72 Clinical Trials for Various Conditions
The study aims to build on the knowledge of the United States' ongoing maternal health crisis for Black birthing people. The study team will take a holistic focused approach to build on the experiences of Black women perinatal nurses, Black women/birthing people, and their care partners enrolled in the Holistic Care Partner Program (HCP) to understand the program's feasibility and acceptability. HCP was developed at NYU Langone Health by Blank women-led perinatal nurses to address the effects of obstetric racism and the associated fear of pregnancy and birth faced by Black women and birthing people. Utilizing a mixed-methods approach, the study will focus on understanding HCP's acceptability and feasibility via surveys and qualitative interviews with Black women and birthing people and their partners/support persons to identify strategies and recommendations for intervention improvement. Exploratory analysis of maternal and infant outcomes will be conducted using a propensity score matched historical control group.
During the first two years of the COVID-19 pandemic, the City of Chelsea, Massachusetts held a lottery to allocate cash benefits to its residents for ten months. Using data from the Chelsea Eats program, the investigators propose to study the impact of the cash benefit on reproductive and perinatal health.
Low income mothers of young children represent a disadvantaged group who are at exceptional risk for depressive syndromes and who have increasingly limited access to mental health services. The proposed project is designed to evaluate Mom-Net, an internet-facilitated cognitive-behavioral(CBT) intervention for depression, adapted from Lewinsohn's Coping with Depression Course, and tailored to mothers of young children. Mom-Net, which was developed and piloted in an recently completed NIMH-funded investigation (MH070426), was designed to overcome the substantial barriers to treatment participation that exist for mothers experiencing economic hardship and those in rural communities. Though the pilot trial demonstrated that the program was very effective in reducing depressive symptoms and related difficulties, it was conducted under the 'idealized' conditions typical of initial intervention tests (e.g., computers and internet connections were supplied to all participants; access to the internet was provided by a single browser; coaches who provided weekly phone support were research staff, and initial recruitment and motivational interviews sessions were conducted via home visits to participants). These conditions likely facilitated recruitment and retention of participants, as well as ease and fidelity of treatment delivery. Thus one goal of the current project is to evaluate the intervention under conditions that are closer to those of real-world service providers and recipients. The current project is also intended to provide a more rigorous test of the intervention than did the pilot in a number of ways. Participants in the pilot trial will be 300 mothers of 3-5 year old children recruited through Head Start classrooms and prescreened for the presence of elevated depressive symptoms.Subsequent to the pre-intervention assessment, participants will be randomized to either the intervention or facilitated usual care (FUC) condition. The evaluation of the intervention will focus on maternal depressive symptoms, parenting behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month intervals) will enable us to examine maintenance of effects. Overall, the investigation will contribute to the evidentiary base regarding the dissemination potential of this empirically-supported intervention, adaptations to which have the potential to enable a greater proportion of the population to access and benefit from it.
The proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.
This pilot randomized controlled trial will evaluate the feasibility and effectiveness of a mobile neurofeedback intervention for increasing maternal overall well-being, and measuring whether mothers experience any subsequent reductions in trauma symptoms and parenting stress and enhancements in regard to emotional regulation, parenting sensitivity and positive parenting behaviors, as well as infant socio-emotional development and behavioral outcomes (i.e., crying, fussing) among postpartum mothers with symptoms of post-traumatic stress disorder. The investigators hypothesize that mothers who receive the neurofeedback intervention will demonstrate larger decreases in mental health symptoms, greater improvements in emotional regulation and observed parenting behaviors, increased feelings of parenting competency, decreased feelings of parenting stress, and reductions in the potential for child maltreatment than mothers in the control group. The investigators also hypothesize that infants of mothers who receive the neurofeedback intervention will demonstrate less crying and fussiness and higher scores on socio-emotional developmental assessments than infants of mothers in the control group at the posttest interval.
This study is being conducted to determine if a multi-level intervention for delivering maternity care can improve patient trust and engagement among Black birthing people.
The ZTWINS registry study is an observational, prospective, multi-center study observing women carrying a twin pregnancy who receive snp-based non-invasive prenatal screening and zygosity assessment as part of their medical care.
See https://studypages.com/s/healthy-moms-study-765273 This individual-level randomized trial involves pregnant women followed for at least 6 months after delivery, to compare the effects of providing two "attention-control" counseling interventions designed to increase pregnant women's awareness of either: 1. the maternal health benefits of breastfeeding, or 2. the health benefits of smoke-free homes
The number of women who are incarcerated in the U.S. has increased dramatically over the past 20 years-over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas incarcerates 92 women per 100,000 population compared to 57 per 100,000 average across all states, ranking the state as the 8th highest in the nation. Over 75% of incarcerated women are of childbearing age and about 4% are pregnant upon intake. However, little is known about the population of women who have become incarcerated while pregnant in Arkansas - including the outcomes of these women and their children and how these outcomes may vary in relation to services that are received during incarceration. This research study aims to first expand knowledge on incarcerated women in Arkansas by using administrative data to retrospectively examine the health status and outcomes of pregnant women who were incarcerated in state prison by Arkansas from June 1, 2014 to May 31, 2019 (a five-year cohort; Aim 1). Then, we will lay the groundwork for and subsequently analyze data on outcomes and perspectives of women who have been incarcerated in Arkansas while pregnant (Aims 2 and 3). We will also seek to understand the feasibility and acceptability of elements of an enhanced support program for incarcerated pregnant women recently launched via a collaboration between Arkansas Department of Corrections and UAMS.
Mothers with symptoms suggesting clinical depression can be identified and potentially motivated to seek further care during pediatric visits for their young children. The best ways for pediatric providers to encourage mothers to seek further evaluation and treatment for their depressive symptoms are not known. The investigators plan to provisionally optimize a pediatric office-based intervention that the investigators developed to motivate mothers who may be depressed to seek further care and, thereby to improve the well-being of women from diverse backgrounds and their children.
This study aims to determine whether or not spinal anesthesia with the local anesthetic drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in faster discharge from the post-anesthesia care unit after surgery.
The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.
This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. The biological specimens will be used to determine the predictive power of biochemical markers routinely used in Down syndrome screening in the assessment of patient's risk of preterm delivery.
This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal sensory stimulation can influence physical growth, brain maturation, respiratory stability and early vocalization during postnatal development. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental in premature infants and will increase their potential to grow into healthy children.
Because adherence to postnatal care guidelines across the United States (U.S.) is poor, newborns and mothers often are placed at undue risk for adverse medical and social outcomes. This study aims to evaluate an alternative model of care and improve healthcare delivery to and reduce health disparities for "well" newborns and mothers after hospital discharge by using single postnatal home nurse visits. The principal investigator has previously shown a reduction in poor outcomes for infants who receive a home visit after discharge when studied retrospectively. The proposed research will build on the previous study and prospectively evaluate the impact of a single home nursing visit on morbidities and health disparities for newborns and mothers in a randomized, controlled trial involving 1154 mother/infant breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk period of infancy and motherhood, where medical and social problems can be recognized, anticipated, and/or treated, and can bridge the gap between hospital care and primary care. The investigators' program, The Nurses for Infants Through Teaching and Assessment after the NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation compared with guidelines-adherent outpatient clinic care.
The purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality.
The purpose of this study is to address the gap in maternal OUD treatment and infant neonatal opioid withdrawal syndrome care. The research team will develop a treatment model and a set of strategies to provide evidence-based OUD treatment to postpartum mothers in NICUs. First, the investigators will conduct a needs assessment via in-depth qualitative interviews with NICU mothers and clinicians. Then, with the expertise of the advisory board, the the researchers will create a protocol for implementing maternal OUD treatment at the NICU bedside. The researchers will then implement the protocol in two partner NICUs and evaluate the acceptability and feasibility to patients, providers, and clinical, and administrative leaders. The goal of this research study is to integrate maternal mental health and substance abuse treatment in pediatric settings and to refine, test, and examine the acceptability and feasibility of applying the adapted model.
Alive \& Thrive (A\&T) is an initiative that supports the scaling up of nutrition interventions to save lives, prevent illnesses, and contribute to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding practices. In Burkina Faso, A\&T developed an intensive package of maternal nutrition interventions to be integrated into existing ANC services delivered through government health facilities that align with the latest global evidence. These included intensified counseling and support on dietary diversity and quality during pregnancy, iron-folic acid (IFA) supplements consumption, importance of ANC and increasing the number of visits, adequate weight-gain monitoring, and early initiation of and exclusive breastfeeding. The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of pregnant and recently delivered women (i.e. with a child under 6 months of age) in 2019 and 2021.
Alive \& Thrive (A\&T) is an initiative that supports the scaling up of nutrition interventions to save lives, prevent illnesses, and contribute to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding practices. In Ethiopia, A\&T integrated a package of maternal nutrition interventions into existing antenatal care (ANC) services delivered through government health facilities (counselling on diet quality during pregnancy, distribution and promotion of iron-folic acid (IFA) supplementation, weight gain monitoring, counselling on early breastfeeding practices, and systems strengthening through training and supportive supervision) and community platforms (home visits, Pregnant Women Conferences/Mother Support groups, and community gatherings). The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys in 2019 and 2021.
The goal of this randomized controlled intervention trial is to evaluate an integrated, interdisciplinary, multi-level maternity care home model (MCHM) aimed at reducing severe maternal morbidity (SMM) among a group of Black indigenous and people of color (BIPOC) patients. The main question it aims to answer is whether a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable patients, thereby reducing SMM. Participants will be randomized to a MCHM (office-based prenatal care that is integrated with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced social services referrals) and followed during pregnancy through 1 year postpartum.
Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.
The goal of this pilot randomized controlled trial is to determine whether a 6-month behavioral health intervention with a Nurturing Care Family Navigator (NCFN) improves levels of food security among postpartum low-income Medicaid or uninsured women identified as having very low or low food security in the past 12 months. We hypothesize that a behavioral health intervention applying a multisectoral nurturing care navigation approach facilitating access to health, nutrition, early learning, responsive care, and security and safety resources is likely to decrease levels of maternal-child food insecurity. The main question it aims to answer is: * Does the behavioral health intervention with a Nurturing Care Family Navigator (NCFN) improves levels of food security? Outcome 1: Improve levels of food security * Does the behavioral health intervention with a Nurturing Care Family Navigator (NCFN) increase knowledge to navigate barriers across the four pillars of food insecurity? Outcome 2: Increase knowledge across the four pillars of food insecurity * Does the behavioral health intervention with a Nurturing Care Family Navigator (NCFN) increase self-efficacy to secure and sustain enrollment with community nurturing care services? Outcome 3: Increase self-efficacy to secure and sustain enrollment with community nurturing care services Researchers will compare levels of food security among those receiving a navigation behavioral health intervention (consisted of 1:1 tailored navigation session and an educational workbook) compared to those receiving an educational workbook with messages across the four pillars of food insecurity (standard of care). Participants will: * Engage in intense weekly navigation 1:1 tailored session for 3 months * Engage in follow up monthly navigation 1:1 tailored session for 3 months * Participate in evaluation calls with a research assistant at enrollment, 3, 6, 12 months
Maternal presence in the NICU during an infant's hospitalization is critical for the infant's medical recovery and overall neurodevelopmental trajectory. However, despite the importance of maternal presence in these settings, the current literature shows that families are often absent at bedside. To date, no behavioral interventions have been conducted to promote increased maternal visitation patterns in NICU settings. This project will aim to fill this gap in the literature by conducting a pilot study that uses a motivational interviewing intervention with the aim of increasing maternal visitation rates to a level IV NICU.
The purpose of this pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care for high-risk Black and Hispanic/Latina birthing people and reduce risk for severe maternal morbidity (SMM). Eligible Black and Hispanic/Latina birthing people (n = 674) will be recruited and randomized to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities.
The goal of this clinical trial is to test a behavioral intervention in pregnant women who identify as Black and live in Central Brooklyn. The main question it aims to answer is whether the WeCAB intervention leads to a net improvement in utilization of postpartum care compared to those receiving usual care. The WeCAB group will have a dedicated WeCAB community health worker who will be trained in digital care navigation. Researchers will compare the WeCAB group versus the group receiving usual care to see if the patients randomized to WeCAB will have higher rates of early post-partum care compared to patients in the control group.
The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: * Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? * Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? * Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.
The goal of this RCT is to evaluate the effectiveness of Joyuus on improving maternal functioning with postpartum moms. The main questions it aims to answer are: * The primary hypothesis is that participants of the Joyuus program will demonstrate improved functional status compared to the control arm participants at 3-month follow-up. * The secondary hypotheses are that participants using the Joyuus tool will demonstrate improvement in depression, anxiety, resilience, social support, and knowledge compared to the control arm at 6- and 12-weeks follow-up.
This study will determine the feasibility and acceptability of the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program, to test the clinical, behavioral, and strength building efficacy of the PARITY program and explore how it achieves its outcomes in pregnant Black women. PARITY is a program that provides community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths (referred to as protective assets) through positive messaging and by promoting wellness.
COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID vaccination rates for pregnant people overall. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of increasing maternal COVID-19 vaccination rates.