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Clinical Trials: Women’s Health (Infertility, Menopause, Etc.)
IRB No. 22-327-1 (Dr. Biree Andemariam, PI): Bone Loss, Physical Function and Frailty in Older Women with Sickle Cell Trait
This research study has two purposes. The first purpose is to determine whether having sickle cell trait is a risk factor for the development of bone thinning in older women. Nearly 10% of African Americans carry sickle cell trait, and most of them are unaware of it. African Americans are less likely to develop thin bones than whites, but if they sustain a bone fracture, they are more likely to die from it. Having sickle cell trait may lead to bone thinning and predispose a subset of African Americans to dangerously thin bones. The second purpose is to investigate whether women with SCT have reduced decreased muscle function, decreased muscle mass, and increased frailty compared to women without SCT. Frailty is a common clinical syndrome in older adults that carries an increased risk for poor health outcomes, including falls, incident disability, hospitalization, and death. This study will try to fill a knowledge gap in the scientific literature. It may potentially reveal a previously unrecognized risk factor for disability and address potential health disparity in African descent women.
IRB No. 23-113-2 (Dr. Andrea Shields, PI): Assessing postpartum volume status using clinical, laboratory, and sonographic values in a cohort of normotensive versus preeclamptic women
The hypothesis of this study is that ultrasound measurements of vein diameter will correlate to clinical and laboratory based values that measure the amount of fluid in a person's circulation and body; we will specifically look at women who are postpartum in two groups -- women with no high blood pressure and women with preeclampsia. Our aims will be to: - Measure the diameter of the inferior vena cava with a portable ultrasound - Examine the patient and look for signs of volume status (i.e. swelling in the legs) - Perform routine labatory tests that will reflect the amount of circulating blood volume (brain natriuretic peptide) Our objectives will be to: - Examine whether the vein diameter correlated with the level of brain natriuretic peptide - Examine whether there are differences in all values collected between the no high blood pressurs vs. preeclampsia population - In the preeclamptic population, collect 2-3 days of data so changes that occur longitudinally can also be examined.
IRB No. 23-190S-2 (Dr. Andrea Shields, PI): Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes
Gestational Diabetes Mellitus (GDM) affects 2-10% of pregnancies in the US and 50% of GDM patients will progress to develop Type II Diabetes Mellitusin their lifetime. GDM can also cause pregnancy complications including antepartum hospitalization, cesarean delivery and longer length of stay during antepartum or delivery admissions. Improving pregnancy outcomes involves patients understanding and adopting to an ADA specific diet, daily glucose monitoring and physical activity and compliance with prenatal visits. Providing education during pregnancy is the optimal window of opportunity for the prevention of diabetes. In Phase 1 of the study, the team of investigators will develop a novel, personalized lifestyle intervention (Meals 4 Moms Bundle) for pregnant patients diagnosed with GDM to supplement the usual care and education that is provided to such patients. The bundle will include additional GDM education, nutrition and exericse guidance, GDM meal kit delivery and support. Prior to implementation of the bundle, focus groups (with current GDM patients) to solicit feedback on the bundle materials will be conducted. Phase 2 of the study will involve a pilot feasibility randomized clinical trial which includes UConn Health patients diagnosed with GDM. Patients will be randomly assigned to receive usual obstetrics care for patients who are diagnosed with GDM or usual care plus the Meals 4 Mom Bundle. The clinical trial will assess the feasibility and acceptability outcomes of recruitment rate, retention, adherence to diet and exercise recommendations and acceptability with the program.
IRB No. 23-179-1 (Dr. Andrea Shields, PI): Xenobiotic transfer of Tranexamic acid (TXA) using an ex vivo placental perfusion model: a pilot study
To our knowledge, there are no studies that have researched if tranexamic acid (TXA) has an effect on the placenta, or if there is considerable transfer of the drug from maternal to fetal circulation. We propose studying the transfer of the drug on a single placental lobule of 7 placentas. We hypothesize that given the large molecular composition of tranexamic acid there will be minimal transfer of the drug in the ex-vivo placental perfusion model, thus providing safety data on the administration of tranexamic acid for therapeutic indications especially during pregnancy. The specific aims are: 1) To set up and troubleshoot the placental perfusion model using 3-5 placental lobules 2) To measure and compare the levels of therapeutic tranexamic acid in the maternal versus fetal perfusate collected from an ex-vivo placental perfusion model.