Clinical Research Directory

Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women

Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow the investigators to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women's long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. The investigators hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. Participants will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that investigators develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes

Well-Mama Community Doula Navigator Study

This study will develop and test an intervention, called the Well-Mama intervention, which includes the use of a checklist by Community Doula Navigators to support pregnant women. Participants will be randomized to either receive standard perinatal care or standard perinatal care plus the Well-Mama intervention.

Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain

The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.

Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care

The purpose of the study is to rigorously evaluate Next4You, an innovative, fully mobile program featuring 6 content modules, each containing 8-10 microlessons intended to reduce rates of unintended pregnancy and sexually transmitted infections (STI) and increase essential knowledge, attitudes, and skills among young people aged 16-19 currently in the foster care system in California.

Sexual Health Education During Pregnancy

This experimental, randomized controlled, single-blind study includes intervention and control groups. Pregnant women between 16 and 20 weeks of gestation who meet the inclusion criteria and agree to participate will be included in the study. Pregnant women will be randomly assigned to groups. Pre-test data will be collected from both groups. The intervention group will receive sexual counseling training in two sessions, face-to-face and in groups, until week 22. Second test data will be collected after week 37 (before delivery), and final test data will be collected three months after delivery. This study is expected to have a significant impact on women's lives, as this topic is considered taboo in our country, leading to a lack of open discussion and the prevalence of misconceptions and false beliefs (sexual myths).

Maternal and Fetal Electrocardiograms Separation Algorithm

Effective monitoring of fetal heart activity during the second and third trimesters remains a vital challenge in perinatal medicine. This study proposes an adaptive algorithm for extracting the fetal electrocardiograms signal from abdominal ECG in pregnant women, considering the physiological characteristics of each trimester. Utilizing modern machine learning methods, independent component analysis, and data from wearable textile electrodes. The goal is to enhance the accuracy and reliability of automatic signal separation. A dataset of 300 recordings will be collected and analyzed. The resulting algorithm will enable rapid and precise detection of fetal heartbeats. To validate the algorithm, 50 patients will be recruited separately.

Maternal & Offspring Microbiome Study

The purpose of the study is to learn how different dietary interventions affect microbiota diversity in pregnant women and the transmission of microbiota to their infants during pregnancy, birth, and postpartum.

Longitudinal Study of Gene Expression in the Human Placenta During First-trimester and Full-term Pregnancy at the Single Cell Level

The single nucleus RNA-seq approach allows the placental transcriptome to be analyzed from nuclei, thus preserving the integrity of placental syncytium. This approach is feasible on small fragments of villi and offers for the first time the possibility to consider the characterization of gene expression within the structural unit of the human placenta during pregnancy (at the 1st trimester and childbirth)

Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first. This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, and Albireo pharmacovigilance. Study start date is either start of data collection or first patient enrolled whatever occurs earlier. The surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this surveillance program.

Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe

The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.

Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States

IMPAACT 2046/UPLIFT (Understanding Practices of Lactation and Infant Feeding decisions Together with women with HIV) is a multi-site, mixed-methods, observational cohort study. The purpose of the study is to explore infant feeding preferences, practices, and outcomes among mothers with HIV and their families in the United States. It will employ both qualitative and quantitative research methods to address existing knowledge gaps and to understand the clinical, behavioral, and social factors influencing infant feeding decisions. As part of the study's mixed method approach, a longitudinal cohort study of mothers and their infants will be established. The study also aims to pilot a national registry of breastfeeding women living with HIV in the United States.

Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy

This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.

Pregnancy Registry in Mali

This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.

Perineal Massage Using A Pelvic Wand During Pregnancy

There is limited research on the optimal strategy to reduce obstetric laceration, postpartum urinary retention, and postpartum pelvic pain. In systematic reviews, clinician-directed massage of the perineal muscles at the time of birth and patient directed massage of the perineal muscles in the third trimester to inconsistently reduce the incidence of severe obstetric laceration.1,2 However, there is significant heterogeneity of these studies is due in large part to the lack of a standardized protocols and unpredictability of clinician availability to perform perineal massage around the time of birth. The purpose of this study is to understand how perineal massage with a pelvic wand in late pregnancy and during labor influences one's sense of self-control over the labor process and birth experience.

Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery

One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide. A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.

Mobile Application-based Exercise Intervention for Pregnant Women

The overarching goal of this randomized controlled clinical trial is to test the efficacy of the mHealth app (BumptUp) for improving physical activity levels among pregnant and postpartum women in a rural setting. Secondary outcomes include weight status, dietary intake, glucose tolerance, blood pressure, and mental health. Specific Aim 1. Conduct an RCT (N=176) to assess the efficacy of the mHealth intervention for increasing physical activity levels during pregnancy (13-15, 23-25, and 35-37 weeks gestation) and postpartum (6 and 12 weeks) among women in a rural setting. Research Activities: The efficacy of BumptUp® will be determined by measuring physical activity levels (via accelerometry and surveys) between women who use the mobile app (intervention) and women who use only an educational brochure (attention control). Specific Aim 2: Assess the efficacy of the mHealth intervention on important obstetric outcomes including maternal weight status, dietary intake, glucose tolerance, blood pressure, and mental health. Research Activities: Maternal weight status, glucose tolerance, and blood pressure values will be obtained from patient charts. Dietary intake will be assessed via the National Cancer Institute Multifactor Screener. Maternal mental health status will be measured via The Edinberg Postpartum Depression Questionnaire, Center for Epidemiological Studies Depression Scale, and the State-Trait Anxiety Inventory.

Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

The goal of this study is to determine if there is a positive effect of prophylactic red blood cell (RBC) transfusion of leukoreduced, ABO, Rh (D/Cc/Ee) and Kell matched blood compared to standard of care on the number of episodes of acute sickle cell disease (SCD) manifestations or pregnancy-related complications requiring acute health care encounters (acute care/ER/Hospital visits) or resulting in death over the entirety of pregnancy until 2 months post-partum in women with SCD. RBC transfusion is the only disease-modifying therapy for pregnant women with SCD, and it is considered a standard treatment option however, there exists no consensus on the role of transfusion therapy in preventing SCD-related pregnancy complications. Participants will be randomly assigned to repeated red blood cell transfusions or the standard of care. Participants will be on study for about 8-10 months (Pregnancy through 2 months post-partum).

Cardiovascular Research in EMbarazo and MAternity (EMMA). Study on Heart Rate Variability and Hemodynamic Adaptations During Pregnancy and Postpartum.

Heart rate variability (HRV) provides a non-invasive assessment of autonomic control of the nervous system over the heart. During pregnancy, the cardiovascular system adapts significantly, affecting HRV and hemodynamics. Studying the relationship between HRV and hemodynamic changes is critical to understanding and monitoring cardiovascular health during pregnancy and postpartum, and predicting potential complications.

Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period

This is a study to determine the effect of a novel patient-centered, reproductive planning decision support tool developed by the research team called MyPath on postpartum contraceptive decision-making among women with SUDs.

Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables

Congenital heart disease (CHD) includes a wide variety of types of disease, including congenital abnormalities of the heart valves. This can range from bicuspid aortic valve and other aortic valve deformities to more complex disease such as tetralogy of Fallot. For many kinds of CHD, the optimal timing of interventions remains unclear. For instance, in tetralogy of Fallot, there is still equipoise about when to offer pulmonary valve replacement (PVR), while in aortic regurgitation, some patients can remain stable for many years. The primary focus of this study is to use continuous physiologic data (CPD), obtained using wearable biosensors (a type of biometric monitoring technology), to develop improved biomarkers of disease progression and prognosis from patients with congenital heart disease (CHD) who are pregnant while they are at home as well as looking at patients' experience and interaction with wearable biosensor technology at home.

Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron.

Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

This is an open-label individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.

Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme

To implement an effective but low-cost strategy to decrease SCD maternal and perinatal mortality in Ghana. The objectives are to 1) assess the impact of a multidisciplinary SCD-obstetric team for decreasing mortality across three hospital sites in Ghana. 2) assess the implementation fidelity for 2a) preventing and 2b) treating acute chest syndrome in pregnant women with SCD admitted to the hospital. 3) standardize an ultrasound protocol for the prospective monitoring of fetal growth among pregnant women with SCD.

Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy

This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.