Supporting self-management in women with pre-existing diabetes in pregnancy: a mixed-methods sequential comparative case study.

INTRODUCTION: Maternal glycemia is associated with pregnancy outcomes. Thus, supporting the self-management experiences and preferences of pregnant women with type 1 and type 2 diabetes is crucial to optimize glucose control and perinatal outcomes. RESEARCH DESIGN AND METHODS: This paper describes the mixed methods integration of a sequential comparative case study. The objectives are threefold, as we integrated the quantitative and qualitative data within the overall mixed methods design: (1) to determine the predictors of glycemic control during pregnancy; (2) to understand the experience and diabetes self-management support needs during pregnancy among women with pre-existing diabetes; (3) to assess how self-management and support experiences helpe to explain glycemic control among women with pre-existing diabetes in pregnancy. The purpose of the mixing was to integrate the quantitative and qualitative data to develop rich descriptive cases of how diabetes self-management and support experiences and preferences in women with type 1 and type 2 diabetes during pregnancy help explain glucose control. A narrative approach was used to weave together the statistics and themes and the quantitative results were integrated visually alongside the qualitative themes to display the data integration. RESULTS: The quantitative results found that women achieved "at target" glucose control (mean A1C of the cohort by the third visit: 6.36% [95% Confidence Interval 6.11%, 6.60%]). The qualitative findings revealed that feelings of fear resulted in an isolating and mentally exhausting pregnancy. The quantitative data also indicated that women reported high levels of self-efficacy that increased throughout pregnancy. Qualitative data revealed that women who had worked hard to optimize glycemia during pregnancy were confident in their self-management. However, they lacked support from their healthcare team, particularly around self-management of diabetes during labour and delivery. CONCLUSIONS: The achievement of optimal glycemia during pregnancy was motivated by fear of pregnancy complications and came at a cost to women's mental health. Mental health support, allowing women autonomy, and the provision of peer support may improve the experience of diabetes self-management during pregnancy. Future work should focus on developing, evaluating and implementing interventions that support these preferences.

Trends and Self-Management Predictors of Glycemic Control During Pregnancy in Women With Preexisting Type 1 or Type 2 Diabetes: A Cohort Study.

Background: Because much of diabetes management during pregnancy occurs at home, self-management factors such as self-efficacy, self-care activities, and care satisfaction may affect glycemia. Our objective was to explore trends in glycemic control during pregnancy in women with type 1 or type 2 diabetes; assess self-efficacy, self-care, and care satisfaction; and examine these factors as predictors of glycemic control. Methods: We conducted a cohort study from April 2014 to November 2019 at a tertiary center in Ontario, Canada. Self-efficacy, self-care, care satisfaction, and A1C were measured three times during pregnancy (T1, T2, and T3). Linear mixed-effects modeling explored trends in A1C and examined self-efficacy, self-care, and care satisfaction as predictors of A1C. Results: We recruited 111 women (55 with type 1 diabetes and 56 with type 2 diabetes). Mean A1C significantly decreased by 1.09% (95% CI -1.38 to -0.79) from T1 to T2 and by 1.14% (95% CI -1.43 to -0.86) from T1 to T3. Self-efficacy significantly predicted glycemic control for women with type 2 diabetes and was associated with a mean change in A1C of -0.22% (95% CI -0.42 to -0.02) per unit increase in scale. The exercise subscore of self-care significantly predicted glycemic control for women with type 1 diabetes and was associated with a mean change in A1C of -0.11% (95% CI -0.22 to -0.01) per unit increase in scale. Conclusion: Self-efficacy significantly predicted A1C during pregnancy in a cohort of women with preexisting diabetes in Ontario, Canada. Future research will continue to explore the self-management needs and challenges in women with preexisting diabetes in pregnancy.

Understanding the self-management experiences and support needs during pregnancy among women with pre-existing diabetes: a qualitative descriptive study.

BACKGROUND: With the increasing prevalence of pre-existing type 1 and type 2 diabetes in pregnancy and their associated perinatal risks, there is a need to focus on interventions to achieve optimal maternal glycemia to improve pregnancy outcomes. One strategy focuses on improving diabetes self-management education and support for expectant mothers with diabetes. This study's objective is to describe the experience of managing diabetes during pregnancy and identify the diabetes self-management education and support needs during pregnancy among women with type 1 and type 2 diabetes. METHODS: Using a qualitative descriptive study design, we conducted semi-structured interviews with 12 women with pre-existing type 1 or 2 diabetes in pregnancy (type 1 diabetes, n = 6; type 2 diabetes, n = 6). We employed conventional content analyses to derive codes and categories directly from the data. RESULTS: Four themes were identified that related to the experiences of managing pre-existing diabetes in pregnancy; four others were related to the self-management support needs in this population. Women with diabetes described their experiences of pregnancy as terrifying, isolating, mentally exhausting and accompanied by a loss of control. Self-management support needs reported included healthcare that is individualized, inclusive of mental health support and support from peers and the healthcare team. CONCLUSIONS: Women with diabetes in pregnancy experience feelings of fear, isolation and a loss of control, which may be improved through personalized management protocols that avoid "painting everybody with the same brush" as well as peer support. Further examination of these simple interventions may yield important impacts on women's experience and sense of connection.

Availability of Safe and Effective Therapeutic Options to Pregnant and Lactating Individuals Following the United States Food and Drug Administration Pregnancy and Lactation Labeling Rule.

OBJECTIVE: To explore the extent and type of pregnancy and lactation data of newly approved prescription drugs and assess whether the presented recommendations are data-driven, as required by the US Food and Drug Administration Pregnancy and Lactation Labeling Rule implemented in 2015. STUDY DESIGN: In this descriptive analysis, we reviewed pregnancy and lactation data of all new molecular entities approved between 2001 and 2020 in their most updated labeling. Information was collected regarding the pregnancy and lactation risk statements, the source of pregnancy and lactation data, and the design and methods of pregnancy and lactation studies in the labeling. RESULTS: Of the 422 new molecular entities, the key advisory statement for use of 133 (32%) drugs in pregnancy and 194 (46%) drugs in lactation were classified as "against use." Less than 2% of all drugs had a key advisory statement that supported their use during pregnancy or lactation. The sources of data regarding use in pregnancy were studies in human and animals in 46 (11%) and 348 (82%) drugs, respectively. For use during lactation, data included studies in human and animals in 23 (5%) and 251 (59%) drugs, respectively. The key advisory recommendation was consistent with the available human information in 4 (8%) drugs in pregnancy and 3 (13%) drugs in lactation. Prescription drug labeling contains limited data to support informed decision-making for the use of prescription drugs during pregnancy/lactation. Close collaboration among stakeholders is required to enhance the availability of data in this population.

Patient-reported Benefits and Limitations of Mobile Health Technologies for Diabetes in Pregnancy: A Scoping Review.

OBJECTIVES: For women with pre-existing and gestational diabetes, pregnancy involves specialized and intensive medical care to optimize maternal and infant outcomes. Medical management for patients with diabetes in pregnancy typically occurs via frequent face-to-face outpatient appointments. COVID-19-induced barriers to face-to-face care have identified the need for high-quality, patient-centred virtual health-care modalities, such as mobile health (mHealth) technologies. Our aim in this review was to identify the patient-reported benefits and limitations of mHealth technologies among women with diabetes in pregnancy. We also aimed to determine how the women's experiences aligned with the best practice standards for patient-centred communication. METHODS: The framework presented by Arksey and O'Malley for conducting scoping reviews, with refinements by Levac et al, was used to guide this review. Relevant studies were identified through comprehensive database searches of MEDLINE, Embase, Emcare and PsycINFO. Thomas and Harden's methods for the thematic synthesis of qualitative research in systematic reviews guided the synthesis of patient-reported benefits and limitations of mHealth technology. RESULTS: Overall, 19 studies describing the use of 16 unique mHealth technologies among 742 women were included in the final review. Patient-reported benefits of mHealth included convenience, support of psychosocial well-being and facilitation of diabetes self-management. Patient-reported limitations included lack of important technological features, perceived burdensome aspects of mHealth and lack of trust in virtual health care. CONCLUSIONS: Women with diabetes report some benefits from mHealth use during pregnancy. Codesigning future technologies with end users may help address the perceived limitations and effectiveness of mHealth technologies.

Efficacy and Safety of Vasopressin and Terlipressin in Preterm Neonates: A Systematic Review.

INTRODUCTION: The use of arginine vasopressin (AVP) and terlipressin to treat hypotension in preterm neonates is increasing. Our aim was to review the available evidence on the efficacy and safety of AVP and terlipressin for use in preterm neonates. METHODS: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Web of Science, and Google Scholar from inception to September 2021 were searched for studies of AVP and terlipressin in the treatment of hypotension of any cause in preterm neonates. Primary outcomes were improvement in end-organ perfusion and mortality. The risk of bias assessment and certainty of the evidence were performed using appropriate tools. RESULTS: Fifteen studies describing the use of AVP (n = 12) or terlipressin (n = 3) among 148 preterm neonates were included. Certainly, the available evidence for the primary outcome of end-organ perfusion rated as very low. AVP or terlipressin were used to treat 144 and 4 neonates, respectively. Improvement in markers of end-organ perfusion was reported in 143 (99%) neonates treated with AVP and 3 (75%) treated with terlipressin. The mortality rate was 41% (n = 59) and 50% (n = 2) for neonates who received AVP and terlipressin, respectively. Hyponatremia was the most frequently reported adverse event (n = 37, 25%). CONCLUSION: AVP and terlipressin may improve measured blood pressure values and possibly end-organ perfusion among neonates with refractory hypotension. However, the efficacy-safety balance of these drugs should be assessed on an individual basis and as per the underlying cause. Studies on the optimal dosing, efficacy, and safety of AVP and terlipressin in preterm neonates with variable underlying conditions are critically needed.

Supporting self-management in women with pre-existing diabetes in pregnancy: a protocol for a mixed-methods sequential comparative case study.

INTRODUCTION: For women with pre-existing type 1 and type 2 diabetes, glycaemic targets are narrow during the preconception and prenatal periods to optimise pregnancy outcomes. Women aim to achieve glycaemic targets during pregnancy through the daily tasks of diabetes self-management. Diabetes self-management during pregnancy involves frequent self-monitoring of blood glucose and titration of insulin based on glucose measures and carbohydrate intake. Our objective is to explore how self-management and support experiences help explain glycaemic control among women with pre-existing diabetes in pregnancy. METHODS AND ANALYSIS: We will conduct a four-phased mixed-methods sequential comparative case study. Phase I will analyse the data from a prospective cohort study to determine the predictors of glycaemic control during pregnancy related to diabetes self-management among women with pre-existing diabetes. In phase II, we will use the results of the cohort analysis to develop data collection tools for phase III. Phase III will be a qualitative description study to understand women's diabetes education and support needs during pregnancy. In phase IV, we will integrate the results of phases I and III to generate unique cases representing the ways in which self-management and support experiences explain glycaemic control in pregnancy. ETHICS AND DISSEMINATION: The phase I cohort study received approval from our local ethics review board, the Hamilton Integrated Ethics Review Board. We will seek ethics approval for the phase III qualitative study prior to its commencement. Participants will provide informed consent before study enrolment. We plan to publish our results in peer-reviewed journals and present our findings to stakeholders at relevant conferences/symposia.

Long-Term Safety of Prenatal and Neonatal Exposure to Paracetamol: A Systematic Review.

INTRODUCTION: Paracetamol is the most commonly used antipyretic and analgesic in pregnancy. It is also increasingly used off-label in the neonatal intensive care unit. Despite the frequent use of paracetamol, concerns have been raised regarding the high variability in neonatal dosing regimens and the long-term safety of early life exposure. OBJECTIVE: To investigate the available evidence on the long-term safety of prenatal and neonatal paracetamol exposure. METHODS: We conducted a systematic search of the electronic databases Ovid Medline, Ovid Embase and Web of Science from inception to August 2021 for original research studies of any design that described the use of paracetamol in the prenatal or neonatal (within the first four weeks of life) periods and examined the occurrence of neurodevelopmental, atopic or reproductive adverse outcomes at or beyond birth. RESULTS: We identified 1313 unique articles and included 30 studies in the final review. Of all studies, 27 (90%), two (7%) and one (3%) were on the long-term safety of prenatal, neonatal and both prenatal and neonatal exposure, respectively. Thirteen (46%), 11 (39%) and four (15%) studies examined neurodevelopmental, atopic and reproductive outcomes. Eleven (100%), 11 (100%), and three (27%) studies on prenatal exposure reported adverse neurodevelopmental, atopic and reproductive outcomes. Only one study found a possible correlation between neonatal paracetamol exposure and long-term adverse outcomes. CONCLUSIONS: The available evidence, although limited, suggests a possible association between prenatal paracetamol exposure and an increased risk of neurodevelopmental, atopic and reproductive adverse outcomes. There is an immediate need for robust data on the long-term safety of paracetamol exposure in the prenatal and neonatal periods.

Patient-Reported Benefits and Limitations of Mobile Health Technologies for Diabetes in Pregnancy: Protocol for a Scoping Review.

BACKGROUND: For women with pre-existing and gestational diabetes mellitus, pregnancy involves specialized and intensive medical care to improve maternal and infant outcomes. Medical management for patients with diabetes in pregnancy typically occurs via frequent face-to-face outpatient appointments. Barriers to face-to-face care during the COVID-19 pandemic have signaled the need for high-quality, patient-centered virtual health care modalities, such as mobile health (mHealth). OBJECTIVE: The objective of the proposed scoping review is to identify the patient-reported benefits and limitations of mHealth technology among women with diabetes in pregnancy. We also aim to determine how the women's experiences align with the best practice standards for patient-centered communication. METHODS: Arksey and O'Malley's framework for conducting scoping reviews with refinements by Levac et al will be used to guide the conduct of this scoping review. Relevant studies will be identified through comprehensive database searches of MEDLINE, Embase, Emcare, and PsycINFO. Following database searches, studies will be screened for eligibility at the title, abstract, and full-text level by two independent reviewers, with the inclusion of a third reviewer if required to reach consensus. Data charting of included studies will be conducted by one reviewer using a standardized data extraction form and verified independently by a second reviewer. Synthesis of results will be guided by Thomas and Harden's "Methods for the Thematic Synthesis of Qualitative Research in Systematic Reviews." RESULTS: As of August 2020, we have carried out the qualitative searches in the electronic databases MEDLINE, Embase, Emcare, and PsycINFO (Ovid interface) for a combined total of 8207 articles. Next, we plan to conduct the quantitative searches in the electronic databases MEDLINE, Embase, and Emcare (Ovid interface). We also plan to review the reference lists of relevant studies to identify additional eligible studies. CONCLUSIONS: With the results of this review, we hope to describe the patient-reported benefits and limitations of mHealth technology for women with diabetes in pregnancy. Furthermore, we aim to determine how women's experiences align with the best practice standards for patient-centered communication. Ultimately, our review can provide valuable information for guideline developers, policy makers, and clinicians related to mobile technologies to support virtual care delivery for women with diabetes in pregnancy. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/29727.

Efficacy and safety of vasopressin and terlipressin in preterm neonates: a protocol for a systematic review.

Background: The use of vasoactive agents like arginine vasopressin (AVP) and terlipressin to treat hypotension or persistent pulmonary hypertension in critically ill preterm neonates is increasing. Therefore, a systematic review of the available data on dosing, efficacy and safety of AVP and terlipressin in this patient population appears beneficial. Methods: We will conduct a systematic review of the available evidence on the use of AVP and terlipressin for the treatment of hypotension or persistent pulmonary hypertension in preterm neonates. We will search Ovid MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Web of Science and Google Scholar from inception to March 2021. Two reviewers will independently screen titles and abstracts, review the full text of eligible studies, extract data, assess the risk of bias and judge the certainty of the evidence. Our primary outcome will be an (1) improvement of end-organ perfusion after initiation of AVP or terlipressin and (2) mortality prior to discharge. Our secondary outcomes will include (1) major neurosensory abnormality and (2) the occurrence of adverse events. Discussion: The currently available evidence on the efficacy and safety of AVP and terlipressin in preterm neonates is limited. Yet, evidence on the pharmacology of these drugs and the pathophysiology of vasoplegic shock support the biological plausibility for their clinical effectiveness in this population. Therefore, we aim to address this gap concerning the use of vasopressin and terlipressin among critically ill preterm neonates. Trial registration: This protocol has been submitted for registration to the international database of prospectively registered systematic reviews (PROSPERO, awaiting registration number).

Topical nitroglycerin ointment as salvage therapy for peripheral tissue ischemia in newborns: a systematic review.

BACKGROUND: Topical nitroglycerin (TNG) ointment has been used for almost 3 decades to treat neonatal peripheral tissue ischemia, but this product is now no longer being produced by its Canadian manufacturer. Our aim was to investigate the efficacy and safety of TNG products in newborns in neonatal intensive care units. METHODS: In this systematic review we searched Embase, CINAHL, MEDLINE, PubMed and Web of Science from inception to April 2020 for studies on the use of TNG products (TNG ointment, TNG spray, glyceryl trinitrate [GTN] patch) for the treatment of neonatal tissue ischemia. We did not apply language or study design limitations. Animal studies and duplicate records were excluded. Two reviewers screened and extracted data. The Tool for Evaluating the Methodological Quality of Case Reports and Case Series was used to assess the risk of bias of individual studies. RESULTS: We included 23 articles (20 case reports, 2 case series and 1 retrospective audit) describing the use of TNG ointment, TNG spray or GTN patch in the treatment of 39 tissue ischemia events in 37 newborns. Twenty-three (62.2%), 12 (32.4%), 1 (2.7%) and 1 (2.7%) infants received TNG ointment, GTN patch, both TNG ointment and GTN patch, and TNG spray, respectively. Nineteen (76.0%) and 7 (53.8%) injuries treated with TNG ointment and GTN patch showed complete recovery, respectively. Two (16.7%) infants treated with GTN patch experienced adverse events (i.e., methemoglobinemia) requiring treatment discontinuation. INTERPRETATION: TNG ointment presents a safe therapeutic modality for salvage therapy of neonatal tissue ischemia. Engagement of stakeholders is essential to address its recent commercial inaccessibility in Canada.

Self-management education among women with pre-existing diabetes in pregnancy: A scoping review.

BACKGROUND: Education is a cornerstone of self-management for adults with diabetes. Self-management is particularly important during pregnancy for women with type 1 and type 2 diabetes, as perinatal outcomes are affected by maternal glycemic control. To our knowledge, literature describing the provision of diabetes education and support during pregnancy for women with type 1 and type 2 diabetes has not been synthesized, nor examined within its context as a complex intervention. OBJECTIVES AND DESIGN: This scoping review aims to synthesize the evidence regarding prenatal diabetes education and support for women with type 1 and type 2 diabetes and to apply the Medical Research Council framework for complex interventions where appropriate. DATA SOURCES AND METHODS: We searched EMBASE, CINAHL, and MEDLINE from inception to February 2019 for primary studies focused on prenatal diabetes education among women with type 1 and type 2 diabetes. Two independent reviewers screened eligible studies against inclusion criteria. A narrative synthesis of the included studies was conducted. RESULTS: Of 511 identified citations, 30 studies were included in the final review. Approximately 44% of the pooled sample were women with type 1 diabetes, 46% had gestational diabetes mellitus, and 10% had type 2 diabetes. Education focused on self-monitoring of blood glucose, attaining glycemic targets, and following a healthy diet. Many studies included educational elements that went beyond traditional didactic teaching and promoted self-management skills and self-management support. The majority of education was delivered via one-on-one outpatient appointments every one to three weeks. About half of the reviewed studies used a multidisciplinary team approach, with most including a combination of physicians, nurses, dietitians, and midwives. Application of the Medical Research Council framework revealed that most studies were limited in methods (i.e., randomization) and few examined process evaluation or intervention cost-effectiveness. CONCLUSION: We identified a lack of studies centred on educational interventions for women with type 2 diabetes in pregnancy. As pregnancy for women with type 2 diabetes involves significant changes, including the transition from oral hypoglycemics to insulin therapy, often without exposure to diabetes-specific preconception care and counselling, future research may focus on optimizing preconception and prenatal education and support for this high-risk group. This is particularly relevant as the prevalence of type 2 diabetes is increasing worldwide. Future research ought to also design, implement and evaluate interventions in accordance with the Medical Research Council framework for complex interventions.

Efficacy and safety of low-dose versus high-dose hydrocortisone to treat hypotension in neonates: a protocol for a systematic review and meta-analysis.

BACKGROUND: Impaired adrenal function is a well-described entity in critically ill term and preterm neonates with systemic hypotension. The standard treatment for neonatal hypotension includes volume expanders and vasopressors. Recent evidence supports the use of glucocorticoids for the primary or rescue treatment of neonatal hypotension associated with impaired adrenal function. However, inconsistency regarding the prescribed dosing regimen to provide the best balance between efficacy and safety in this vulnerable population remains an area of concern. METHODS: We will conduct a systematic review and meta-analysis to evaluate low-dosing compared with high-dosing regimens of hydrocortisone for the treatment of hypotension in critically ill term, preterm and very low birth weight neonates. Ovid MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and Web of Science will be searched from inception to November 2021. Study screening and selection will be completed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Our primary outcomes will be (1) an improvement in end-organ perfusion, defined as an increase in blood pressure along with an increase in urine output or a reduction in serum lactate and (2) mortality prior to discharge. Our secondary outcomes will be the development of (1) major neurosensory abnormality, (2) bronchopulmonary dysplasia and (3) the occurrence of adverse events. DISCUSSION: Hydrocortisone may be beneficial in the treatment of hypotension associated with impaired adrenal function among critically ill neonates. However, its optimal dosing to balance desired efficacy with the risk of adverse events is yet to be determined. Our systematic review and meta-analysis aims to address this evidence gap, providing valuable knowledge for a large audience, including guideline developers, policy-makers and clinicians. PROSPERO REGISTRATION NUMBER: This protocol is submitted for registration to the international database of prospectively registered systematic reviews (PROSPERO, awaiting registration number).

Long-term safety of prenatal and neonatal exposure to paracetamol: a protocol for a systematic review.

INTRODUCTION: A surge in the use of paracetamol in neonates has resulted in growing concerns about its potential long-term adverse events. In this study, we conduct a systematic review of the long-term safety of prenatal and neonatal exposure to paracetamol in newborn infants. METHODS AND ANALYSIS: We will follow the Joanna Briggs Institute Manual for Evidence Synthesis and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements to conduct and report this review. We will conduct a systematic search of Embase, MEDLINE, Web of Science and Google Scholar for studies with data on long-term adverse events in neonates that were exposed to paracetamol in the prenatal and/or neonatal period. We will not apply language or design limitations. We will use standardised risk of bias assessment tools to perform a quality assessment of each included article. ETHICS AND DISSEMINATION: This systematic review will only involve access to publicly available data, and therefore ethical approval will not be required. The results of this study will be communicated to the target audience through peer-reviewed publication as well as other knowledge exchange platforms, such as conferences, congresses or symposia. TRIAL REGISTRATION: The protocol for this systematic review is submitted for registration to international database of prospectively registered systematic reviews (PROSPERO, awaiting registration number).