Clinical Research Directory

Partnering With Antenatal Navigators to Transform Health in Pregnancy

The Partnering with Antenatal Navigators to Transform Health in Pregnancy (PATH) study aims to evaluate whether an antenatal patient navigation program improves maternal health, neonatal health, pregnant women's experiences, and health care utilization outcomes among low-income pregnant women and their neonates. Patient navigation is an individualized, barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services. In this randomized controlled trial, pregnant women who are randomized to receive antenatal patient navigation will be compared to pregnant women who are randomized to receive usual care. Navigators will support pregnant women from before 20 weeks of gestation through 2 weeks postpartum. The PATH intervention will be grounded in understanding and addressing factors that influence health and access to care in order to promote self-efficacy, enhance access, and sustain long-term engagement. The main objectives of the study are to: 1. Evaluate whether PATH, compared to usual care, improves maternal health outcomes. We hypothesize the PATH model of antenatal patient navigation for low-income women will reduce the incidence of a composite of adverse maternal outcomes, all of which are known to be increased among women with barriers to care. 2. Evaluate whether PATH, compared to usual care, improves perinatal health outcomes. We hypothesize PATH will reduce the incidence of a composite of adverse perinatal outcomes. We will also investigate neonatal/pediatric health care utilization. 3. Evaluate patient, clinician, navigator, and healthcare system experiences with PATH in preparation for widespread implementation and dissemination of the PATH obstetric navigation model. This aim will be accomplished through investigating patient-reported outcomes, completing qualitative and process mapping interviews with navigated participants, and completing qualitative and process mapping interviews with clinicians, navigators, and health administrators.

Shifting Options Study

The goal of Shifting Options is to create strategies and resources that will facilitate informed decision-making about prenatal screening and diagnostic testing (PS\&D) for all pregnant patients. Shifting Options will determine how rapid changes in PS\&D and post-diagnosis options affect the nature and timing of resources and support patients need to make informed PS\&D decisions. To achieve this goal, patient participants will be interviewed to identify their PS\&D decision-making needs. Then, clinician participants input will be added on how best to implement strategies that address those needs.

Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities

The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are: * Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy? * Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy? * Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term? Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term. Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care. All participants will be asked to: * complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device. * complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit. People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as: * a stress reduction toolkit; * access to an online website that can also be downloaded as a smart phone app; * the option to receive an electronic massage while in clinic, and more. * additional support gifts provided at routine clinical appointments People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.

Utilization of Maternal Healthcare Services and Infant Feeding Practices

The goal of this observational study is to assess household food insecurity among slum-dwelling women in India and to explore if household food insecurity is associated with maternal healthcare services utilization and infant feeding practices The main questions it aims to answer are: 1. Is the utilization of maternal healthcare services antenatally, during delivery, and postnatally associated with household food insecurity among slum-dwelling women in Pune, India? 2. Is household food insecurity associated with birth outcomes and infant growth in these women? Participants will be asked: 1. For information related to socio-demographic characteristics, healthcare services utilization, food insecurity experience, dietary intake, and infant feeding indicators using a questionnaire. 2. Anthropometric measurements of the participant, her husband and her infant/s will be collected. 3. Focus group discussions (FGDs) will also be conducted to gain insight into the perceptions of these women with respect to the utilization of maternal healthcare services.

The Effect of Laughter Yoga and Pilates on Pregnancy in Pregnant Women Receiving Childbirth Preparation Training

The aim of the study was to determine the effect of laughter yoga and pilates on pregnancy adjustment, anxiety and prenatal attachment in pregnant women who received childbirth preparation training.

Determine the Clinical Effectiveness of Mobile CenteringPregnancy to Improve Maternal and Infant Health Outcomes of Marshallese in Arkansas

Pacific Islanders bear a disproportionate burden of obesity compared to other racial/ethnic minorities and the United States (US) population. Pacific Islanders residing in the US also have high maternal and infant health disparities with disproportionally high rates of preterm birth (\<37 weeks) and low birthweight infants (\<2,500 grams). They are also more likely to experience preeclampsia, primary cesarean birth, excessive gestational weight gain, gestational diabetes mellitus, and low exclusive breastfeeding rates compared to other racial/ethnic minorities and the US population in general. These unique health circumstances increase medical complications and are associated with impaired glucose intolerance, delivery complications, and higher incidence of obesity and metabolic disease risk later in life for infants. Early and consistent supportive care throughout the pregnancy continuum is strongly associated with positive birth outcomes that can mitigate childhood obesity. However, Pacific Islanders are less likely to receive adequate prenatal care compared to other racial and/or ethnic minorities. Our preliminary studies using Arkansas birth records (n=2,488; 2019) have shown that Marshallese experience exceptionally poor perinatal outcomes, even compared to other US Pacific Islanders. Specifically, 15% of Marshallese women received no prenatal care (compared to 1.6% women nationally); more than 50% do not attend the recommended number of prenatal care visits; 19% of Marshallese infants were born preterm (compared to 9.6% nationally); and 15% of Marshallese infants were low birthweight (compared to 8.3% nationally). These poor health outcomes are highly associated with childhood obesity risk through increased odds of rapid infant weight gain and sub-optimal infant feeding practices. Thus, our foundational work demonstrates an urgent need for culturally adapted interventions to engage the Marshallese community in Arkansas in prenatal care that optimize birth outcomes that can mitigate childhood obesity. CenteringPregnancy, an evidenced-based group prenatal care model, challenges the standard model of one- on-one prenatal counseling and has demonstrated effectiveness in other populations in lowering the risk of preterm birth, low birthweight infants, and increasing exclusive breastfeeding initiation compared to women receiving individualized care. Our prior work has demonstrated how challenging delivering group care is to the Marshallese community because of transportation barriers. Mobile health clinics are transforming the US healthcare system by delivering services directly to communities of need. However, mobile health clinics have not yet been implemented with group prenatal programs like CenteringPregnancy in the US. The proposed study will determine the preliminary effectiveness of an innovative Mobile CenteringPregnancy program for Marshallese women while also evaluating implementation determinants and outcomes to inform sustainable scaling of the program.

Impact of Food Insecurity on Utilization of Maternal Healthcare Services and Birth Outcomes in Slums in Pune, India

The goal of this observational study is to assess household food insecurity among slum-dwelling women in India and to explore if household food insecurity is associated with utilization of maternal healthcare services, birth outcomes and infant growth. The main questions it aims to answer are: * Is the utilization of maternal healthcare services antenatally, during delivery, and postnatally associated with household food insecurity among slum-dwelling women in Pune, India? * Is household food insecurity associated with birth outcomes and infant growth in these women? Participants will be asked: * For information related to socio-demographic characteristics, healthcare services utilization, food insecurity experience, dietary intake, and infant feeding indicators using a questionnaire. * Anthropometric measurements of the participant, her husband and her infant/s will be collected. * Two focused group discussions (FGDs) will also be conducted to gain insight into the perceptions of these women with respect to the utilization of maternal healthcare services. One FGD will be conducted for women who availed all the healthcare services and the other for those who did not adequately avail of the antenatal and postnatal services.