GAP (gestational diabetes and pharmacotherapy) - study protocol for a randomized controlled, two-arm, single-site trial.

BACKGROUND: Gestational diabetes (GDM) complicates 10% of pregnancies in the US. First-line treatment is medical nutrition therapy (MNT) and exercise. Second line is pharmacotherapy. The definition of what constitutes an unsuccessful trial of MNT and exercise has not been established. Tight glycemic control has been demonstrated to reduce GDM-related neonatal and maternal clinical complications. However, it could also increase rates of small-for-gestational age and carry negative effects on patient-reported outcomes such as anxiety and stress. We will study the effect of earlier and stricter pharmacotherapy in GDM on clinical and patient-reported outcomes. METHODS: GDM and pharmacotherapy (GAP) study is a two-arm parallel, pragmatic randomized controlled trial, where 416 participants with GDM are randomized 1:1 to: 1) Intervention group - insulin initiation at 20% elevated glucose values on a weekly glucose log following MNT and exercise trial and insulin titration to keep elevated glucose values <20%; or 2) Active control group - insulin initiation at 40% elevated glucose values on a weekly log following MNT and exercise and insulin titration to keep elevated glucose values <40%. The primary outcome is a composite neonatal outcome of large-for-gestational-age, macrosomia, birth trauma, preterm birth, hypoglycemia, and hyperbilirubinemia. Secondary outcomes include preeclampsia, cesarean birth, small-for-gestational-age, maternal hypoglycemia, and patient-reported outcomes of anxiety, depression, perceived stress, and diabetes self-efficacy. CONCLUSIONS: The GAP study will investigate the optimal glycemic threshold for pharmacotherapy addition to MNT and exercise in GDM. The GAP study will promote standardization in GDM management and will have direct relevance for clinical practice.

Differing perspectives on parent access to their child's electronic medical record during neonatal intensive care hospitalization: a pilot study.

OBJECTIVE: To improve informed medical decision-making, principles for family-centered neonatal care recommend that parents have access to their child's medical record on an ongoing basis during neonatal intensive unit care (NICU) hospitalization. Currently, many NICUs do not allow independent parent access to their child's electronic medical record (EMR) during hospitalization. We undertook a cross-sectional survey pilot study of medical professionals and parents to explore opinions regarding this practice. STUDY DESIGN: Inclusion criteria: 18-years old, English-literate, legal guardian of patients admitted to the NICU for 14 days. NICU medical professionals included physicians, nurse practitioners, nurses, and respiratory therapists. RESULT: Medical professionals believed parent access would make their work more difficult, increase time documenting and updating families, making them more liable to litigation and hesitant to chart sensitive information. However, parents felt that they lacked control over their child's care and desired direct access to the EMR. Parents believed this would improve accuracy of their child's medical chart, and increase advocacy and understanding of their child's illness. CONCLUSION: NICU parents and medical professionals have differing perspectives on independent parental access to their child's EMR. More research is needed to explore the potential of independent parental EMR access to further improve family-centered neonatal care.

Supplemental written information improves prenatal counseling: a randomized trial.

OBJECTIVE: To determine if maternal knowledge of prematurity is improved when verbal gestational age-specific counseling is supplemented with written gestational age-specific information. METHODS: Prospective, randomized study of 60 pregnant participants assessed to be at risk for premature delivery between 23 and 34 weeks' gestation. Counseling in the control group consisted of gestational age-specific verbal information, and counseling in the intervention group consisted of written gestational age-specific information 1 hour before the verbal gestational age-specific information. Both groups completed a Prematurity Knowledge Questionnaire after counseling and the State-Trait Anxiety Inventory before and after counseling. The Prematurity Knowledge Questionnaire consisted of questions regarding short-term problems (immature lungs, intraventricular hemorrhage, retinopathy, feeding problems, infection, apnea, and jaundice), long-term problems (chronic lung disease, postdischarge respiratory infections, visual impairment, hearing impairment, brain damage, and learning and behavior problems), and numerical outcome data (probabilities of survival, survival without significant morbidity, severe intraventricular hemorrhage, severe retinopathy, and chronic lung disease). RESULTS: Knowledge of short-term problems was not statistically different between the intervention (82%) and control groups (67%). Knowledge of long-term problems was better in the intervention (71%) than the control group (45%). Knowledge of numerical data was better in the intervention (48%) than the control group (29%). State-Trait Anxiety Inventory scores decreased after counseling in the intervention group. CONCLUSIONS: Supplementation of face-to-face verbal counseling with written information improved knowledge of long-term problems and knowledge of numerical outcome data, and it also decreased anxiety in women expecting a premature delivery.