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.

The Use of Photobiomodulation for Pain and Healing in Cesarean Section

Good incisional wound healing and postoperative pain are the primary concerns regarding cesarean delivery, as it can lead to serious complications and delayed recovery for patients. Both pharmacological and non-pharmacological interventions have been investigated to promote effective analgesia and favorable healing of the cesarean surgical incision. Among the therapies under investigation for this purpose, photobiomodulation (PBM) stands out. Photobiomodulation consists of the use of low-intensity therapeutic light, and several publications have emphasized its analgesic properties and its capacity to promote wound healing across various etiologies. This study aims to evaluate the analgesic and wound-healing effects of PBM on the skin surgical incision following cesarean section. This will be a randomized controlled clinical trial in which 30 women undergoing elective cesarean delivery will be randomly allocated into two groups: a control group or a photobiomodulation group. All participants will receive standard hospital treatment for analgesia and postoperative wound care, combined with an active PBM protocol consisting of 3 J per point (658 nm) applied to the incisional area and 4.5 J per point (830 nm) applied around the wound, delivered immediately postoperatively, as well as 24 and 48 hours after surgery. The control group will undergo PBM with the laser device turned off, using the same protocol. Patients will be assessed before and after each PBM session, at 24 and 48 hours, and at 5, 10, and 40 days postpartum, to evaluate pain intensity using the Visual Analog Scale (VAS) and the McGill Pain Questionnaire, as well as wound healing using the REEDA scale. Clinical wound characteristics, epidemiological data, analgesic consumption during the inpatient period, and the occurrence of adverse events will be used as secondary outcomes. A two-way repeated-measures ANOVA will be used for comparisons between groups and across time points.

Effects Of Multimodal Physical Therapy Intervention On Musculoskeletal Function And Low Back Pain In Postpartum Women

Postpartum low back pain is a common musculoskeletal problem that affects women's functional ability, childcare activities, and quality of life after childbirth. Hormonal, biomechanical, and muscular changes during pregnancy and the postpartum period, including reduced core stability and pelvic floor weakness, contribute to persistent lumbopelvic pain and disability. In Pakistan, awareness and access to postpartum physiotherapy rehabilitation remain limited despite the high prevalence of postpartum low back pain. Evidence suggests that multimodal physiotherapy interventions, including core stabilization exercises, pelvic floor training, manual therapy, ergonomic advice, and patient education, can effectively reduce pain and improve functional outcomes in postpartum women. However, limited randomized controlled trials have been conducted in Pakistan to evaluate these interventions. The aim of this study is to determine the effects of a multimodal physical therapy intervention on low back pain, musculoskeletal function, core endurance, fatigue, and quality of life in postpartum women. This study will be conducted as a single-blinded, two-arm parallel randomized controlled trial at Ayub Medical Complex Abbottabad and CMH Abbottabad. A total of 40 postpartum women aged 20-40 years with low back pain within six months after delivery will be recruited and randomly allocated into experimental and control groups. The experimental group will receive a six-week multimodal physiotherapy program consisting of core stabilization exercises, pelvic floor muscle training, manual therapy, posture correction, ergonomic education, and home exercise guidance. The control group will receive routine postpartum care only. Outcome measures will include the Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), core endurance tests, SF-36 Quality of Life Questionnaire, and PROMIS® Fatigue Short Form. Assessments will be conducted at baseline, post-intervention, and follow-up. Data will be analyzed using SPSS version 29 with appropriate statistical tests for within-group and between-group comparisons. Ethical approval and informed consent procedures will be ensured before data collection. This study is expected to provide evidence regarding the effectiveness of multimodal physiotherapy in improving pain, function, and quality of life among postpartum women and may support the integration of physiotherapy into routine maternal healthcare services in Pakistan.

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.

Additional Effects of Mulligan Mobilization With Movement Along With Core Strengthening Exercises in Postpartum Females With Sacroiliac Joint Dysfunction

This study aims to evaluate the combined effectiveness of Mulligan mobilization and core strengthening exercises in managing postpartum sacroiliac joint dysfunction (SIJD). Postpartum SIJD is a common condition resulting from biomechanical and hormonal changes during pregnancy, often leading to pelvic instability and pain. Mulligan mobilization, a manual therapy technique, aims to correct joint alignment and restore pain-free movement. For the SIJ, Mulligan MWM aims to correct subtle positional faults or movement restrictions that may cause pain and dysfunction-especially common postpartum due to ligamentous laxity, hormonal changes, and altered biomechanics.The core muscles provide stability to the pelvis and lumbar spine. When these muscles are weak or imbalanced, it can lead to increased strain on the SIJ, contributing to pain and dysfunction. Strengthening the core improves load transfer through the pelvis and enhances neuromuscular control, thereby reducing SIJ stress and symptoms. Core strengthening exercises enhances outcomes by targeting both mechanical alignment and muscular stability. Core strengthening exercises target muscles that support pelvic stability, including the transverse abdominis and pelvic floor. The study hypothesizes that integrating Mulligan mobilization with core strengthening may provide superior outcomes in pain reduction, joint function, and overall quality of life compared to core exercises alone.

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.