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There is growing evidence that maternal health and behaviors in pregnancy, such as pre-pregnancy obesity, excessive gestational weight gain, poor diet, smoking, and adverse pregnancy outcomes, are linked to fetal programming for obesity and cardiovascular disease (CVD) risk in the offspring. Yet, there is a surprising lack of research on the role of prenatal sedentary behavior, physical activity, and sleep (conceptualized together as 24-hour behavior) on offspring obesity risk and CVD risk; this is an unfortunate research gap since there is strong physiological rationale that these behaviors in pregnancy could influence offspring health and are modifiable intervention targets in pregnancy. This multi-site observational cohort study will leverage state-of-the-art, 24-hour behavior assessment in each trimester of pregnancy, collected as part of the Pregnancy 24/7 cohort study and add additional assessments of offspring growth, adiposity, and CVD risk through 24 months to inform future primordial prevention interventions to decrease the risk of offspring obesity and CVD across the lifespan.
The goal of this study is to determine the effectiveness of a mobile exercise app in improving cardiovascular health and motivation to exercise in pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and do not do exercise currently. The aims of this study are determine i) the effect of a mobile app (BumptUp) to increase motivation to exercise as assessed by questionnaire, and ii) the changes may occur in cardiovascular health outcomes such as increased percent Flow-Mediated Dilation (FMD), Heart Rate Variability (HRV), and decreased Pulse Wave Velocity (PWV) over an 8-week period of intervention. Researchers will compare this to pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and who will not be using the mobile app (BumptUp) for exercise. Participants who are in the experimental group will be given access to the mobile app (BumptUp) for 8 weeks. Both the control and experimental group will visit the lab for their baseline measurements (study visit 1), followed by two visits at 4 weeks (study visit 2) and 8 weeks (study visit 3) to have their heart rate variability, arterial stiffness (PWV), and vascular function (FMD) assessed. At each study visit, blood pressure, heart rate, height, and weight will also be measured. Additionally, at all three study visits, participants will fill out a questionnaire to determine motivation to exercise.
The purpose of the research is to learn whether wearing a continuous glucose monitor that shows blood glucose levels in real time on a smart phone app and participating in a group chat with other research participants will help participants keep a healthy blood glucose level during pregnancy. High levels of blood glucose during pregnancy can lead to health problems during and after pregnancy. It may also increase the risk for health problems for the developing baby. The investigators think our program might be a new way to help some people maintain a healthy blood glucose level during pregnancy. When pregnant people know their blood glucose levels are high, they can do things like exercise or drink water to bring their blood glucose levels down. They can also learn what foods to eat to maintain healthy blood glucose levels, and what foods to avoid. The investigators think being in a group chat with other pregnant individuals will allow participants to support and learn from each other. Pregnant individuals should also work with their healthcare providers to manage their blood glucose levels.
T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.
Obesity is a major risk factor for hypertensive disorders of pregnancy (HDP). The underlying mechanisms are largely unclear, but maternal vascular endothelial dysfunction is likely involved. Endothelial dysfunction in HDP could be attributed to 1) alterations in the L-arginine/nitric oxide (NO) pathway, and 2) an increase in endothelin-1 (ET-1). Additionally, augmented sympathetic vasoconstriction may also contribute to HDP. Chronic (repeated) whole-body heat exposure has been shown to increase NO bioavailability, decrease ET-1, and cause functional and structural adaptations in the vasculature. All these can improve vascular function, attenuate sympathetic (re)activity, lower blood pressure (BP), and reduce cardiovascular risk in non-pregnant individuals. Whether this is also true after regional (leg) heating in high-risk pregnant women is unknown. The investigators' central hypothesis is that chronic leg heating will be effective in improving vascular endothelial function and attenuating sympathetic vasoconstriction, leading to a reduction of the risk for HDP in pregnant women with obesity. The overarching goal of this proposal is to determine the vascular and neural effects of chronic leg heating in obese pregnancy. The study team plans to enroll pregnant women with obesity between 12-14 weeks of gestation and randomly assign them to either an intervention group or a control group (1:1 ratio). Participants in the intervention group will perform 16 weeks of home-based leg heating using a portable sauna blanket up to the hip (temperature of the blanket will be set at 65°C, 4 times/week, 45 min/session), whereas women in the control group will set the temperature of the blanket at 35°C at the same frequency and duration. Participants will be evaluated at baseline and then at 28-30 weeks of gestation. Aim 1 will determine the effects of chronic leg heating on maternal vascular function and surrogate markers of HDP. Aim 2 will determine the effects of chronic leg heating on sympathetic vasoconstriction and BP. Findings from this project will provide insight on the extent and potential mechanisms of how chronic leg heating works for improving vascular endothelial function and sympathetic vasoconstriction in pregnant women with obesity. Results obtained will set a foundation for future large multicenter clinical trials to determine the efficacy and generalizability of home-based leg heat therapy as a safe, ease-of-use, cost-effective, and non-drug approach for reducing the risk of HDP.
Data collected through the registry may be used to address a range of research questions and objectives, including but not limited to the following: Research question: Is there an increased risk of adverse maternal, fetal, or infant outcomes among individuals who are exposed to Inflammatory Bowel Disease (IBD) treatments during pregnancy? The primary objective of the registry is to estimate the prevalence of major congenital malformations among pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy. The secondary objectives of the registry are: To estimate the prevalence of other maternal, fetal, and infant outcomes among pregnant individuals with IBD who are exposed to IBD pharmacotherapies during pregnancy. To contextualize the prevalence of outcomes among pregnant individuals who are exposed to IBD pharmacotherapies during pregnancy and estimate the prevalence of all outcomes of interest among pregnant individuals with IBD who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy. If sample size permits, to estimate the risk ratio for each outcome, comparing the outcomes of pregnant individuals with IBD who are exposed to IBD pharmacotherapy with those who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy. Data collection may be used to determine pharmacotherapy-specific use with or without unexposed cohorts on an as-needed basis, as sample size allows.
This is a prospective study to evaluate if successful completion of a medication abortion in patients with very early pregnancy can be detected with a urine pregnancy test at 2 weeks instead of 4 weeks. Additionally, the resolution of pregnancy symptoms in these patients will be characterized. Enrolled participants will take take weekly pregnancy tests and complete weekly questionnaires on their pregnancy symptoms for 4 weeks after their medication abortion.
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.
Aspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. The investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. This is a Phase I/II randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. Outcomes evaluated will include the difference in aspirin response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.
Antenatal nonstress tests (NSTs) are performed to assess fetal health and are used as a cost-effective test that can be widely administered. However, an NST is operator-dependent due to the nature of Doppler ultrasound and is primarily performed in a clinic and hospital setting. The ability to conduct a clinically valuable test at home would address access to care issues faced by numerous women in the United States and reduce the workload on healthcare clinicians facing a shortage of human resources. This pilot study aims to assess the feasibility and acceptability of home NST monitoring in order to determine whether femomTM could be utilized as an adjunct to routine prenatal care. Patients with high risk pregnancies who are recommended to undergo at least once weekly at 32 weeks testing by the obstetrician will be recruited for participation in this study. Participants will be asked to perform three 30 minute monitoring sessions weekly starting at 32 weeks for 6 weeks.