Clinical Research Directory

Deconstructing Maternal Burdens: Doulas and the Community Unite for Health

This study is a randomized controlled trial comparing two models of doula support for pregnant individuals enrolled in Medicaid: an enhanced doula support model, in which support starts earlier in pregnancy, occurs more frequently, and continues through the first year after birth, versus the standard doula care currently covered by Medicaid in Florida. The study also builds the doula workforce needed to sustain this model of care, training doulas to become eligible to bill Medicaid for their services. The primary goal is to determine whether the enhanced doula model results in significantly lower rates of perinatal depressive and anxiety symptoms compared to standard doula support, while gathering data on real-world implementation. The study also evaluates the effectiveness of Medicaid-covered doula services more broadly, with findings intended to inform state-level policy on Medicaid reimbursement and the extension of doula services into the postpartum period.

Gestational Changes in Hemodynamics and Respiratory Mechanics in Association With Pre-Eclampsia

This study focuses on elucidating the changes of hemodynamics assessed by USCOM and respiratory mechanics assessed by impedance oscillometry (IOS) over the course of pregnancy and the postpartum period. Additionally, to understand how these changes over the course of gestation relate to the development of preeclampsia.

Pelviperineal Physiotherapy in Postpartum

Objective: To compare the effectiveness of pelviperineal physiotherapy hypopressive exercise, and pelvic health education for the prevention and treatment of postpartum pelvic floor dysfunction in primiparous women after vaginal delivery.

Pilot Feasibility Study With Doulas

The purpose of this study is to determine whether an existing evidence-based intervention, You Matter, can be delivered with fidelity by doulas at their community clinic, MAAME, Inc.

Family Centred Healthcare - Zero Separation and Couplet Care

Today mother and infant are routinely separated directly after birth if there is a need of specialised treatment and care, despite of the significant and positive effects of skin-to-skin contact. Thus, there is a need of change in organizing the treatment and care in a way that minimizes separation. The aim is to evaluate the implementation and effect of a complex family-centred intervention based 107 on zero separation and couplet care. The intervention is rooted in the philosophy of family-centred care. Essentially, mother infant dyads will be admitted together, where they will receive couplet care by neonatal nurses. The study comprises a quasi-experimental trial and a qualitative process evaluation including a field study and two interview studies. Finally, a health economic evaluation will be conducted to assess the cost-effectiveness of this complex intervention. The intervention will take place at the Neonatal Intensive Care Unit at Hvidovre Hospital. The nurses will as a part of the intervention be educated to take care of both mother and infant and carry out the intervention. Five families with experiences from the Neonatal Intensive Care Unit and the Maternity Unit participates as patient and public representative in the project, as their experiences and ideas will provide an added value to the project. This study contribute with a new perspective on how to organize the treatment and care of a newborn family in a Neonatal Intensive Care Unit. The study will be the first to examine zero separation and couplet care within sick mother-infant dyads. The study will provide knowledge about how an intervention consisting of zero separation and couplet care can be feasible and acceptable, and what kind of effect and impact it will provide. It is expected that the study as a whole may impact and profile clinical nursing, as well as benefitting public health.