The far-reaching burden of Hyperemesis Gravidarum - an exploration of women's experiences and perceptions of healthcare support.

Hyperemesis Gravidarum (HG) is a rare condition of pregnancy that exerts a profound effect on a woman's physical and psychological health, but limited research regarding women's perceptions of healthcare for this condition exists. The aim of this study was to gain insight into the personal and healthcare experiences of women with HG. Eligible participants included women who had experienced HG in a current or recent pregnancy and were referred to the dietitian at the National Maternity Hospital, Dublin, Ireland. Suitable women were invited to participate by letter, with a follow-up phone call to confirm eligibility. Four semi-structured focus groups were conducted (n = 11). Audio recordings were transcribed and data was thematically analyzed using an inductive, data-driven approach. Participants emphasized the psychological hardship of HG, which manifested in many different ways, and unveiled the far-reaching burden of HG. Women advocated for a dedicated service for HG and the need for increased knowledge, understanding and support for HG, in order to ensure optimal HG management and woman-centered care. Women also highlighted the need for obvious clinical leadership of HG and a continuum of care throughout pregnancy and post-partum. Improvements to the day ward setting and access to HG-specific mental health support would be welcomed. At a government level, timely resolution of the financial assistance for first-line anti-emetics is needed. Overall, greater awareness and understanding of the condition is needed to improve support from family, friends and colleagues. Further research is warranted to determine whether these recommendations would result in improved pregnancy outcomes.

Valproate utilisation trends among women of childbearing potential in Ireland between 2014 and 2019: A drug utilisation study using interrupted time series.

PURPOSE: This study aimed to examine trends in valproate use among women of childbearing potential (WCBP) aged 16-44 years in Ireland following two European-directed regulatory interventions in December 2014 and April 2018. METHODS: This was a repeated cross-sectional study using monthly national pharmacy claims data, to examine trend changes in the prevalence of valproate use among WCBP pre and post two separate regulatory events in December 2014 and April 2018. Annual population estimates from the Central Statistics Office were used to calculate the prevalence rate per 1000 eligible women. Segmented regression analysis of interrupted time series with negative binomial regression was used to examine rates for WCBP aged 16-44 years, and by 10-year age groups. Prevalence ratios (PR) are presented with 95% confidence intervals (CIs). RESULTS: Among WCBP aged 16-44 years, there was no statistically significant change in the month-to-month prevalence ratio in the post- compared to pre-December 2014 intervention period. A significant decline was, however, observed in the post-, compared to pre-April 2018 intervention period (PR = 0.998, [95% CIs: 0.996, 1.000]; p = 0.029). Among those aged 16-24 years, a significant decreasing trend in the month-to-month prevalence ratio was found in the post- compared to pre-December 2014 intervention period (PR = 0.991, [95% CIs: 0.984, 0.998];p <0.01). A marginal effect was observed in the post- compared to pre-April 2018 intervention period for those aged 25-34 years (PR = 0.996, [95% CIs: 0.992, 1.000]; p = 0.048). CONCLUSION: Although no evidence of change was observed following the December 2014 intervention period, a significant decline in the prevalence ratio of valproate use was observed after the 2018 intervention, which may reflect the introduction of the most recent contraindication measures.

Impact of probiotics in women with gestational diabetes mellitus on metabolic health: a randomized controlled trial.

OBJECTIVE: Probiotics are live microorganisms that may confer health benefits on the host. Recent trials of probiotic use among healthy pregnant women demonstrate potential for improved glycemic control. The aim of this study was to investigate the effects of a probiotic capsule intervention on maternal metabolic parameters and pregnancy outcome among women with gestational diabetes. STUDY DESIGN: This double-blind placebo-controlled randomized trial recruited pregnant women with a new diagnosis of gestational diabetes or impaired glucose tolerance following a 3-hour 100-g glucose tolerance test. Women were randomized to a daily probiotic (Lactobacillus salivarius UCC118) or placebo capsule from diagnosis until delivery. Fasting blood samples were collected at baseline and 4-6 weeks after capsule commencement for analysis of glucose, insulin, c-peptide, and lipids. The primary outcome was difference in fasting glucose postintervention, first analyzed on an intention-to-treat basis and followed by per-protocol analysis that excluded women commenced on pharmacological therapy (insulin or metformin). Secondary outcomes were changes in insulin, c-peptide, homeostasis model assessment and lipids, requirement for pharmacological therapy, and neonatal anthropometry. RESULTS: Of 149 women recruited and randomized, there were no differences between the probiotic and placebo groups in postintervention fasting glucose (4.65 ± 0.49 vs 4.65 ± 0.53 mmol/L; P = 373), requirement for pharmacological therapy (17% vs 14%; P = .643), or birthweight (3.57 ± 0.64 vs 3.60 ± 0.57 kg; P = .845). Among 100 women managed with diet and exercise alone, fasting plasma glucose decreased significantly within both the probiotic (4.76 ± 0.45 to 4.57 ± 0.42 mmol/L; P < .001) and placebo (4.85 ± 0.58 to 4.58 ± 0.45 mmol/L; P < .001) groups, but the levels between groups did not differ (P = .316). The late gestation-related rise in total and low-density lipoprotein (LDL) cholesterol was attenuated in the probiotic vs the placebo group (+0.27 ± 0.48 vs +0.50 ± 0.52 mmol/L total cholesterol, P = .031; +0.08 ± 0.51 vs +0.31 ± 0.45 mmol/L LDL cholesterol, P = .011). No differences were noted between groups in other metabolic parameters or pregnancy outcome. CONCLUSION: A probiotic capsule intervention among women with abnormal glucose tolerance had no impact on glycemic control. The observed attenuation of the normal pregnancy-induced rise in total and LDL cholesterol following probiotic treatment requires further investigation, particularly in this obstetric group at risk of future metabolic syndrome.

The IRIS clinic: A Protocol for a mixed-methods study evaluating the management of Hyperemesis Gravidarum.

Background: Hyperemesis Gravidarum (HG) is a severe form of nausea and vomiting in pregnancy that affects 0.3-3% of women and has profound nutritional, physical and psychological consequences. Research is lacking regarding the most effective management of the condition. In response to patient feedback, a multidisciplinary HG day-case service (IRIS Clinic) was launched in 2020 at The National Maternity Hospital, Ireland. The clinic provides routine, day-case care in a comfortable space with pre-booked appointments. The MDT involves midwives, dietitians, perinatal mental health, obstetrics and pharmacy, and the nature of the clinic enables peer-to-peer support. As this clinic is the first of its kind in Ireland, we aim to assess its effectiveness and feasibility, and suggest recommendations for improvement. Methods: This is a sequential, mixed-methods study that commenced in August 2021. The prospective arm of the study is ongoing and involves enrolling women (n = 50) who are attending the IRIS clinic. Data are collected on first admission (pre-intervention) and approximately 8 weeks' later (post-intervention) relating to symptoms of HG, well-being, food tolerances, quality of life and nutritional intake. Qualitative, semi-structured interviews will be conducted to evaluate women's experiences of attending the clinic. The retrospective arm of the study will be a chart review (n = 200) of women diagnosed with HG to describe assessments, treatments and pregnancy and birth outcomes. Conclusion: The IRIS clinic has the potential to improve pregnancy outcomes and nutritional status among women with HG. If found to be effective and feasible, the model for this clinic could be replicated elsewhere.

The influence of a low glycemic index dietary intervention on maternal dietary intake, glycemic index and gestational weight gain during pregnancy: a randomized controlled trial.

BACKGROUND: Maternal diet is known to impact pregnancy outcome. Following a low glycemic index (GI) diet during pregnancy has been shown to improve maternal glycemia and reduce infant birthweight and may be associated with a higher fibre intake. We assessed the impact of a low GI dietary intervention on maternal GI, nutritional intake and gestational weight gain (GWG) during pregnancy. Compliance and acceptability of the low GI diet was also examined. METHOD: Eight hundred women were randomised in early pregnancy to receive low GI and healthy eating dietary advice or to receive standard maternity care. The intervention group received dietary advice at a group education session before 22 weeks gestation. All women completed a 3 day food diary during each trimester of pregnancy. Two hundred and thirty five women from the intervention arm and 285 women from the control arm returned complete 3x3d FDs and were included in the present analysis. RESULTS: Maternal GI was significantly reduced in the intervention group at trimester 2 and 3. The numbers of women within the lowest quartile of GI increased from 37% in trimester 1 to 52% in trimester 3 (P < 0.001) among the intervention group. The intervention group had significantly lower energy intake (P < 0.05), higher protein (% TE) (P < 0.01) and higher dietary fibre intake (P < 0.01) post intervention. Consumption of food groups with known high GI values were significantly reduced among the intervention group. Women in the intervention low GI group were less likely to exceed the Institute of Medicine's GWG goals. CONCLUSION: A dietary intervention in early pregnancy had a positive influence on maternal GI, food and nutrient intakes and GWG. Following a low GI diet may be particularly beneficial for women at risk of exceeding the GWG goals for pregnancy.

Women's experiences of Hyperemesis Gravidarum (HG) and of attending a dedicated multi-disciplinary hydration clinic.

PROBLEM: Hyperemesis Gravidarum (HG) is a severe form of nausea and vomiting in pregnancy that affects 1-3 % of women and has profound nutritional, physical and psychological consequences. Previous research identified that women with HG report inadequate infrastructure for day case management. INTRODUCTION: A multi-disciplinary HG day case service (IRIS Hydration Clinic) was launched and provides routine care for women with HG in a dedicated unit. The multi-disciplinary team involves midwives, dietitians, obstetricians and perinatal mental health. AIMS: To explore women's experiences of HG and of attending the dedicated clinic. METHODS: Ten interviews were conducted with women who attended the clinic. Data were transcribed and analysed using Reflexive Thematic Analysis. FINDINGS: The physical and psychological impact of HG was captured. The appreciation for the dedicated clinic was a common theme, regarding having somewhere specific for treatment rather than ad-hoc treatment. 'Relationships' was a significant theme - women described the benefits of continuity of care and the positive impact of peer support. Areas for improvement were explored, such as expansion and extra sensitivity around some women's issues around weight gain/loss. DISCUSSION: HG causes significant ill-health and its impact remains undervalued. Women had highly positive experiences of attending the dedicated HG clinic. The impact of continuity and individualized care in a day-case setting improved women's experiences of this condition. CONCLUSION: The dedicated HG clinic was highly valued by women experiencing the condition. The IRIS clinic provides much-needed validation for a medical condition with little understanding from the general public or many healthcare professionals.

Awareness, knowledge and practice of healthcare professionals following implementation of a Pregnancy Prevention Program for sodium valproate in Ireland: a multi-stakeholder cross-sectional study.

OBJECTIVES: To establish awareness, knowledge, use and experience in practice of a sodium valproate pregnancy prevention program (PPP) in Ireland ("prevent") among three healthcare professional (HCP) groups. METHODS: A cross-sectional study using anonymous online surveys was conducted among general practitioners (GPs), pharmacists, and specialist consultants. Descriptive analyses are presented. RESULTS: HCP response rates were 5.8% for GPs (90/1544), 10.7% for pharmacists (219/2052), and 7.6% for specialists (17/224). Across HCP groups, there was high awareness (>90%) for specialist referral when female valproate patients are planning pregnancy, or become pregnant, but less awareness to refer annually for specialist review. While awareness of a possible teratogenic effect at any stage of pregnancy was high (>80%), most GPs (62.2%, 95% CI: 51.3, 71.9%) and community pharmacists (53.1%, 95% CI: 43.2, 62.8%) were unsure of the magnitude of risk for developmental disorders, while most specialists under-estimated this risk (46.7%, 95% CI: 24.8, 69.9%). Although >70% of the respondents identified valproate to be contraindicated in any woman of childbearing potential unless the conditions of the PPP are fulfilled, experience implementing key elements in practice varied. CONCLUSIONS: Our findings suggest continued effort is needed to ensure optimal implementation of "prevent" into clinical practice in Ireland.

Maternal metabolic response to dietary treatment for impaired glucose tolerance and gestational diabetes mellitus.

BACKGROUND: Dietary advice is a standard component of treatment for pregnant women with impaired glucose tolerance (IGT) and gestational diabetes (GDM), yet few studies report glycemic profiles in response to dietary therapies and the optimal dietary approach remains uncertain. AIM: To assess changes in maternal glycemic profile and pregnancy outcomes among women with diet-controlled IGT and GDM. METHODS: Pregnant women who had one or more elevated values on a 3-h oral glucose tolerance test were enrolled. All participants received dietary advice and glucose monitoring as part of routine clinical care. Fasting and 1-h post-prandial blood samples, collected prior to initiation of clinical treatment and repeated 4-6 weeks later, were analyzed for glucose, insulin, and C-peptide. Homeostasis model assessment of insulin resistance (HOMA-IR) was calculated. Women who required pharmacological therapy for glucose control were excluded from analyses. RESULTS: Participants (N = 93) were of moderately older age (mean 33 years), with a high rate of overweight/obesity (mean body mass index (BMI) = 28.65 kg/m2), and were diagnosed late in gestation (mean 29 weeks). Fasting (mean ± SD 4.82 ± 0.53 to 4.60 ± 0.42 mmol/l; p < 0.001) and post-prandial glucose (7.01 ± 1.19 to 6.47 ± 1.10; p = 0.004) decreased significantly following the intervention. Baseline HOMA-IR was elevated (3.12 ± 1.03) but did not significantly decrease (2.78 ± 1.52; p = 0.066). There were high rates of macrosomia (24.7%) and cesarean delivery (32.3%). CONCLUSIONS: Although improvements in blood glucose levels were observed among women with diet-controlled IGT and GDM, this was insufficient to significantly affect insulin resistance or perinatal outcome. Late diagnosis and treatment of IGT/GDM may have contributed to such outcomes.

Effects of ball-milling and cryomilling on sulfamerazine polymorphs: a quantitative study.

The effects of ball-milling and cryomilling on sulfamerazine forms I and II (SMZ FI, FII) were investigated using X-ray powder diffraction, infrared and near-infrared (NIR) spectroscopy. Cryomilling resulted in a complete amorphization of both polymorphs. Milling at room temperature gave mixtures of amorphous SMZ (FA) and FII. Calibration models were developed for the quantitative analysis of binary (FI/FII, FI/FA, and FII/FA) and ternary (FI/FII/FA) mixtures using NIR spectroscopy combined with partial least-squares (PLS) regression. The PLS models for binary (0%-100%), ternary (0%-100%), and low-level (0%-10%) binary mixtures had root-mean-square errors of prediction of ≤1.8%, ≤5.1%, and ≤0.80%, respectively. The calibration models were used to obtain a detailed quantitative picture of solid-state transformations during milling and any subsequent recrystallizations. FA prepared by cryomilling FI for less than 60 min recrystallized to mixtures of FI and FII, whereas samples milled for more than 60 min crystallized to pure FII. The effect of comilling SMZ with stoichiometric amounts of additives was investigated. SMZ formed amorphous materials with oxalic, dl-tartaric, and citric acids that were more stable toward recrystallization than FA. Amorphous SMZ/oxalic acid was found to recrystallize to a 2:1 cocrystal during storage.