery. Bivariable and multivariable analyses were utilized as appropriate. RESULTS: Of 302 patients included, 52.3% identified as non-Hispanic Black and 99% had Medicaid-funded prenatal care. While there was no improvement in rates of BF initiation, exclusive BF during the postpartum hospitalization improved during the 3 distinct time points examined, increasing from 13.7% in 2008 to 32% in 2014 (2009 aOR 2.48, 95%CI 1.13-5.43; 2014 aOR 1.82, 95%CI 1.24-2.65). This finding was driven by improved exclusive BF for patients who identified as Black (9.4% in 2008, 22.9% in 2009, and 37.9% in 2014, p = 0.01). CONCLUSION: Inpatient BF exclusivity significantly increased with the tenure of a BPC program in a low-income clinical setting. These findings demonstrate that a BPC program can be a particularly effective method to address BF disparities among low-income Black populations.

Reproductive health care for incarcerated women in the prenatal and postpartum periods.

In 1976, the Supreme Court mandated that incarcerated individuals have a constitutional right to receive medical care; however, there are no mandatory standards so access to and quality of reproductive health care for incarcerated pregnant women varies widely across facilities. Without federal or state standards, there is variability in the type of prenatal care pregnant women receive, their birthing experience, how long they are able to stay with their infant after birth, and whether they are permitted to breastfeed or express milk. In this column, I review policies related to reproductive health care in carceral settings, the gaps in data collection and research, programs to support the needs of incarcerated pregnant women, and recommendations from professional organizations on reproductive health care for incarcerated women in the prenatal and postpartum periods.

Expanding comprehensive pregnancy care for Emergency Medicaid recipients: a cost-effectiveness analysis.

BACKGROUND: Emergency Medicaid is a restricted benefits program for individuals who have low-income status and who are immigrants. OBJECTIVE: This study aimed to compare the cost-effectiveness of 2 strategies of pregnancy coverage for Emergency Medicaid recipients: the federal minimum of covering the delivery only vs extended coverage to 60 days after delivery. STUDY DESIGN: A decision analytical Markov model was developed to evaluate the outcomes and costs of these policies, and the results in a theoretical cohort of 100,000 postpartum Emergency Medicaid recipients were considered. The payor perspective was adopted. Health outcomes and cost-effectiveness over a 1- and 3-year time horizon were investigated. All probabilities, utilities, and costs were obtained from the literature. Our primary outcome was the incremental cost-effectiveness ratio of the competing strategies. RESULTS: Extending Emergency Medicaid to 60 days after delivery was determined to be a cost-saving strategy. Providing postpartum and contraceptive care resulted in 33,900 additional people receiving effective contraception in the first year and prevented 7290 additional unintended pregnancies. Over 1 year, it resulted in a gain of 1566 quality-adjusted life year at a cost of $10,903 per quality-adjusted life year. By 3 years of policy change, greater improvements were observed in all outcomes, and the expansion of Emergency Medicaid became cost saving and the dominant strategy. CONCLUSION: The inclusion of postpartum care and contraception for immigrant women who have low-income status resulted in lower costs and improved health outcomes.

Protocol for an intervention development and pilot implementation evaluation study of an e-health solution to improve newborn care quality and survival in two low-resource settings, Malawi and Zimbabwe: Neotree.

INTRODUCTION: Every year 2.4 million deaths occur worldwide in babies younger than 28 days. Approximately 70% of these deaths occur in low-resource settings because of failure to implement evidence-based interventions. Digital health technologies may offer an implementation solution. Since 2014, we have worked in Bangladesh, Malawi, Zimbabwe and the UK to develop and pilot Neotree: an android app with accompanying data visualisation, linkage and export. Its low-cost hardware and state-of-the-art software are used to improve bedside postnatal care and to provide insights into population health trends, to impact wider policy and practice. METHODS AND ANALYSIS: This is a mixed methods (1) intervention codevelopment and optimisation and (2) pilot implementation evaluation (including economic evaluation) study. Neotree will be implemented in two hospitals in Zimbabwe, and one in Malawi. Over the 2-year study period clinical and demographic newborn data will be collected via Neotree, in addition to behavioural science informed qualitative and quantitative implementation evaluation and measures of cost, newborn care quality and usability. Neotree clinical decision support algorithms will be optimised according to best available evidence and clinical validation studies. ETHICS AND DISSEMINATION: This is a Wellcome Trust funded project (215742_Z_19_Z). Research ethics approvals have been obtained: Malawi College of Medicine Research and Ethics Committee (P.01/20/2909; P.02/19/2613); UCL (17123/001, 6681/001, 5019/004); Medical Research Council Zimbabwe (MRCZ/A/2570), BRTI and JREC institutional review boards (AP155/2020; JREC/327/19), Sally Mugabe Hospital Ethics Committee (071119/64; 250418/48). Results will be disseminated via academic publications and public and policy engagement activities. In this study, the care for an estimated 15 000 babies across three sites will be impacted. TRIAL REGISTRATION NUMBER: NCT0512707; Pre-results.

Changing the home visiting research paradigm: models' perspectives on behavioral pathways and intervention techniques to promote good birth outcomes.

BACKGROUND: The US is scaling up evidence-based home visiting to promote health equity in expectant families and families with young children. Persistently small average effects for full models argue for a new research paradigm to understand what interventions within models work best, for which families, in which contexts, why, and how. Historically, the complexity and proprietary nature of most evidence-based models have been barriers to such research. To address this, stakeholders are building the Precision Paradigm, a common framework and language to define and test interventions and their mediators and moderators. This observational study used portions of an early version of the Precision Paradigm to describe models' intended behavioral pathways to good birth outcomes and their stance on home visitors' use of specific intervention technique categories to promote families' progress along intended pathways. METHODS: Five evidence-based home visiting models participated. Model representatives independently completed three structured surveys focused on 41 potential behavioral pathways to good birth outcomes, and 23 behavior change technique categories. Survey data were used to describe and compare models' intended behavioral pathways, explicit endorsement of behavior change technique categories, expectations for home visitors' relative emphasis in using endorsed technique categories, and consistency in endorsing technique categories across intended pathways. RESULTS: Models differed substantially in nearly all respects: their intended pathways to good birth outcomes (range 16-41); the number of technique categories they endorsed in any intended pathway (range 12-23); the mean number of technique categories they endorsed per intended pathway (range 1.5-20.0); and their consistency in endorsing technique categories across intended pathways (22%-100% consistency). Models were similar in rating nearly all behavior change technique categories as at least compatible with their model, even if not explicitly endorsed. CONCLUSIONS: Models successfully used components of the Precision Paradigm to define and differentiate their intended behavioral pathways and their expectations for home visitors' use of specific technique categories to promote family progress on intended pathways. Use of the Precision Paradigm can accelerate innovative cross-model research to describe current models and to learn which interventions within home visiting work best for which families, in which contexts, why and how.

The Risk of Readmission after Early Postpartum Discharge during the COVID-19 Pandemic.

OBJECTIVE: To determine whether early postpartum discharge during the coronavirus disease 2019 (COVID-19) pandemic was associated with a change in the odds of maternal postpartum readmissions. STUDY DESIGN: This is a retrospective analysis of uncomplicated postpartum low-risk women in seven obstetrical units within a large New York health system. We compared the rate of postpartum readmissions within 6 weeks of delivery between two groups: low-risk women who had early postpartum discharge as part of our protocol during the COVID-19 pandemic (April 1-June 15, 2020) and similar low-risk patients with routine postpartum discharge from the same study centers 1 year prior. Statistical analysis included the use of Wilcoxon's rank-sum and chi-squared tests, Nelson-Aalen cumulative hazard curves, and multivariate logistic regression. RESULTS: Of the 8,206 patients included, 4,038 (49.2%) were patients who had early postpartum discharge during the COVID-19 pandemic and 4,168 (50.8%) were patients with routine postpartum discharge prior to the COVID-19 pandemic. The rates of postpartum readmissions after vaginal delivery (1.0 vs. 0.9%; adjusted odds ratio [OR]: 0.75, 95% confidence interval [CI]: 0.39-1.45) and cesarean delivery (1.5 vs. 1.9%; adjusted OR: 0.65, 95% CI: 0.29-1.45) were similar between the two groups. Demographic risk factors for postpartum readmission included Medicaid insurance and obesity. CONCLUSION: Early postpartum discharge during the COVID-19 pandemic was associated with no change in the odds of maternal postpartum readmissions after low-risk vaginal or cesarean deliveries. Early postpartum discharge for low-risk patients to shorten hospital length of stay should be considered in the face of public health crises. KEY POINTS: · Early postpartum discharge was not associated with an increase in odds of hospital readmissions after vaginal delivery.. · Early postpartum discharge was not associated with an increase in odds of hospital readmissions after cesarean delivery.. · Early postpartum discharge for low-risk patients should be considered during a public health crisis..

Facilitating Perinatal Access to Resources and Support (PeARS): a feasibility study with external pilot of a novel intervention.

BACKGROUND: Up to 50% of women in areas of high socio-economic deprivation are at risk of developing depressive symptoms in pregnancy. Feeling well supported, can facilitate good mental health perinatally. A brief, innovative intervention to facilitate access to support and resources was developed and tested. This included one antenatal and one postnatal session, each with three evidence-based components: i) support from a non-professional peer to enable a woman to identify her needs; ii) information about local community services and signposting; and iii) development of a personalised If-Then plan to access that support. The aims were to evaluate the intervention and research methods for feasibility and acceptability for perinatal women, maternity care providers and peers, and provide preliminary effectiveness indications. METHODS: Pregnant women living in an area of high deprivation were recruited from community-based antenatal clinics and randomised to intervention or control condition (a booklet about local resources). Outcome measures included women's use of community services by 34 + weeks gestation and 6 months postnatally; mental health and wellbeing measures, and plan implementation. Interviews and focus groups were conducted with women participants, providers, and peers. Data were analysed using framework analysis. Recruitment and retention of peers and participants, intervention fidelity, and acceptability of outcome measures were recorded. RESULTS: Peer facilitators could be recruited, trained, retained and provide the intervention with fidelity. One hundred twenty six women were recruited and randomised, 85% lived in the 1% most deprived UK areas. Recruitment constituted 39% of those eligible, improving to 54% after midwifery liaison. Sixty five percent were retained at 6 months postnatally. Women welcomed the intervention, and found it helpful to plan access to community services. Providers strongly supported the intervention philosophy and integrated this easily into services. The study was not powered to detect significant group differences but there were positive trends in community service use, particularly postnatally. No differences were evident in mental health and wellbeing. CONCLUSIONS: This intervention was well received and easily integrated into existing services. Women living in highly deprived areas could be recruited, randomised and retained. Measures were acceptable. Peer facilitators were successfully trained and retained. Full effectiveness studies are warranted.

Patient perceptions of the benefits and barriers of virtual postnatal care: a qualitative study.

OBJECTIVE: The objective of this study is to understand the perceptions of new mothers using virtual care via video conferencing to gain insight into the benefits and barriers of virtual care for obstetric patients. METHODS: Semi-structured interviews were conducted with 15 patients attending the Kingston Health Sciences Centre. The interviews were 20-25 min in length and recorded through an audio recorder. Thematic analysis was conducted in order to derive the major themes explored in this study. RESULTS: New mothers must often adopt new routines to balance their needs and their child's needs. These routines could impact compliance and motivation to attend follow-up care. In our study, participants expressed high satisfaction with virtual care, emphasizing benefits related to comfort, convenience, communication, socioeconomic factors, and the ease of technology use. Participants also perceived that they could receive emotional support and build trust with their health care providers despite the remote nature of their care. Due to its ease of use and increased accessibility, we argue that virtual care shows promise to facilitate long-term compliance to care in obstetric patients. CONCLUSIONS: Virtual care is a useful modality that could improve compliance to obstetric care. Further research and clinical endeavours should examine how social factors and determinants intersect to determine how they underpin patient perceptions of virtual and in-person care.

The experiences of postnatal women and healthcare professionals of a brief weight management intervention embedded within the national child immunisation programme.

BACKGROUND: After childbirth, most women do not lose the extra weight gained during pregnancy. This is important because postnatal weight retention contributes to the development of obesity in later life. Research shows that postnatal women living with overweight would prefer to weigh less, are interested in implementing weight loss strategies, and would like support. Without evidence for the benefit of weight management interventions during pregnancy, postnatal interventions are increasingly important. Research has focused on intensive weight loss programmes, which cannot be offered to all postnatal women. Instead, we investigated the feasibility of a brief intervention delivered to postnatal women at child immunisation appointments. This qualitative study explored the views of women who received the intervention and healthcare professionals who delivered it. METHODS: The intervention was delivered within the context of the national child immunisation programme. The intervention group were offered brief support encouraging self-management of weight when attending general practices to have their child immunised at two, three and four months of age. The intervention involved motivation and support from practice nurses to encourage women to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme. Nurses provided external accountability for weight loss. Women were asked to weigh themselves weekly and record this on a weight record card. Nested within this trial, semi-structured interviews explored the experiences of postnatal women who received the intervention and nurses who delivered it. RESULTS: The intervention was generally acceptable to participants and child immunisation appointments considered a suitable intervention setting. Nurses were hesitant to discuss maternal weight, viewing the postnatal period as a vulnerable time. Whilst some caveats to implementation were discussed by nurses, they felt the intervention was easy to deliver and would motivate postnatal women to lose weight. CONCLUSIONS: Participants were keen to lose weight after childbirth. Overall, they reported that the intervention was acceptable, convenient, and, appreciated support to lose weight after childbirth. Although nurses, expressed concerns about raising the topic of weight in the early postnatal period, they felt the intervention was easy to deliver and would help to motivate women to lose weight.

Bridging the postpartum gap: best practices for training of obstetrical patient navigators.

The postpartum period represents a critical window of opportunity to improve maternal short- and long-term health, including optimizing postpartum recovery, providing effective contraception, caring for mood disorders, managing weight, supporting lactation, initiating preventive care, and promoting cardiometabolic health. However, inadequate postpartum care, especially for individuals facing social and structural barriers, is common in the United States and contributes to suboptimal health outcomes with lasting consequences. Patient navigation is a patient-centered intervention that uses trained personnel to identify financial, cultural, logistical, and educational obstacles to effective healthcare and to mitigate these barriers to facilitate comprehensive and timely access to needed health services. Given the emerging evidence suggesting that patient navigation may be a promising method to improve health among postpartum individuals, our team developed a postpartum patient navigator training guide to be used in the Navigating New Motherhood 2 and other obstetrical navigation programs. Navigating New Motherhood 2 is a randomized trial exploring whether patient navigation by a trained, lay postpartum navigator for individuals with a low income can improve health and patient-reported outcomes during and after the postpartum period. Hiring and training patient navigators without health professional degrees are integral components of initiating a navigation program. However, patient navigator training is highly variable, and no guideline regarding key elements in such a training program exists for obstetrics specifically. Thus, this paper aimed to describe the core principles, content, and rationale for each element in a comprehensive postpartum patient navigator training program. Training should be centered around the following 6 core elements: (1) principles of patient navigation; (2) knowledge of pregnancy and postpartum care; (3) health education and health promotion principles; (4) cultural sensitivity and health equity; (5) care coordination and community resources; and (6) electronic medical record systems. These core elements can serve as a basis for the development of adaptable curricula for several institutions and contexts. In addition, we offer recommendations for the implementation of a navigator training program. A curriculum with built-in flexibility to meet community and institutional needs may promote the effective and sustainable use of patient navigation in the postpartum context.

Adapting breastfeeding support in areas of socio-economic deprivation: a case study approach.

BACKGROUND: There are inequalities in breastfeeding initiation and continuation rates, whereby socio-economically disadvantaged mothers are least likely to breastfeed. Breastfeeding peer support (BPS) interventions are recommended as a solution, and in the UK non-profit organisations are commissioned to deliver BPS services in areas of socio-economic deprivation. BPS interventions have a mixed evidence base, offering limited knowledge about the interaction between context and intervention and how this affects women's experiences. METHODS: This interpretive study used a case study methodology to explore how and why two BPS services developed their services in socio-economically deprived contexts. Methods aimed to generate holistic understanding of BPS service development. Data collected across both cases comprised; observation (n = 1), and semi-structured interviews with: mothers who had (n = 10) and had not (n = 9) engaged with the BPS services, peer supporters (PSs) (n = 9), community health professionals (n = 5), infant feeding co-ordinators (n = 2), non-profit organisation managers (n = 3), and public health commissioners (n = 2). Inductive grounded theory analytic techniques of open coding and constant comparisons, followed by cross case comparisons, were used to analyse the data. RESULTS: The over-arching theme - 'the transcending influence of society' - offers insights into the underlying context and drivers impacting service development. It reflects how funding and data sharing arrangements determined service operation and the peer's access to women. Four underpinning themes explain how: peer supporters were resourceful in adapting their services ('adapting and modifying the support'); BPS organisations worked to enable women's access to supportive breastfeeding environments, but did not necessarily focus service development on the needs of women living in areas of deprivation ('supporting women's journeys to access'); the BPS-professional connections for supporting access and how BPS could result in more supportive community environments ('embedding within healthcare practice'); and how management practices precluded meaningful use of data to provide context led service development ('ways of using knowledge'). CONCLUSIONS: Findings suggest that while PSs are commissioned to focus on those most in need, there is limited discussion, collection, or use of knowledge about women's lives to develop needs-led service delivery. The key recommendation is the development of a social ecological tool to facilitate the use and application of contextual knowledge.

Patient and Provider Perceptions of a Patient Navigation Program to Improve Postpartum Care Among Publicly Insured Women.

OBJECTIVE: This study was aimed to assess patient and provider perceptions of a postpartum patient navigation program. STUDY DESIGN: This was a mixed-method assessment of a postpartum patient navigation program. Navigating New Motherhood (NNM) participants completed a follow-up survey including the Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) scale and an open-ended question. PSN-I scores were analyzed descriptively. Eighteen provider stakeholders underwent in-depth interviews to gauge program satisfaction, perceived outcomes, and ideas for improvement. Qualitative data were analyzed by the constant comparative method. RESULTS: In this population of low-income, minority women, participants (n = 166) were highly satisfied with NNM. The median PSN-I score was 45 out of 45 (interquartile range [IQR]: 43-45), where a higher score corresponds to higher satisfaction. Patient feedback was also highly positive, though a small number desired more navigator support. Provider stakeholders offered consistently positive program feedback, expressing satisfaction with NNM execution and outcomes. Provider stakeholders noted that navigators avoided inhibiting clinic workflow and eased clinic administrative burden. They perceived NNM improved multiple clinical and satisfaction outcomes. All provider stakeholders believed that NNM should be sustained long-term; suggestions for improvement were offered. CONCLUSION: A postpartum patient navigation program can perceivably improve patient satisfaction, clinical care, and clinic workflow without burden to clinic providers.

Racial/Ethnic Differences in Prenatal and Postnatal Counseling About Maternal and Infant Health-Promoting Practices Among Teen Mothers.

STUDY OBJECTIVE: Disparities in perinatal counseling among all pregnant women exist, yet teen data are lacking. We evaluated racial/ethnic differences in (1) prenatal and (2) postnatal counseling of teen mothers. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cross-sectional study included Pregnancy Risk Assessment Monitoring System data from 2012-2016 and included mothers 19 years of age and younger. INTERVENTIONS AND MAIN OUTCOME MEASURES: Counseling measures included tobacco, alcohol and illicit drugs, weight gain, HIV testing, influenza vaccination, breastfeeding, infant safe sleep, postpartum depression, and contraception. Bivariate associations of maternal/infant characteristics and counseling were estimated using χ2 tests. Multivariable logistic regression was used to assess the independent relationship between race/ethnicity and counseling. RESULTS: A weighted sample of 544,930 teen mothers was analyzed. Compared with non-Hispanic white (NHW) teens, non-Hispanic black teens were more likely to receive counseling on tobacco (adjusted odds ratio [aOR], 1.4; 95% confidence interval [CI], 1.10-1.77), alcohol (aOR, 1.77; 95% CI, 1.28-2.46), illicit drugs (aOR, 1.79; 95% CI, 1.33-2.41), and HIV testing (aOR, 1.62; 95% CI, 1.26-2.09). Compared with NHW teens, Hispanic teens were less likely to receive tobacco counseling (aOR, 0.78; 95% CI, 0.64-0.97) and more likely to receive influenza vaccine counseling (aOR, 1.44; 95% CI, 1.18-1.76). No difference was found in receipt of postnatal counseling. CONCLUSION: Racial/ethnic differences in receipt of perinatal counseling exist, with non-Hispanic black teens being more likely to receive counseling on substance use and HIV testing and Hispanic teens being more likely to receive influenza vaccine recommendations compared with NHW teens. Ongoing investigation is needed to understand drivers of these differences.

＜Editors' Choice＞ Factors influencing utilization of postnatal care visits in Afghanistan.

The World Health Organization (WHO) defines the postnatal period as the first six weeks (42 days) after delivery and recommends four postnatal care (PNC) visits for women giving birth to a child to enable early detection and treatment of complications. However, a low utilization of PNC visits by Afghan women has contributed to a relatively high maternal mortality in Afghanistan. This study aimed to identify factors influencing the utilization of PNC visits among Afghan women by sampling nationally representative data from Afghanistan Demographic and Health Survey (AfDHS), 2015. The logistic model was used to measure the adjusted odds of utilizing PNC services among women, with a 95% confidence interval (95% CI) and a p-value of <0.05 for statistical significance. The study found that the utilization of PNC visits in Afghanistan is low; among 8,581 women (44%) who utilized PNC visits and 10,924 women (56%) who didn't, the women's age, place of residence, parity, education, occupation, number of antenatal care (ANC) visits, place of delivery, exposure to public media, the woman's role in decision making and needing a permission to seek healthcare were found to be associated with the level of utilization of PNC visits. Based on the study results, health promotion interventions are recommended to increase the utilization of PNC visits.

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.

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.

Pharmaco-vigilance of oral MethylErgometrine prescriptions for delayed and secondary postpartum haemorrhage.

Objectives The objectives of this study were to quantify the prescription of oral methergin tablets in a busy Women's Hospital, assess the stated indications for such prescription and highlight the issues and safety profile of Methergin use especially in the postpartum patient. Methods Review of prescription data for oral Methergin and the corresponding annual figures on primary and secondary postpartum hemorrhage. Results Over a period of 5 years, oral Methergin prescriptions for delayed and secondary postpartum hemorrhage constituted less than 1% of the overall prescription in Obstetrics and Gynaecology, which ranged between 1214 and 2085 per year. The numbers were too few to ascertain any relationship with both types of postpartum hemorrhage. Although stated on the relevant Patient Information leaflet, no local or regional guideline on its use exist. Conclusions Specific and random trend monitoring of medications for continuing safety profile, risk benefit issues, or unapproved indication, may help in identifying, preventing and mitigating any medication safety matters. Clinical pharmacists in collaboration with physicians are well placed in conducting such pharmacovigilance activities to improve medication safety.

Blood pressure postpartum (BP2) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.

OBJECTIVES: Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP2) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters. STUDY DESIGN: Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months. MAIN OUTCOME MEASURES: Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change. SECONDARY OUTCOMES: maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change. CONCLUSIONS: BP2 will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.

Individual breastfeeding support with contingent incentives for low-income mothers in the USA: the 'BOOST (Breastfeeding Onset & Onward with Support Tools)' randomised controlled trial protocol.

INTRODUCTION: National breastfeeding rates have improved in recent years, however, disparities exist by socioeconomic and psychosocial factors. Suboptimal breastfeeding overburdens the society by increasing healthcare costs. Existing breastfeeding supports including education and peer support have not been sufficient in sustaining breastfeeding rates especially among low-income women. The preliminary outcomes of contingent incentives for breastfeeding in addition to existing support show promising effects in sustaining breastfeeding among mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC). METHODS AND ANALYSIS: This trial uses a parallel randomised controlled trial. This trial is conducted at two sites in separate states in the USA. Mothers who were enrolled in WIC and initiated breastfeeding are eligible. Participants (n=168) are randomised into one of the two study groups: (1) standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding. All participants receive standard breastfeeding services from WIC, home-based individual support and assessments. Participants in SC receive financial compensation based on the number of completed monthly home visits, paid in a lump sum at the end of the 6-month intervention period. Participants in SC +BFI receive an escalating magnitude of financial incentives contingent on observed breastfeeding, paid monthly during the intervention period, as well as bonus incentives for selecting full breastfeeding food packages at WIC. The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC. The primary outcome is the rate of any breastfeeding over 12 months. Randomisation is completed in an automated electronic system. Staff conducting home visits for support and assessments are blinded to study groups. ETHICS AND DISSEMINATION: The Advarra Institutional Review Board has approved the study protocol (Pro00033168). Findings will be disseminated to our participants, scientific communities, public health officials and any other interested community members. TRIAL REGISTRATION NUMBER: NCT03964454.