An ethnographic study evaluating emergency obstetric care education and training in a remote, fragile region of Southeast Asia: Study protocol.

AIM: To evaluate emergency obstetric care education and training within a medical assistant training program, being delivered in a remote, fragile region of Southeast Asia. This will aid in the identification of potential areas of enhancement to improve the management of obstetric emergencies. DESIGN: An ethnographic study, adopting a multi-methods approach. METHODS: Emergency obstetric care education and training will be assessed through documentary analysis and interviews (online or face-to-face) with educators and trainers (N ~ 6-7). Student experiences will be explored using in-person focus groups, facilitated by an external trainer involved in delivering the program (N ~ 10-12). A reflective field diary will provide insight into the lived experience of postgraduate students (N ~ 4-5). Data will be collected between May 2022 and May 2023. The full data set will be triangulated and analysed using the READ approach; (1) ready your materials, (2) extract data, (3) analyse data and (4) distil your findings. Institutional ethical approval was obtained from a university in October 2021, and inter-country regional access was gained following adherence to their local ethical requirements. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: The findings from this study may help to inform the future design of the medical assistant training program. It is anticipated that the knowledge gained from this study will enhance the education and training of mid-level health providers at local, national, and international levels. This work intends to contribute to addressing Sustainable Development Goal 3, Target 1 of reducing maternal mortality to 70:100,000 live births in low-income countries. REPORTING METHOD: This protocol adhered to the Standards for Reporting Qualitative Research (SRQR) checklist. PATIENT OR PUBLIC CONTRIBUTION: No formal PPI has been undertaken; however, stakeholders involved in delivering the education and training have been consulted.

Factors associated with antenatal depression in the Kingdom of Jordan during the COVID-19 pandemic.

Fear of infection and measures taken to mitigate infection, such as social distancing, lockdown and isolation can lead to anxiety and depression across the life course, but especially in pregnancy. We set out to identify the prevalence of depression in pregnancy, using Edinburgh Postnatal Depression Scale (EPDS) during national quarantine and to examine women's knowledge, attitude, and practices (KAP) in regard to potential COVID-19-related depression. Following ethical approval, an observational design, with an online questionnaire and snowball sampling was used to recruit 546 pregnant women (231 primi and 315 multiparous) in Jordan via common social media platforms (facebook, WhatsApp). Over one third (36.7%) reported depressive symptoms. There were significantly lower depression scores among pregnant women who exhibited more knowledge about COVID-19 (in high [vs low] knowledge groups, mean EPDS = 10.8 [vs 12.2]; p = 0.007). Depression scores were not significantly associated with attitude nor with practice. This suggests that enhanced knowledge levels may protect pregnant women against depression. Our findings contribute to understanding of the experience of pregnant women in developing countries during the COVID-19 pandemic. Healthcare Professionals should provide health education to all pregnant women and timely services to pregnant women with depressive symptoms. This may lead to the prevention of serious symptoms and reduce negative consequences on the next generation, not only in Jordan, but worldwide.

Using Social Media as a Research Tool for a Bespoke Web-Based Platform for Stakeholders of Children With Congenital Anomalies: Development Study.

BACKGROUND: Limited research evidence exists on the development of web-based platforms for reciprocal communication, coproduction research, and dissemination of information among parents, professionals, and researchers. This paper provides learning and the outcomes of setting up a bespoke web-based platform using social media. OBJECTIVE: This study aims to explore the establishment of a web-based, multicontextual research communication platform for parents and stakeholders of children with congenital anomalies using social media and to identify associated research and ethical and technical challenges. METHODS: The ConnectEpeople e-forum was developed using social media platforms with a stakeholder engagement process. A multilevel approach was implemented for reciprocal engagement between parents of children with congenital anomalies, researchers, health care professionals, and other stakeholders using private and invisible and public Facebook groups, closed Twitter groups, and YouTube. Ethical approval was obtained from Ulster University. RESULTS: Nonprofit organizations (N=128) were invited to engage with an initial response rate of 16.4% (21/128). Of the 105 parents contacted, 32 entered the private and invisible Facebook groups to participate in the coproduction research. Public Facebook page followers rose to 215, a total of 22 posts had an engagement of >10%, and 34 posts had a reach of over 100. Webinars included requested information on childhood milestones and behavior. YouTube coverage included 106 ConnectEpeople videos with 28,708 impressions. Project information was obtained from 35 countries. The highest Facebook activity occurred during the early morning hours. Achievement of these results required dedicated time management, social media expertise, creativity, and sharing knowledge to curate valuable content. CONCLUSIONS: Building and maintaining a multilayered online forum for coproduction and information sharing is challenging. Technical considerations include understanding the functionality and versatility of social media metrics. Social media offers valuable, easily accessible, quantitative, and qualitative data that can drive the reciprocal process of forum development. The identification and integration of the needs of the ConnectEpeople e-forum was a key driver in the dissemination of useful, meaningful, and accessible information. The necessary dedicated administration to respond to requests and posts and collate data required significant time and effort. Participant safety, the development of trust, and the maintenance of confidentiality were major ethical considerations. Discussions on social media platforms enabled parents to support each other and their children. Social media platforms are particularly useful in identifying common family needs related to early childhood development. This research approach was challenging but resulted in valuable outputs requiring further application and testing. This may be of particular importance in response to COVID-19 or future pandemics. Incorporating flexible, adaptable social media strategies into research projects is recommended to develop effective platforms for collaborative and impactful research and dissemination.

Maternal sociodemographic characteristics, early pregnancy behaviours, and livebirth outcomes as congenital heart defects risk factors - Northern Ireland 2010-2014.

BACKGROUND: Congenital Heart Defects (CHD) is the most commonly occurring congenital anomaly in Europe and a major paediatric health care concern. Investigations are needed to enable identification of CHD risk factors as studies have given conflicting results. This study aim was to identify maternal sociodemographic characteristics, behaviours, and birth outcomes as risk factors for CHD. This was a population based, data linkage cohort study using anonymised data from Northern Ireland (NI) covering the period 2010-2014. The study cohort composed of 94,067 live births with an outcome of 1162 cases of CHD using the International Statistical Classification of Diseases and Related Health Problems (ICD)-10 codes and based on the European Surveillance of Congenital Anomalies (EUROCAT) grouping system for CHD. CHD cases were obtained from the HeartSuite database (HSD) at the Royal Belfast Hospital for Sick Children (RBHSC), maternal data were extracted from the Northern Ireland Maternity System (NIMATS), and medication data were extracted from the Enhanced Prescribing Database (EPD). STATA version 14 was used for the statistical analysis in this study, Odds Ratio (OR), 95% Confident intervals (CI), P value, and logistic regression were used in the analysis. Ethical approval was granted from the National Health Service (NHS) Research Ethics Committee. RESULT: In this study, a number of potential risk factors were assessed for statistically significant association with CHD, however only certain risk factors demonstrated a statistically significant association with CHD which included: gestational age at first booking (AOR = 1.21; 95% CI = 1.04-1.41; P < 0.05), family history of CHD or congenital abnormalities and syndromes (AOR = 4.14; 95% CI = 2.47-6.96; P < 0.05), woman's smoking in pregnancy (AOR = 1.22; 95% CI = 1.04-1.43; P < 0.05), preterm birth (AOR = 3.01; 95% CI = 2.44-3.01; P < 0.05), multiple births (AOR = 1.89; 95% CI = 1.58-2.60; P < 0.05), history of abortion (AOR = 1.12; 95% CI = 1.03-1.28; P < 0.05), small for gestational age (SGA) (AOR = 1.44; 95% CI = 1.22-1.78; P < 0.05), and low birth weight (LBW) (AOR = 3.10; 95% CI = 2.22-3.55; P < 0.05). Prescriptions and redemptions of antidiabetic (AOR = 2.68; 95% CI = 1.85-3.98; P < 0.05), antiepileptic (AOR = 1.77; 95% CI = 1.10-2.81; P < 0.05), and dihydrofolate reductase inhibitors (DHFRI) (AOR = 2.13; 95% CI = 1.17-5.85; P < 0.05) in early pregnancy also showed evidence of statistically significant association with CHD. CONCLUSION: The results of this study suggested that there are certain maternal sociodemographic characteristics, behaviours and birth outcomes that are statistically significantly associated with higher risk of CHD. Appropriate prevention policy to target groups with higher risk for CHD may help to reduce CHD prevalence. These results are important for policy makers, obstetricians, cardiologists, paediatricians, midwives and the public.

The impact of COVID-19 on the physical activity and sedentary behaviour levels of pregnant women with gestational diabetes.

BACKGROUND: The aim of this study was to understand how physical activity and sedentary behaviour levels of pregnant women with gestational diabetes in the UK have been affected by COVID-19. METHODS: An online survey exploring physical activity and sedentary behaviour levels of pregnant women with gestational diabetes during COVID-19 was distributed through social media platforms. Women who had been pregnant during the COVID-19 outbreak and had gestational diabetes, were resident in the UK, were 18 years old or over and could understand written English were invited to take part. RESULTS: A total of 724 women accessed the survey, 553 of these met the eligibility criteria and took part in the survey. Sedentary time increased for 79% of the women during the pandemic. Almost half of the women (47%) were meeting the physical activity guidelines pre COVID-19 during their pregnancy, this dropped to 23% during the COVID-19 pandemic. Fear of leaving the house due to COVID-19 was the most commonly reported reason for the decline. Significant associations were found between meeting the physical activity guidelines during COVID-19 and educational attainment, fitness equipment ownership and knowledge of how to exercise safely in pregnancy. CONCLUSIONS AND IMPLICATIONS: These results show the impact of COVID-19 on physical activity and sedentary behaviour levels and highlight the need for targeted public health initiatives as the pandemic continues and for future lockdowns. Women with gestational diabetes need to know how it is safe and beneficial to them to engage in physical activity and ways to do this from their homes if fear of leaving the house due to COVID-19 is a barrier for them. Online physical activity classes provided by certified trainers in physical activity for pregnant women may help them remain active when face-to-face appointments are reduced and limited additional resources are available.

A scoping review protocol: Mapping the range of policy-related evidence influencing maternal health outcomes in a fragile, low-income country.

AIM: The aim of this scoping review is to map the range of policy-related evidence influencing maternal health outcomes and determine the cultural and contextual factors influencing maternal health in Myanmar, a low-income, fragile setting. DESIGN: Eligible studies identified will include maternal health-related policies, policy documents and research. All types of health-related policies aimed at targeting population health and well-being influencing maternal mortality and morbidity will be considered. METHODS: This scoping review has been developed using the Joanna Briggs Institute recommendations. The database search will include MEDLINE, CINAHL, Web of Science, Cochrane Library and the grey literature. Documents published in English and Burmese in the past 10 years will be included. Numerical data will be extracted and summarized in diagrammatic form, and a descriptive format will be used to present narrative accounts. Funding approval was granted by the Economic and Social Research Council in January 2020. This protocol was registered with OSF registries (Open-ended Registration) on 30 March 2021. DISCUSSION: Little is known about which strategies work best as there is less evidence related to health policy and contextual factors in which maternal health care is delivered in fragile, low-income settings. Understanding the context of maternal health is key to the planning and implementation of effective maternal health services designed to address women's needs. IMPACT: This review will map the range of policy-related evidence influencing maternal health outcomes in Myanmar and will underpin future large-scale research in other low-income and fragile settings. The results of this scoping review will provide recommendations for developing and improving practice and education for nurses and midwives working in resource-restricted contexts.

Judgements of health and social care professionals on a child protection referral of an unborn baby: Factorial survey.

BACKGROUND: Midwives and children's services social workers have responsibilities to identify and support pregnant women where there are child protection concerns. Professionals seek to anticipate the risk of harm and initiate interventions to provide support to families. There is little research on how professionals prioritise risk factors and the challenges they face in protecting unborn babies. OBJECTIVE: To measure the impact of identified risk factors regarding child protection referrals of unborn babies on the professional judgements of midwives and children's services social workers. METHODS: A factorial survey design using vignettes with randomised factors within a standardised structure, administered digitally using Qualtrics software. PARTICIPANTS & SETTING: Midwives (n = 250) and children's services social workers (n = 88) from one Health and Social Care Trust in Northern Ireland. RESULTS: One thousand and ninety-six vignettes were completed by 118 participants. Analysis using multiple regression showed that the risk factors together accounted for 44% of the variance in perceived risk of harm and of the variance on perceived need for a referral. The significant Independent Variables (IVs) in order included: drug use, alcohol use, age, antenatal care attendance, mental wellbeing, domestic violence and the pregnant woman's I the childhood experiences. There were no significant differences between midwives and social workers regarding judgements about important risk factors. CONCLUSIONS: This survey provided an ordering of major risk factors influencing decision making to protect an unborn baby from the perspective of experienced social workers and midwives. The study helps professionals in judging the seriousness of risk factors. The interaction effects between risks requires further research.

OptiBIRTH: a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section.

BACKGROUND: Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are low in many countries. METHODS: OptiBIRTH investigated the effects of a woman-centred intervention designed to increase VBAC rates through an unblinded cluster randomised trial in 15 maternity units with VBAC rates < 35% in Germany, Ireland and Italy. Sites were matched in pairs or triplets based on annual birth numbers and VBAC rate, and randomised, 1:1 or 2:1, intervention versus control, following trial registration. The intervention involved evidence-based education of clinicians and women with one previous caesarean section (CS), appointment of opinion leaders, audit/peer review, and joint discussions by women and clinicians. Control sites provided usual care. Primary outcome was annual hospital-level VBAC rates before the trial (2012) versus final year of the trial (2016). Between April 2014 and October 2015, 2002 women were recruited (intervention 1195, control 807), with mode-of-birth data available for 1940 women. RESULTS: The OptiBIRTH intervention was feasible and safe across hospital settings in three countries. There was no statistically significant difference in the change in the proportion of women having a VBAC between intervention sites (25.6% in 2012 to 25.1% in 2016) and control sites (18.3 to 22.3%) (odds ratio adjusted for differences between intervention and control groups (2012) and for homogeneity in VBAC rates at sites in the countries: 0.87, 95% CI: 0.67, 1.14, p = 0.32 based on 5674 women (2012) and 5284 (2016) with outcome data. Among recruited women with birth data, 4/1147 perinatal deaths > 24 weeks gestation occurred in the intervention group (0.34%) and 4/782 in the control group (0.51%), and two uterine ruptures (one per group), a rate of 1:1000. CONCLUSIONS: Changing clinical practice takes time. As elective repeat CS is the most common reason for CS in multiparous women, interventions that are feasible and safe and that have been shown to lead to decreasing repeat CS, should be promoted. Continued research to refine the best way of promoting VBAC is essential. This may best be done using an implementation science approach that can modify evidence-based interventions in response to changing clinical circumstances. TRIAL REGISTRATION: The OptiBIRTH trial was registered on 3/4/2013. Trial registration number ISRCTN10612254.

Cultural perspectives on vaginal birth after previous caesarean section in countries with high and low rates - A hermeneutic study.

BACKGROUND: Caesarean section (CS) rates are increasing worldwide, an increase that is multifactorial and not well understood. There is considerable variation in the rates of vaginal birth after previous Caesarean section (VBAC). Cultural differences could be one explanation of the varying rates. OBJECTIVE: To interpret cultural perspectives on VBAC. METHODS: A hermeneutic approach for analysing findings from four published qualitative studies that were part of the OptiBIRTH study, focusing on clinicians and women's views of important factors for improving the rate of VBAC. 115 clinicians and 73 women participated in individual interviews and focus group interviews in countries with low rates (Germany, Italy and Ireland) and countries with high rates (Sweden, Finland and the Netherlands), in the original studies. RESULTS: Three themes demonstrated how the culture differs between the high and low VBAC rate countries; from being an obvious first alternative to an issue dependent on many factors; from something included in the ordinary care to something special; and from obstetrician making the final decision to a choice by the woman. The fourth theme, preparing for a new birth by early follow-up and leaving the last birth behind, reflects coherence between the cultures. DISCUSSION: The findings deepen our understanding of why the VBAC rates vary across countries and healthcare settings, and can be used for improving the care for women. CONCLUSION: In order to improve VBAC rates both maternity care settings and individual professionals need to reflect on their VBAC culture, and make make changes to develop a 'pro-VBAC culture'.

Exploring Research Priorities of Parents Who Have Children With Down Syndrome, Cleft Lip With or Without Cleft Palate, Congenital Heart Defects, or Spina Bifida Using ConnectEpeople: A Social Media Coproduction Research Study.

BACKGROUND: Using social media for research purposes is novel and challenging in terms of recruitment, participant knowledge about the research process, and ethical issues. This paper provides insight into the recruitment of European parents of children with specific congenital anomalies to engage in coproduction research by using social media. Secret Facebook groups, providing optimal security, were set up for newly recruited research-aware parents (RAPs) to communicate privately and confidentially with each other and for the research team to generate questions and to interpret findings. OBJECTIVE: This study aimed to use social media for the recruitment and engagement of parents in research and to determine the research priorities of parents who have children with Down syndrome, cleft lip with or without cleft palate, congenital heart defects, and spina bifida. METHODS: The design was exploratory and descriptive with 3 phases. Phase 1 included the recruitment of RAPs and generation of research questions important to them; phase 2 was a Web-based survey, designed using Qualtrics software, and phase 3 included analysis and ranking of the top 10 research questions using an adapted James Lind Alliance approach. Simple descriptive statistics were used for analysis, and ethical approval was obtained from the Ethics Filter Committee of the Institute of Nursing and Health Research, Ulster University. RESULTS: The recruitment of 32 RAPs was a sensitive process, varying in the time taken to consent (mean 51 days). However, parents valued the screening approach using the State-Trait Anxiety Inventory as a measure to ensure their well-being (mean 32.5). In phase 1, RAPs generated 98 research questions. In phase 2, 251 respondents accessed the Web-based survey, 248 consented, and 80 completed the survey, giving a completeness rate of 32.3% (80/248). Most parents used social media (74/80, 92%). Social media, online forums, and meeting in person were ranked the most preferable methods for communication with support groups networks and charities. Most respondents stated that they had a good understanding of research reports (71/80, 89%) and statistics (68/80, 85%) and could differentiate among the different types of research methodologies (62/80, 78%). Phase 3 demonstrated consensus among RAPs and survey respondents, with a need to know the facts about their child's condition, future health, and psychosocial and educational outcomes for children with similar issues. CONCLUSIONS: Social media is a valuable facilitator in the coproduction of research between parents and researchers. From a theoretical perspective, ocularcentrism can be an applicable frame of reference for understanding how people favor visual contact.

A systematic review investigating if genetic or epigenetic markers are associated with postnatal depression.

BACKGROUND: Postnatal depression (PND) is common, affects the health of the mother, the development of the infant and places a large financial burden on services. Genetic and epigenetic biomarkers for PND could potentially improve the accuracy of current antenatal screening approaches. The aim of this systematic review is to report on the evidence for an association between genetic or epigenetic factors and postnatal depression. METHOD: A systematic search of five databases (Medline, EMBASE, PILOT, PsychINFO and SCOPUS) was carried out using the following (MeSh) terms and keywords: postpartum, depression, postnatal depression, genetics, genetic polymorphisms and epigenetics. Inclusion criteria were applied and quality of studies was assessed using guidelines from the HuGE Review Handbook (Little and Higgins, 2006). RESULTS: Following removal of duplicate articles, 543 remained; of these 37 met the inclusion criteria. Positive associations have been reported between PND and polymorphisms in the HMNC1, COMT, MAOT, PRKCB, ESR1, SLC6A4 genes in the presence of stressful life events, the BDNF gene when the postnatal period occurs during autumn and winter months and the OXT and OXTR genes in the presence of childhood adversity experienced by the mother. Epigenetic interactions with genotype, estrogen, and childhood adversity were identified that are predictive of PND. LIMITATIONS: The number of studies investigating some of the markers was small and grey literature was not included. CONCLUSION: This review highlights the importance of examining the interaction between epigenetic, genetic, hormonal and environmental factors in order to fully understand the risk factors for PND and to improve the accuracy of current antenatal and early postnatal screening procedures. Women susceptible to PND appear to have heightened epigenetic sensitivity to the physiological changes of childbirth or to environmental factors conferred by genotype.

The preconception care experiences of women with epilepsy on sodium valproate.

PURPOSE: To understand the preconception experiences of women with epilepsy who have been taking the teratogenic drug valproate. METHODS: Seven women were recruited, three from a preconception clinic and four from an antenatal clinic in a region of the UK. All had taken valproate preconceptionally. Three preconception clinic encounters were observed and audio-recorded. Interviews with all women were analysed using Interpretative Phenomenological Analysis (IPA). RESULTS: Women experienced a "trajectory of balance". Women moved from "maintaining balance" by using valproate to control seizures, to a "shattering of harmony" at the prospect of changing medication and as a result of the physical and mental effects of changing medication, to "restoring balance" which could involve "a new self" due to dramatic changes. Women balanced their health needs with those of their baby, and took responsibility for medication decision-making. They found it difficult to see "who is looking after me" in the healthcare system, either to access preconception care, or to support them through the stress of changing medication. Their journey ended with coming to terms with a variety of experiences: choosing not to have a baby due to unsuccessful change from valproate, recognising that a child from a previous pregnancy had been harmed by valproate or that the current pregnancy might be at risk, or successful medication change in preparation for pregnancy. CONCLUSION: A clear and adequately funded preconception care pathway is needed from epilepsy diagnosis, including support for stress. Understanding what influences maternalisation may help understand uptake of preconception care.

Reflexology: A randomised controlled trial investigating the effects on beta-endorphin, cortisol and pregnancy related stress.

Reflexology is used for various pregnancy related complaints. A three-armed, pilot randomised controlled trial was conducted to test changes in physiological and biochemical stress parameters. Ninety primiparous volunteers experiencing low back and/or pelvic girdle pain (LBPGP) were recruited to receive either six reflexology or footbath treatments or usual care. Primary outcome data included pain intensity and frequency measured on a visual analog scale (VAS), and salivary beta-endorphin and cortisol levels. 61 (68%) women completed the intervention. A clinically important reduction of 1.63 cm occurred for VAS pain frequency following reflexology. Beta-endorphin levels increased by 8.8% and 10.10% in the footbath and usual care groups respectively and decreased by 15.18% for the reflexology group. Cortisol increased by 31.78% for footbath participants, 31.42% in usual care and 18.82% in the reflexology group. Reflexology during pregnancy may help reduce LBPGP, and associated stress. However, antenatal reflexology is under researched and requires further investigation.

The use of complementary and alternative medicine (CAM) for pregnancy related low back and/ or pelvic girdle pain: An online survey.

Low back and pelvic girdle pain (LBPGP) is a common complaint among pregnant women, which increases throughout pregnancy and women use various complementary and alternative medicine (CAM) therapies to manage their pain. Using an online survey, CAM treatments used by pregnant women in the UK and their perceptions of these therapies to relieve LBPGP were investigated. 191 women completed the survey and 70% experienced LBPGP lasting more than one week. Over half of women who sought treatment from a GP or physiotherapist were dissatisfied. 25% of participants used CAM during pregnancy, the most popular being aromatherapy (21%), acupuncture (21%), and reflexology (15%). 81% of women used CAM to manage their LBPGP and 85% found it useful for pregnancy symptoms. Women experience high levels of pain during pregnancy with limited treatment options. Research into effective CAM treatments for LBPGP is required to allow women to make informed decisions regarding treatment options.

A descriptive systematic review of salivary therapeutic drug monitoring in neonates and infants.

AIMS: Saliva, as a matrix, offers many benefits over blood in therapeutic drug monitoring (TDM), in particular for infantile TDM. However, the accuracy of salivary TDM in infants remains an area of debate. This review explored the accuracy, applicability and advantages of using saliva TDM in infants and neonates. METHODS: Databases were searched up to and including September 2016. Studies were included based on PICO as follows: P: infants and neonates being treated with any medication, I: salivary TDM vs. C: traditional methods and O: accuracy, advantages/disadvantages and applicability to practice. Compounds were assessed by their physicochemical and pharmacokinetic properties, as well as published quantitative saliva monitoring data. RESULTS: Twenty-four studies and their respective 13 compounds were investigated. Four neutral and two acidic compounds, oxcarbazepine, primidone, fluconazole, busulfan, theophylline and phenytoin displayed excellent/very good correlation between blood plasma and saliva. Lamotrigine was the only basic compound to show excellent correlation with morphine exhibiting no correlation between saliva and blood plasma. Any compound with an acid dissociation constant (pKa) within physiological range (pH 6-8) gave a more varied response. CONCLUSION: There is significant potential for infantile saliva testing and in particular for neutral and weakly acidic compounds. Of the properties investigated, pKa was the most influential with both logP and protein binding having little effect on this correlation. To conclude, any compound with a pKa within physiological range (pH 6-8) should be considered with extra care, with the extraction and analysis method examined and optimized on a case-by-case basis.

Process evaluation for OptiBIRTH, a randomised controlled trial of a complex intervention designed to increase rates of vaginal birth after caesarean section.

BACKGROUND: Complex interventions encompassing several interconnecting and interacting components can be challenging to evaluate. Examining the underlying trial processes while an intervention is being tested can assist in explaining why an intervention was effective (or not). This paper describes a process evaluation of a pan-European cluster randomised controlled trial, OptiBIRTH (undertaken in Ireland, Italy and Germany), that successfully used both quantitative and qualitative methods to enhance understanding of the underlying trial mechanisms and their effect on the trial outcome. METHODS: We carried out a mixed methods process evaluation. Quantitative and qualitative data were collected from observation of the implementation of the intervention in practice to determine whether it was delivered according to the original protocol. Data were examined to assess the delivery of the various components of the intervention and the receipt of the intervention by key stakeholders (pregnant women, midwives, obstetricians). Using ethnography, an exploration of perceived experiences from a range of recipients was conducted to understand the perspective of both those delivering and those receiving the intervention. RESULTS: Engagement by stakeholders with the different components of the intervention varied from minimal intensity of women's engagement with antenatal classes, to moderate intensity of engagement with online resources, to high intensity of clinicians' exposure to the education sessions provided. The ethnography determined that, although the overall culture in the intervention site did not change, smaller, more individual cultural changes were observed. The fidelity of the delivery of the intervention scored average quality marks of 80% and above on repeat assessments. CONCLUSION: Nesting a process evaluation within the trial enabled the observation of the mode of action of the intervention in its practice context and ensured that the intervention was delivered with a good level of consistency. Implementation problems were identified as they arose and were addressed accordingly. When dealing with a complex intervention, collecting and analysing both quantitative and qualitative data, as we did, can greatly enhance the process evaluation. TRIAL REGISTRATION: Current Controlled Trials Register, ISRCTN10612254 . Registered on 3 April 2013.

Mode of birth and postnatal health-related quality of life after one previous cesarean in three European countries.

BACKGROUND: How a woman gives birth can affect her health-related quality of life (HRQoL). This study explored HRQoL at 3 months postpartum in women with a history of one previous cesarean in three European countries. METHODS: A prospective longitudinal survey, embedded within a cluster randomized trial in three countries, exploring women's postnatal HRQoL up to 3 months postpartum. The Short-Form Six-Dimensions (SF-6D) was used to measure HRQoL, and multivariate analyses were used to examine the relationship with mode of birth. RESULTS: Complete data were available from 880 women. Women with a spontaneous vaginal birth had the highest HRQoL scores, whereas women with an emergency repeat cesarean (P = .01) had the lowest. Postnatal readmission of the mother (P = .03), having public health insurance (P = .04), and a low antenatal HRQoL score (P < .01) contributes to poorer HRQoL scores. More specifically, women with a spontaneous vaginal birth had significantly higher HRQoL scores on the vitality dimension compared with women with an emergency repeat cesarean (P = .04). CONCLUSIONS: In women with low-risk factors, repeat cesareans result in a poorer HRQoL compared with vaginal birth. When there are no contraindications for vaginal birth, women with a history of one previous cesarean should be encouraged to give birth vaginally rather than have an elective repeat cesarean.

An assessment of pregnant women's knowledge and use of the Internet for medication safety information and purchase.

AIM: The aim of this study was to assess pregnant women's Internet searching activity about medication safety, knowledge and perceptions of medication risk and willingness to take prescribed and non-prescribed medication or make online medication purchases. BACKGROUND: Online medication advice for pregnant women is complex. The quality and veracity of this data is increasingly important as more midwives report women are bringing retrieved online information to clinical appointments. Pregnant women's use of the Internet for seeking medication advice and purchasing medications has not yet been fully investigated. DESIGN: Online survey conducted from January - March 2013. FINDINGS: Of the 284 respondents, 39% were taking a medication when they became pregnant and 76% had searched the Internet for medication safety information. Analgesics were the most commonly searched category (41%). Health service sites were the most common online source and regarded as the most helpful and trusted. Regardless of age and education level, 90% of women agreed that if trying to become pregnant they would reconsider taking any medications because of the potential risk to their unborn baby. Forty-six percent of women with higher levels of education consider buying medication online as safe, a greater proportion than those of lower education. Five percent of women reported buying medication online. CONCLUSION: The lack of specific recommendations for medication use during pregnancy is challenging for healthcare staff and pregnant women who need robust evidence to make informed treatment decisions. The Internet is a recognized, commonly accessed, source of medication information for pregnant women.

A pilot randomised controlled trial exploring the effects of antenatal reflexology on labour outcomes.

OBJECTIVE: to investigate the effects of antenatal reflexology on labour outcomes. DESIGN: secondary analysis of a pilot three-armed randomised controlled trial conducted between July 2012 and September 2013. SETTING: a large UK inner city hospital maternity department. PARTICIPANTS: ninety primiparous women with a singleton pregnancy experiencing low back and / or pelvic girdle pain. INTERVENTIONS: six weekly 30-minute reflexology treatments compared to sham (footbath) treatments or usual antenatal care only. MEASUREMENTS: labour outcome data including labour onset, duration of the second stage of labour, epidural and Entonox usage, and mode of delivery. Participant feedback was collected prior to each treatment. FINDINGS: labour outcomes were collected for 61 women (95.3%) who completed the study. The second stage of labour duration data, available for 42 women (62.5%) who had vaginal births, showed a mean reduction of 44minutes in the reflexology group (73.56minutes; SD= 53.78) compared to the usual care (117.92minutes; SD=56.15) (p<0.05) and footbath groups (117.4minutes; SD=68.54) (p=0.08). No adverse effects were reported. KEY CONCLUSIONS: in this trial antenatal reflexology reduced labour duration for primiparous women who had experienced low back and/ or pelvic girdle pain during their pregnancy, compared with usual care and footbaths. IMPLICATIONS FOR PRACTICE: reflexology is suitable for use during pregnancy, is safe and enjoyable and may reduce labour duration. Midwives may wish to recommend reflexology to promote normal childbirth and facilitate women centred care. TRIAL REGISTRATION: this trial was listed with the International Standard Randomised Controlled Trial Number Register (ISRCTN26607527).