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1.
Matern Child Health J ; 28(2): 253-266, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38341837

ABSTRACT

INTRODUCTION: The number of incarcerated pregnant women is increasing globally. With many having complex health and social backgrounds, incarceration provides opportunities for health interventions, including the chance to have their nutritional needs met. Despite the additional nutritional requirements of pregnancy being well documented, how these are being met within the correctional setting is currently poorly understood. METHODS: A scoping review of the literature was conducted to identify the literature published between January 2010 and April 2023 related to the provision of nutrition for pregnant women in the international prison systems. Sixteen papers met the criteria for inclusion in the review. The relevant key findings were charted and thematically analysed. RESULTS: Two themes were identified: 'the inconsistent reality of food provision' and 'choice, autonomy and food'. There is a clear disparity in the way in which diet is prioritised and provided to pregnant incarcerated women across several countries. DISCUSSION: The findings highlight the need for a consistent approach to diet on a macro, global level to ensure the health of women and their infants in context.


Subject(s)
Pregnant Women , Prisoners , Infant , Female , Humans , Pregnancy , Prisons , Food , Diet
2.
Addict Sci Clin Pract ; 19(1): 2, 2024 Jan 05.
Article in English | MEDLINE | ID: mdl-38183129

ABSTRACT

BACKGROUND: Alcohol, tobacco and illicit drug use during pregnancy can cause significant harm to women and their developing fetuses. Despite recommendations for abstinence during pregnancy, some women continue to use, making screening for substance use during antenatal clinic attendances an important strategy for reducing risk. This study aims to improve the rates of screening and intervention for substance use among pregnant women, including appropriate referral for those who may be substance-dependent. The protocol outlined here focuses on a multi-stage implementation study. METHODS: This study will occur in four phases. Phase 1 will identify a baseline rate of screening and subsequent care at the antenatal clinics of two, South Australian hospital-based maternity services, through a retrospective case note audit. Rates of self-reported substance use identified in the case notes will also be compared against representative data from Adelaide Primary Health Network to establish rates of over or underreporting. Phase 2 will involve an online Training Needs Analysis of midwifery staff working at those services, to assess their knowledge, attitudes, beliefs, and commitment to the care of women who use substances during pregnancy. Phase 3 will involve a training package for all midwifery staff at those services, focused on routine screening for substance use, and how to provide appropriate care. Outcome measures from phase 2 will be reassessed during phase 3 and any changes since training will be evaluated. Phase 4 will then repeat phase 1 to compare the changes in rates of both screening and any associated intervention before and after training. DISCUSSION: From a public health perspective, this project has the potential to make a significant impact on reducing risk of harm from substance use disorders among pregnant women, and contribute to better health outcomes for their children. TRIAL REGISTRATION:  This trial has been pre-registered under the Open Science Framework. REGISTRATION: https://doi.org/10.17605/OSF.IO/73FDZ .


Subject(s)
Ethanol , Substance-Related Disorders , Pregnancy , Child , Female , Humans , Retrospective Studies , Australia , Prenatal Diagnosis , Substance-Related Disorders/diagnosis , Substance-Related Disorders/therapy
3.
Article in English | MEDLINE | ID: mdl-37947566

ABSTRACT

INTRODUCTION: We aimed to explore the lived experiences of caesarean birth complicated by impaction of the foetal head, for mothers and midwives. METHODS: A pragmatic, qualitative, focus group study of mixed-participants was conducted, face-to-face. They were postpartum women (n = 4), midwives (n = 4), and a postpartum midwife (n = 1) who had experience of either providing care for impacted foetal head, and/or had experienced it during their own labour, in Fife, United Kingdom. Data were transcribed and were analysed using template analysis. RESULTS: Three main themes emerged through analysis: (i) current knowledge of impacted foetal head; (ii) current management of impacted foetal head; and (iii) experiences and outcomes of impacted foetal head. Each theme was made up of various initial codes when data were analysed inductively. Finally, each theme could be overlaid onto the three core principles of the Tydeman Tube: (1) to improve outcomes for mother and baby in the second stage of labour; (2) to reduce the risk of trauma to mother and baby in complicated births; and (3) to increase respectful care for women in labour; thus allowing for a neat analytic template. CONCLUSION: A lack of consensus regarding definition, management, and training were highlighted by the midwives. Women anticipated caesarean birth in late labour as straightforward and were therefore unaware of this potential complication. Women and midwives would welcome any new device to facilitate delivery of the impacted foetal head (IFH) as long as it is fully evaluated prior to widespread introduction. Women were not averse to being part of this evaluation process.


Subject(s)
Labor, Obstetric , Midwifery , Pregnancy , Female , Humans , Mothers , Focus Groups , Parturition
4.
Midwifery ; 126: 103824, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37714044

ABSTRACT

OBJECTIVE: To explore the concept of sense of coherence as facilitated by water immersion during labour and/or birth. DESIGN: A concept analysis and synthesis. A literature search of CINAHL, Medline, PubMed, PsycINFO and Emcare was undertaken in February 2022. Results were cross-checked with Google Scholar. No timeframe was specified, and results were restricted to research papers written in English. Overall, 2768 papers were retrieved and after removal of duplicates and unrelated papers, abstracts were screened to ensure the paper met the inclusion criteria i.e. women's experiences of water immersion for labour and/or birth. This process yielded a total of 37 articles and two theses, these were used for the concept analysis. Attributes were described and an exemplar case developed after mapping and charting of the data set. FINDINGS: Three attributes were identified; agency, holistic and complete and more than pain relief which align with the three sense of coherence components: comprehensible, meaningfulness and manageability. KEY CONCLUSION: There is a growing evidence base regarding the use of intrapartum water immersion. The literature exploring women's experiences and views of water immersion, appears to consistently report that women experience physiological, physical and psychological benefits and that these benefits complement each other to facilitate greater self-efficacy and a more holistic experience. This combination of benefits afforded by water immersion facilitates a sense of coherence and subsequently, increases the likelihood of the woman experiencing labour and birth as both positive and satisfying. IMPLICATIONS FOR PRACTICE: A greater understanding of women's experiences of water immersion will provide rationale and reason for making the option a real choice while revealing the positive impacts that it can have on all outcomes beyond just the physical.


Subject(s)
Labor, Obstetric , Sense of Coherence , Pregnancy , Female , Humans , Water , Immersion , Labor, Obstetric/psychology , Parturition
5.
Aust N Z J Obstet Gynaecol ; 63(5): 656-665, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37431680

ABSTRACT

Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy liver disease, characterised by pruritus and increased total serum bile acids (TSBA), Australian incidence 0.6-0.7%. ICP is diagnosed by non-fasting TSBA ≥19 µmol/L in a pregnant woman with pruritus without rash without a known pre-existing liver disorder. Peak TSBA ≥40 and ≥100 µmol/L identify severe and very severe disease respectively, associated with spontaneous preterm birth when severe, and with stillbirth, when very severe. Benefit-vs-risk for iatrogenic preterm birth in ICP remains uncertain. Ursodeoxycholic acid remains the best pharmacotherapy preterm, improving perinatal outcome and reducing pruritus, although it has not been shown to reduce stillbirth.

6.
BJOG ; 130(12): e40-e64, 2023 11.
Article in English | MEDLINE | ID: mdl-37303275

ABSTRACT

Over one-quarter of women in the UK have a caesarean birth (CB). More than one in 20 of these births occurs near the end of labour, when the cervix is fully dilated (second stage). In these circumstances, and when labour has been prolonged, the baby's head can become lodged deep in the maternal pelvis making it challenging to deliver the baby. During the caesarean birth, difficulty in delivery of the baby's head may result - this emergency is known as impacted fetal head (IFH). These are technically challenging births that pose significant risks to both the woman and baby. Complications for the woman include tears in the womb, serious bleeding and longer hospital stay. Babies are at increased risk of injury including damage to the head and face, lack of oxygen to the brain, nerve damage, and in rare cases, the baby may die from these complications. Maternity staff are increasingly encountering IFH at CB, and reports of associated injuries have risen dramatically in recent years. The latest UK studies suggest that IFH may complicate as many as one in 10 unplanned CBs (1.5% of all births) and that two in 100 babies affected by IFH die or are seriously injured. Moreover, there has been a sharp increase in reports of babies having brain injuries when their birth was complicated by IFH. When an IFH occurs, the maternity team can use different approaches to help deliver the baby's head at CB. These include: an assistant (another obstetrician or midwife) pushing the head up from the vagina; delivering the baby feet first; using a specially designed inflatable balloon device to elevate the baby's head and/or giving the mother a medicine to relax the womb. However, there is currently no consensus for how best to manage these births. This has resulted in a lack of confidence among maternity staff, variable practice and potentially avoidable harm in some circumstances. This paper reviews the current evidence regarding the prediction, prevention and management of IFH at CB, integrating findings from a systematic review commissioned from the National Guideline Alliance.


Subject(s)
Cesarean Section , Labor, Obstetric , Infant , Female , Pregnancy , Humans , Cesarean Section/adverse effects , Fetus , Uterus , Cervix Uteri
7.
BJOG ; 130(10): 1167-1176, 2023 09.
Article in English | MEDLINE | ID: mdl-36999234

ABSTRACT

OBJECTIVE: To determine whether the Growth Assessment Protocol (GAP) affects the antenatal detection of large for gestational age (LGA) or maternal and perinatal outcomes amongst LGA babies. DESIGN: Secondary analysis of a pragmatic open randomised cluster control trial comparing the GAP with standard care. SETTING: Eleven UK maternity units. POPULATION: Pregnant women and their LGA babies born at ≥36+0  weeks of gestation. METHODS: Clusters were randomly allocated to GAP implementation or standard care. Data were collected from electronic patient records. Trial arms were compared using summary statistics, with unadjusted and adjusted (two-stage cluster summary approach) differences. MAIN OUTCOME MEASURES: Rate of detection of LGA (estimated fetal weight on ultrasound scan above the 90th centile after 34+0  weeks of gestation, defined by either population or customised growth charts), maternal and perinatal outcomes (e.g. mode of birth, postpartum haemorrhage, severe perineal tears, birthweight and gestational age, neonatal unit admission, perinatal mortality, and neonatal morbidity and mortality). RESULTS: A total of 506 LGA babies were exposed to GAP and 618 babies received standard care. There were no significant differences in the rate of LGA detection (GAP 38.0% vs standard care 48.0%; adjusted effect size -4.9%; 95% CI -20.5, 10.7; p = 0.54), nor in any of the maternal or perinatal outcomes. CONCLUSIONS: The use of GAP did not change the rate of antenatal ultrasound detection of LGA when compared with standard care.


Subject(s)
Parturition , Perinatal Mortality , Infant, Newborn , Infant , Female , Pregnancy , Humans , Gestational Age , Birth Weight , Fetus , Randomized Controlled Trials as Topic
8.
Midwifery ; 119: 103621, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36773412

ABSTRACT

OBJECTIVE: To derive a deeper understanding of transgender and non-binary people's experience of pregnancy and birth, and ways to modify practice to provide inclusive care. DESIGN: Case study reports describe the experiences of two transgender and non-binary people who received pregnancy and birth care through a Midwifery Group Practice program. SETTING: A tertiary hospital in metropolitan South Australia with approximately 3800 births per annum. METHODS: Qualitative methodology, utilising open-ended, semi-structured, face-to-face interviews were undertaken postnatally. Interviews were audio recorded and transcribed verbatim to analyse and identify themes. FINDINGS: Both clients feared being misgendered within pregnancy care services. They appreciated the constancy of the Midwifery Group Practice midwife, which meant they did not have to repeat their history to multiple health care providers. They appreciated their pronouns being documented on case notes and welcomed staff attempts to use their preferred terms. Both felt the pregnancy care environment was focussed on cisgender females and found this alienating. They appreciated the midwife's suggestion that the cot card for their baby did not have to be pink or blue. They both suggested staff use more gender-neutral language, and resources, when providing pregnancy care. KEY CONCLUSION: Staff attempted to support these parents, and this was appreciated by them, but the continuity provided by the Midwifery Group Practice model was highly valued by both, regardless of risk status. It was identified that further education for staff was required to facilitate provision of more inclusive care. IMPLICATIONS FOR PRACTICE: The case studies identified a need for greater awareness and education for staff regarding care provision for transgender and non-binary people. Simple adjustments had a big impact. Further research is needed to identify how best to meet the needs of gender-diverse people and address the educational needs of staff.


Subject(s)
Midwifery , Parturition , Pregnancy , Female , Humans , Qualitative Research , Gender Identity , Prenatal Care/methods , Midwifery/methods
9.
Int J Nurs Stud Adv ; 5: 100144, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38746573

ABSTRACT

Background: Workplace bullying, and violence within the midwifery profession, has been a well-documented concern in health literature since the early 1990's. However, contemporary research highlights that workplace bullying, and violence is often inflicted upon midwifery students. Workplace bullying, and violence has both short- and long-term effects on the student, including psychological trauma and poor mental health, loss of passion for the midwifery profession and absenteeism. To consider a solution to this phenomenon, current literature regarding midwifery students' knowledge, understanding and experiences of workplace bullying, and violence has been reviewed. Objective: To explore and critique current literature on midwifery students' knowledge, understanding and experiences of workplace bullying, and violence. Design: An integrative review. Review methods: Toronto & Remington's six-stage systematic framework was used to conduct the review, with rigour and validity for the research process. Results: Following critical appraisal, 12 articles met the inclusion criteria. Four themes emerged: (1) Prevalence and types of workplace bullying, and violence towards midwifery students. (2) Impact of workplace bullying, and violence on midwifery students' experiences during the degree. (3) Impact of negative workplace culture on the midwifery profession. (4) The requirement to develop strategies for midwifery students to address workplace bullying, and violence. Conclusions: Workplace bullying, and violence is a global health concern within the midwifery profession with evidenced impact on midwifery students' professional and personal lives. Organisational systems and approaches were identified as causes of a toxic clinical environment and workplace bullying, and violence, which impacted midwifery students' experiences. Suggestions supported universities incorporating conflict resolution strategies into midwifery degree programs, to prepare midwifery students to manage workplace bullying, and violence. Tweetable abstract: Workplace bullying, and violence is a global health concern entrenched within the midwifery profession, impacting midwifery students' professional and personal lives. Incorporating conflict resolution strategies into Bachelor of midwifery degree programs, may help prepare midwifery students to manage workplace bullying, and violence.

10.
Int J Obes (Lond) ; 46(12): 2145-2155, 2022 12.
Article in English | MEDLINE | ID: mdl-36224375

ABSTRACT

BACKGROUND/OBJECTIVES: Obesity in pregnancy has been associated with increased childhood cardiometabolic risk and reduced life expectancy. The UK UPBEAT multicentre randomised control trial was a lifestyle intervention of diet and physical activity in pregnant women with obesity. We hypothesised that the 3-year-old children of women with obesity would have heightened cardiovascular risk compared to children of normal BMI women, and that the UPBEAT intervention would mitigate this risk. SUBJECTS/METHODS: Children were recruited from one UPBEAT trial centre. Cardiovascular measures included blood pressure, echocardiographic assessment of cardiac function and dimensions, carotid intima-media thickness and heart rate variability (HRV) by electrocardiogram. RESULTS: Compared to offspring of normal BMI women (n = 51), children of women with obesity from the trial standard care arm (n = 39) had evidence of cardiac remodelling including increased interventricular septum (IVS; mean difference 0.04 cm; 95% CI: 0.018 to 0.067), posterior wall (PW; 0.03 cm; 0.006 to 0.062) and relative wall thicknesses (RWT; 0.03 cm; 0.01 to 0.05) following adjustment. Randomisation of women with obesity to the intervention arm (n = 31) prevented this cardiac remodelling (intervention effect; mean difference IVS -0.03 cm (-0.05 to -0.008); PW -0.03 cm (-0.05 to -0.01); RWT -0.02 cm (-0.04 to -0.005)). Children of women with obesity (standard care arm) compared to women of normal BMI also had elevated minimum heart rate (7 bpm; 1.41 to 13.34) evidence of early diastolic dysfunction (e prime) and increased sympathetic nerve activity index by HRV analysis. CONCLUSIONS: Maternal obesity was associated with left ventricular concentric remodelling in 3-year-old offspring. Absence of remodelling following the maternal intervention infers in utero origins of cardiac remodelling. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: The UPBEAT trial is registered with Current Controlled Trials, ISRCTN89971375.


Subject(s)
Carotid Intima-Media Thickness , Pregnancy Complications , Female , Humans , Pregnancy , Child, Preschool , Child , Ventricular Remodeling , Pregnancy Complications/prevention & control , Life Style , Obesity/complications , Obesity/therapy
11.
Implement Sci ; 17(1): 60, 2022 09 05.
Article in English | MEDLINE | ID: mdl-36064428

ABSTRACT

BACKGROUND: Reducing the rate of stillbirth is an international priority. At least half of babies stillborn in high-income countries are small for gestational-age (SGA). The Growth Assessment Protocol (GAP), a complex antenatal intervention that aims to increase the rate of antenatal detection of SGA, was evaluated in the DESiGN type 2 hybrid effectiveness-implementation cluster randomised trial (n = 13 clusters). In this paper, we present the trial process evaluation. METHODS: A mixed-methods process evaluation was conducted. Clinical leads and frontline healthcare professionals were interviewed to inform understanding of context (implementing and standard care sites) and GAP implementation (implementing sites). Thematic analysis of interview text used the context and implementation of complex interventions framework to understand acceptability, feasibility, and the impact of context. A review of implementing cluster clinical guidelines, training and maternity records was conducted to assess fidelity, dose and reach. RESULTS: Interviews were conducted with 28 clinical leads and 27 frontline healthcare professionals across 11 sites. Staff at implementing sites generally found GAP to be acceptable but raised issues of feasibility, caused by conflicting demands on resource, and variable beliefs among clinical leaders regarding the intervention value. GAP was implemented with variable fidelity (concordance of local guidelines to GAP was high at two sites, moderate at two and low at one site), all sites achieved the target to train > 75% staff using face-to-face methods, but only one site trained > 75% staff using e-learning methods; a median of 84% (range 78-87%) of women were correctly risk stratified at the five implementing sites. Most sites achieved high scores for reach (median 94%, range 62-98% of women had a customised growth chart), but generally, low scores for dose (median 31%, range 8-53% of low-risk women and median 5%, range 0-17% of high-risk women) were monitored for SGA as recommended. CONCLUSIONS: Implementation of GAP was generally acceptable to staff but with issues of feasibility that are likely to have contributed to variation in implementation strength. Leadership and resourcing are fundamental to effective implementation of clinical service changes, even when such changes are well aligned to policy mandated service-change priorities. TRIAL REGISTRATION: Primary registry and trial identifying number: ISRCTN 67698474. Registered 02/11/16. https://doi.org/10.1186/ISRCTN67698474 .


Subject(s)
Infant, Small for Gestational Age , Stillbirth , Delivery of Health Care , Female , Fetus , Gestational Age , Humans , Infant, Newborn , Pregnancy , Randomized Controlled Trials as Topic , Review Literature as Topic
12.
Article in English | MEDLINE | ID: mdl-35969720

ABSTRACT

BACKGROUND: Childbirth is a common factor which increases the risk of obstetric anal sphincter injuries (OASIS). Damage to the anal sphincters increases the risk of anal incontinence, which has a debilitating impact on the quality of life. Post-repair laxatives are prescribed in this group of women. However, there is no consensus regarding the type or frequency with which they are used, and available guidelines lack consistency and evidence to support the recommendations. AIM: The aim was to review and compare the international, national and local Australian management guidelines for recommendations regarding laxative use in women after OASIS. METHOD: An online literature search of medical and nursing databases such as PubMed, Embase, MEDLINE, CINAHL, Web of Science, Scopus and Cochrane was performed between January 2000 and October 2020. Full-text articles with MeSH headings and Text Words [TW] identified guidelines in the prevention, management and care of OASIS. The search terms included 'obstetric anal sphincter injury', 'OASIS', 'perineal tear', 'postpartum continence', 'bowel injury', 'aperient', 'laxative use' and 'bulking agents'. RESULTS: Thirteen guidelines were included. Laxatives were recommended in most guidelines; however, there was a lack of consistency regarding the type of laxative used, frequency, dose and duration of use. Guidelines were based on historical evidence, with paucity of recently acquired data identified. CONCLUSIONS: There is no consensus regarding an optimal laxative regime for women who sustain an anal sphincter injury after childbirth. Further research is required to develop evidence-based robust clinical guidelines regarding laxative use in women who sustain OASIS.

13.
EClinicalMedicine ; 50: 101512, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35784438

ABSTRACT

Background: Maternal antenatal depression is associated with offspring psychological disorders, but obesity is also widely implicated in maternal depression and neurodevelopment. In pregnant women with obesity we explored interrelationships between antenatal depressive symptom trajectories and multiple exposures implicated in fetal neurodevelopment which could explain these associations, as a prelude to exploring associations with infant mental health. Methods: The UK Pregnancies Better Eating and Activity Trial (UPBEAT) recruited multi-ethnic pregnant women with obesity (BMI >= 30kg/m2) between March 2009 and June 2014 from 8 UK sites and 1369 were included to model longitudinal antenatal depressive symptoms from Edinburgh Postnatal Depression Scale (EPDS) scores using Latent Class Growth Analysis. Classes were compared on maternal baseline demography, biomarkers of metabolism, inflammation and placental function, infection, diet and by pregnancy and birth outcomes. Odds ratios, mean differences and 95% Confidence Intervals were calculated using robust auxiliary modelling techniques. Findings: The chosen model produced four classes: "Not Depressed" (n=575 [42%], "reference"), "Mild" (n=523 [37·5%]), "Moderate" (n=219 [16%]) and "Severe" (n=62 [4·5%]) symptom trajectories. Socio-economic deprivation and ethnic diversity were greater in Severe and Moderate classes. Dietary glycaemic load and saturated fat intake were higher in Severe and Moderate classes (at 17 and 27 weeks). Higher Interleukin-6, glycoprotein acetyls (17 weeks), glucose (34 weeks) and lower placental growth factor (PlGF, 17 and 27 weeks) was found in the Severe class. PlGF was lower in the Moderate class (27 weeks). Infection was least likely in the Not Depressed class across gestation. Risks of preterm birth were associated with Severe depressive symptoms (aOR 3·05[1·11 to 8·36]). Interpretation: Comprehensive phenotyping exposes important fetal exposures implicated in adverse neurodevelopment, differing by depression class. This study expands substantially on causal models of suboptimal fetal neurodevelopment and offers potential new targets for intervention in obese pregnant women. Funding: JNS was funded by a PhD studentship from the National Institute for Health Research (NIHR) Biomedical Research Centre based at Guy's and St Thomas' NHS Foundation Trust and King's College London. UPBEAT was supported by the European Union's 7th Framework Programme (FP7/2007-2013), project EarlyNutrition; grant agreement no. 289346 and the National Institute for Health Research (NIHR) (UK) Programme Grants for Applied Research Programme (RP-0407-10452), Medical Research Council UK Project Grant (MR/L002477/1). Support was also provided by the Chief Scientist Office Scotland, Guy's and St Thomas' Charity and Tommy's Charity (Registered charity no. 1060508). LP and SLW are funded by Tommy's Charity.

14.
Trials ; 23(1): 571, 2022 Jul 19.
Article in English | MEDLINE | ID: mdl-35854327

ABSTRACT

BACKGROUND: Each year in the UK, approximately 35,000 women develop gestational diabetes mellitus (GDM). The condition increases the risk of obstetric and neonatal complications for mother and child, including preeclampsia, preterm birth, and large for gestational age babies. Biochemical consequences include maternal hyperglycemia, neonatal hypoglycemia, and dyslipidemia. Metformin is the most commonly used firstline pharmacological treatment. However, there are concerns about its widespread use during pregnancy, due to its limited efficacy and potential safety concerns. Therefore, there is a need for additional therapies that improve both maternal-fetal glucose and lipid metabolism. Ursodeoxycholic acid (UDCA) is not currently used for treatment for GDM. However, it can improve glucose control in type 2 diabetes, and it improves fetal lipid profiles in gestational cholestasis. Consequentially, it is hypothesized that treatment with UDCA for women with GDM may improve both maternal metabolism and neonatal outcomes. The primary outcome of this trial is to assess the efficacy of UDCA compared with metformin to improve glucose levels in women with GDM. METHODS: The trial is a two-armed, open-label, multi-center, randomized controlled trial. Women are eligible if they have been diagnosed with GDM by an oral glucose tolerance test between 24 + 0 and 30 + 6 weeks' gestation, and if they require pharmacological intervention. In total, 158 pregnant women will be recruited across seven NHS Trusts in England and Wales. Women who consent will be recruited and randomized to either metformin or UDCA, which will be taken daily until the birth of their baby. Maternal and neonatal blood samples will be taken to evaluate the impact of the treatments on maternal glucose control, and maternal and neonatal lipid metabolism. Maternal and fetal outcomes will be evaluated, and acceptability of UDCA compared with metformin will be assessed. DISCUSSION: This trial has the potential to identify a potential new treatment for women with GDM. If successful, a future large multi-center trial will be designed to investigate where decisions can be personalized to identify which women will respond more effectively to UDCA than alternatives to improve maternal and baby outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04407650.


Subject(s)
Diabetes Mellitus, Type 2 , Diabetes, Gestational , Metformin , Premature Birth , Blood Glucose , Diabetes Mellitus, Type 2/diagnosis , Diabetes Mellitus, Type 2/drug therapy , Diabetes, Gestational/diagnosis , Diabetes, Gestational/drug therapy , Female , Glucose/therapeutic use , Humans , Infant, Newborn , Metformin/adverse effects , Multicenter Studies as Topic , Pregnancy , Randomized Controlled Trials as Topic , Ursodeoxycholic Acid/adverse effects
15.
PLoS Med ; 19(6): e1004004, 2022 06.
Article in English | MEDLINE | ID: mdl-35727800

ABSTRACT

BACKGROUND: Antenatal detection and management of small for gestational age (SGA) is a strategy to reduce stillbirth. Large observational studies provide conflicting results on the effect of the Growth Assessment Protocol (GAP) in relation to detection of SGA and reduction of stillbirth; to the best of our knowledge, there are no reported randomised control trials. Our aim was to determine if GAP improves antenatal detection of SGA compared to standard care. METHODS AND FINDINGS: This was a pragmatic, superiority, 2-arm, parallel group, open, cluster randomised control trial. Maternity units in England were eligible to participate in the study, except if they had already implemented GAP. All women who gave birth in participating clusters (maternity units) during the year prior to randomisation and during the trial (November 2016 to February 2019) were included. Multiple pregnancies, fetal abnormalities or births before 24+1 weeks were excluded. Clusters were randomised to immediate implementation of GAP, an antenatal care package aimed at improving detection of SGA as a means to reduce the rate of stillbirth, or to standard care. Randomisation by random permutation was stratified by time of study inclusion and cluster size. Data were obtained from hospital electronic records for 12 months prerandomisation, the washout period (interval between randomisation and data collection of outcomes), and the outcome period (last 6 months of the study). The primary outcome was ultrasound detection of SGA (estimated fetal weight <10th centile using customised centiles (intervention) or Hadlock centiles (standard care)) confirmed at birth (birthweight <10th centile by both customised and population centiles). Secondary outcomes were maternal and neonatal outcomes, including induction of labour, gestational age at delivery, mode of birth, neonatal morbidity, and stillbirth/perinatal mortality. A 2-stage cluster-summary statistical approach calculated the absolute difference (intervention minus standard care arm) adjusted using the prerandomisation estimate, maternal age, ethnicity, parity, and randomisation strata. Intervention arm clusters that made no attempt to implement GAP were excluded in modified intention to treat (mITT) analysis; full ITT was also reported. Process evaluation assessed implementation fidelity, reach, dose, acceptability, and feasibility. Seven clusters were randomised to GAP and 6 to standard care. Following exclusions, there were 11,096 births exposed to the intervention (5 clusters) and 13,810 exposed to standard care (6 clusters) during the outcome period (mITT analysis). Age, height, and weight were broadly similar between arms, but there were fewer women: of white ethnicity (56.2% versus 62.7%), and in the least deprived quintile of the Index of Multiple Deprivation (7.5% versus 16.5%) in the intervention arm during the outcome period. Antenatal detection of SGA was 25.9% in the intervention and 27.7% in the standard care arm (adjusted difference 2.2%, 95% confidence interval (CI) -6.4% to 10.7%; p = 0.62). Findings were consistent in full ITT analysis. Fidelity and dose of GAP implementation were variable, while a high proportion (88.7%) of women were reached. Use of routinely collected data is both a strength (cost-efficient) and a limitation (occurrence of missing data); the modest number of clusters limits our ability to study small effect sizes. CONCLUSIONS: In this study, we observed no effect of GAP on antenatal detection of SGA compared to standard care. Given variable implementation observed, future studies should incorporate standardised implementation outcomes such as those reported here to determine generalisability of our findings. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry, ISRCTN67698474.


Subject(s)
Fetal Growth Retardation , Infant, Small for Gestational Age , Prenatal Diagnosis , Cluster Analysis , Female , Fetal Growth Retardation/diagnosis , Humans , Infant, Newborn , Pregnancy , Stillbirth
16.
BMC Pregnancy Childbirth ; 22(1): 34, 2022 Jan 15.
Article in English | MEDLINE | ID: mdl-35033006

ABSTRACT

BACKGROUND: The rate of second stage caesarean section (CS) is rising with associated increases in maternal and neonatal morbidity, which may be related to impaction of the fetal head in the maternal pelvis. In the last 10 years, two devices have been developed to aid disimpaction and reduce these risks: the Fetal Pillow (FP) and the Tydeman Tube (TT). The aim of this study was to determine the distance of upward fetal head elevation achieved on a simulator for second stage CS using these two devices, compared to the established technique of per vaginum digital disimpaction by an assistant. METHODS: We measured elevation of the fetal head achieved with the two devices (TT and FP), compared to digital elevation, on a second stage Caesearean simulator (Desperate Debra ™ set at three levels of severity. Elevation was measured by both a single operator experienced with use of the TT and FP and also multiple assistants with no previous experience of using either device. All measurements were blinded RESULTS: The trained user achieved greater elevation of the fetal head at both moderate and high levels of severity with the TT (moderate: 30mm vs 12.5mm p<0.001; most severe: 25mm vs 10mm p<0.001) compared to digital elevation. The FP provided comparable elevation to digital at both settings (moderate: 10 vs 12.5mm p=0.149; severe 10 vs 10mm p=0.44). With untrained users, elevation was also significantly greater with the TT compared to digital elevation (20mm vs 10mm p<0.01). However digital disimpaction was significantly greater than the FP (10mm vs 0mm p<0.0001). CONCLUSION: On a simulator, with trained operators, the TT provided greater fetal head elevation than digital elevation and the FP. The FP achieved similar elevation to the digital technique, especially when the user was trained in the procedure.


Subject(s)
Cesarean Section/instrumentation , Cesarean Section/methods , Models, Anatomic , Version, Fetal/instrumentation , Version, Fetal/methods , England , Female , Head/anatomy & histology , Health Personnel/education , Humans , Labor Stage, Second , Pregnancy , Simulation Training
17.
JMIR Res Protoc ; 11(2): e35558, 2022 Feb 18.
Article in English | MEDLINE | ID: mdl-34995202

ABSTRACT

BACKGROUND: Workplace bullying and violence (WBV) are well-documented issues in the midwifery profession. Negative workplace culture, conflict, and bullying are the most common forms of workplace violence experienced by midwives. Workplace violence increases the risk of midwives experiencing burnout, compassion fatigue, psychological trauma, poor mental health, absenteeism, loss of passion for the midwifery profession, job dissatisfaction, and poor job retention. Midwifery students describe workplace violence in the form of physical, emotional, or verbal abuse, and bullying. Therefore, there is a justification to develop conflict resolution strategies and resilience in midwifery students prior to graduation. OBJECTIVE: Our aim is to develop and facilitate a bespoke education program for South Australian midwifery students to enable them to develop skills in conflict resolution, build resilience, and identify self-care strategies. METHODS: This study will undertake a preparatory phase summarizing the body of literature on midwifery students' knowledge, understanding, and experiences of WBV. Following this, a 3-phase sequential mixed methods research design study will be undertaken. In Phase 1, quantitative data will be collected via a semistructured questionnaire and a validated conflict measurement tool, before and after attending an education workshop, and will be analyzed using descriptive and inferential statistics. Results from Phase 1 will inform and guide the development of an interview schedule for Phase 2. In Phase 2, qualitative data will be gathered by facilitating one-to-one interviews and a thematic analysis will be undertaken to gain a deeper understanding of midwifery students' experiences of WBV. In Phase 3, data integration using triangulation will be undertaken and meta-inferences will be developed via the integration of results and findings from Phases 1 and 2. RESULTS: The preparatory phase will commence in October 2021. Phase 1 will commence in 2022 with analysis of pre- and posteducation results anticipated to be completed by December 2022. Phase 2 will be developed from findings of the preparatory phase and results of Phase 1. An interpretation of verbatim interview transcripts is estimated to be undertaken by April 2023. Phase 3 of the study is expected to commence in May 2023, and this will involve the analysis of collective evidence gathered from Phases 1 and 2. The anticipated completion date for the study is December 2023. CONCLUSIONS: The outcomes of this research will provide insights into the prevalence and impact of WBV experienced by midwifery students. The findings of the research will report on levels of knowledge, skills, and confidence, and will assess the impact of a bespoke conflict resolution and resilience education workshop for midwifery students in managing WBV. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/35558.

18.
Arch Dis Child Fetal Neonatal Ed ; 107(5): 481-487, 2022 Sep.
Article in English | MEDLINE | ID: mdl-34789488

ABSTRACT

BACKGROUND: Maternal obesity may increase offspring risk of cardiovascular disease. We assessed the impact of maternal obesity on cardiac structure and function in newborns as a marker of fetal cardiac growth. METHODS: Neonates born to mothers of healthy weight (body mass index (BMI) 20-25 kg/m2, n=56) and to mothers who were obese (BMI ≥30 kg/m2, n=31) underwent 25-minute continuous ECG recording and non-sedated, free-breathing cardiac MRI within 72 hours of birth. RESULTS: Mean (SD) heart rate during sleep was higher in infants born to mothers who were versus were not obese (123 (12.6) vs 114 (9.8) beats/min, p=0.002). Heart rate variability during sleep was lower in infants born to mothers who were versus were not obese (SD of normal-to-normal R-R interval 34.6 (16.8) vs 43.9 (16.5) ms, p=0.05). Similar heart rate changes were seen during wakefulness. Left ventricular end-diastolic volume (2.35 (0.14) vs 2.54 (0.29) mL/kg, p=0.03) and stroke volume (1.50 (0.09) vs 1.60 (0.14), p=0.04) were decreased in infants born to mothers who were versus were not obese. There were no differences in left ventricular end-systolic volume, ejection fraction, output or myocardial mass between the groups. CONCLUSION: Maternal obesity was associated with increased heart rate, decreased heart rate variability and decreased left ventricular volumes in newborns. If persistent, these changes may provide a causal mechanism for the increased cardiovascular risk in adult offspring of mothers with obesity. In turn, modifying antenatal and perinatal maternal health may have the potential to optimise long-term cardiovascular health in offspring.


Subject(s)
Obesity, Maternal , Adult , Body Mass Index , Female , Heart Rate , Humans , Infant , Infant, Newborn , Obesity/complications , Obesity, Maternal/complications , Pregnancy , Ventricular Function, Left
19.
JMIR Res Protoc ; 11(1): e34372, 2022 Jan 13.
Article in English | MEDLINE | ID: mdl-34848389

ABSTRACT

BACKGROUND: A few recent studies have reported that having the ability to provide self-compassion can reduce health professionals' levels of anxiety and stress, the risk of compassion fatigue, and burnout, and it can generally improve their well-being. Therefore, there is evidence to support further research into the investigation and exploration of self-compassion education and training for health professionals. OBJECTIVE: This study aims to increase the knowledge and understanding of self-compassion and how this may enhance the health and well-being of health professionals. METHODS: The proposed research study will adopt a sequential explanatory mixed methods design. This study will be conducted in 3 phases. Phase 1 will use a pre-educational self-compassion questionnaire (web-based survey) to collect data from participants at 3 time points (before, immediately after, and after follow-up at 6-8 weeks) after they have attended a self-compassion education and training program. Phase 2 will use an interview schedule to explore the participants' views and experiences through a follow-up focus group or individual interview. Finally, phase 3 will include data integration and dissemination of key findings and recommendations. RESULTS: This study was approved by the Women's and Children's Health Network Human Research Ethics Committee and the Human Research Ethics Committee at the University of South Australia on June 26, 2021 (ID: 204,074). A scoping review was conducted to inform this research study (focusing on nurses and midwives). The preparatory phase was completed in April 2021. Phase 1 is expected to be completed by June 2022 and phase 2 will commence in July 2022. CONCLUSIONS: The key findings from the data integration for this research project will provide in-depth details and insights to broaden the discussion about self-compassion and its influence on health professionals' health and well-being. Health professionals (nurses and midwives) may benefit from self-compassion education and training programs to improve their health and well-being. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/34372.

20.
Nutrients ; 13(6)2021 Jun 09.
Article in English | MEDLINE | ID: mdl-34207523

ABSTRACT

Pregnancy can alter a woman's weight gain trajectory across the life course and contribute to the development of obesity through retention of weight gained during pregnancy. This study aimed to identify modifiable determinants associated with postpartum weight retention (PPWR; calculated by the difference in pre-pregnancy and 6 month postpartum weight) in 667 women with obesity from the UPBEAT study. We examined the relationship between PPWR and reported glycaemic load, energy intake, and smoking status in pregnancy, excessive gestational weight gain (GWG), mode of delivery, self-reported postpartum physical activity (low, moderate, and high), and mode of infant feeding (breast, formula, and mixed). At the 6 month visit, 48% (n = 320) of women were at or above pre-pregnancy weight. Overall, PPWR was negative (-0.06 kg (-42.0, 40.4)). Breastfeeding for ≥4 months, moderate or high levels of physical activity, and GWG ≤9 kg were associated with negative PPWR. These three determinants were combined to provide a modifiable factor score (range 0-3); for each added variable, a further reduction in PPWR of 3.0 kg (95% confidence interval 3.76, 2.25) occurred compared to women with no modifiable factors. This study identified three additive determinants of PPWR loss. These provide modifiable targets during pregnancy and the postnatal period to enable women with obesity to return to their pre-pregnancy weight.


Subject(s)
Gestational Weight Gain/physiology , Obesity/physiopathology , Postpartum Period/physiology , Pregnancy Complications/physiopathology , Weight Loss/physiology , Adult , Body-Weight Trajectory , Breast Feeding , Delivery, Obstetric/statistics & numerical data , Energy Intake , Exercise/physiology , Feeding Behavior/physiology , Female , Glycemic Load , Humans , Infant , Infant, Newborn , Maternal Nutritional Physiological Phenomena , Pregnancy , Smoking
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