56 Clinical Trials for Various Conditions
The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk pregnancies and in the infants born to the vaccinated mothers. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study.
Most newborns experiencing Neonatal Abstinence Syndrome (NAS) require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies while they are pregnant, yet, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, in part because no interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. In this project, the investigators propose to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled analog trial.
The goals of this study are to determine the feasibility and efficacy of a brief, single-session cognitive-behavioral intervention for reducing preoperative and postoperative anxiety and for determining satisfaction with the delivery process in pregnant women scheduled for Cesarean delivery due to complications with their pregnancy. This will be done through a combination of psychoeducation and exposure therapy, where the participants will be walked through the steps of a Cesarean delivery in an operating room that mimics where the patient would actually be delivering. Follow-up will occur during the immediate and extended postpartum periods to determine satisfaction and levels of anxiety.
The goal of this randomized supplementation feasibility trial is to learn about the feasibility and preliminary efficacy of the probiotic, lactobacillus plantarum 299v (Lp299v), in pregnant individuals at-risk for iron deficiency anemia. The main questions it aims to answer are: * Is daily oral Lp299v a feasible and tolerable intervention for pregnant individuals to uptake? * Does daily oral Lp299v in pregnancy impact maternal and neonatal cord hematological and iron status parameters? Participants will be randomly assigned to one of two treatment groups: daily intake or probiotic Lp299v + prenatal vitamin with iron or placebo + prenatal vitamin with iron from 15-20 weeks of gestation through delivery. Researchers will compare the two treatment groups to see if there is a difference in the feasibility of the intervention and the preliminary efficacy on maternal and neonatal cord hematological and iron status parameters.
Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.
to Assess the Pharmacokinetic Properties of VeraCept™ Intrauterine Contraceptive vs ParaGard® in Healthy, Post- Menarcheal Women
To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept
iSpecimen aims to create a clinical partner network of hospitals, laboratories, academic institutions, and other healthcare organizations ("institutions") capable of providing researchers and educators ("researchers") with annotated biospecimens for use in biomarker discovery and validation; diagnostic test and instrumentation development and validation; therapeutics development; other medical research including the impact that various specimen collection and handling methods and conditions have on research results; and in education such as researcher or physician training (collectively "research").
To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept
iSpecimen aims to create a clinical partner network of hospitals, laboratories, academic institutions, and other healthcare organizations ("institutions") capable of providing researchers and educators ("researchers") with annotated biospecimens for use in biomarker discovery and validation; diagnostic test and instrumentation development and validation; therapeutics development; other medical research including the impact that various specimen collection and handling methods and conditions have on research results; and in education such as researcher or physician training (collectively "research").
This study recruits pregnant women and new mothers who are at risk of substance use concerns during pregnancy or delivery. These women are followed for 6 months and randomized into two groups; they may receive services as usual, or enhanced services. Enhanced services include evidence based interventions and case management to support referrals to substance abuse treatment, and to teach strategies specifically targeted to parenting newborns.
The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.
We propose to develop and pilot test an intervention that addresses both sex- and drug-related HIV risk behavior among pregnant women in drug treatment. In the first phase of the study, we will conduct focus groups with pregnant women in drug treatment, as well as a focus group with their treatment providers, in order to determine key areas of emphasis for an intervention in this population. We will then develop an HIV risk behavior intervention for pregnant women in drug treatment, pilot the intervention with 20 women, and elicit their feedback regarding the intervention. Following refinement of the intervention, we will conduct a small randomized trial (n=60) to examine the impact of the intervention compared to standard care (SC). We expect that, relative to SC, participants randomized to the intervention condition will have lower levels of sex- and drug-related HIV risk behavior.
Researchers are evaluating the safety of triptan treatment of migraine in individuals with elevated cardiovascular risk and in pregnant women.
The purpose of this trial is to determine whether a stretching intervention is superior to a usual care control condition (moderate/vigorous activity 30 minutes daily, 5 days per week) for pregnant women from 27 to 37 gestational weeks.
The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). The effectiveness of the investigational drug M281 will be measured by looking at the percentage of participants with live birth at or after gestational age (GA) 32 weeks and without a need for an intrauterine transfusion (IUT) throughout their entire pregnancy.
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
Obesity is a major risk factor for hypertensive disorders of pregnancy (HDP). The underlying mechanisms are largely unclear, but maternal vascular endothelial dysfunction is likely involved. Endothelial dysfunction in HDP could be attributed to 1) alterations in the L-arginine/nitric oxide (NO) pathway, and 2) an increase in endothelin-1 (ET-1). Additionally, augmented sympathetic vasoconstriction may also contribute to HDP. Chronic (repeated) whole-body heat exposure has been shown to increase NO bioavailability, decrease ET-1, and cause functional and structural adaptations in the vasculature. All these can improve vascular function, attenuate sympathetic (re)activity, lower blood pressure (BP), and reduce cardiovascular risk in non-pregnant individuals. Whether this is also true after regional (leg) heating in high-risk pregnant women is unknown. The investigators' central hypothesis is that chronic leg heating will be effective in improving vascular endothelial function and attenuating sympathetic vasoconstriction, leading to a reduction of the risk for HDP in pregnant women with obesity. The overarching goal of this proposal is to determine the vascular and neural effects of chronic leg heating in obese pregnancy. The study team plans to enroll pregnant women with obesity between 12-14 weeks of gestation and randomly assign them to either an intervention group or a control group (1:1 ratio). Participants in the intervention group will perform 16 weeks of home-based leg heating using a portable sauna blanket up to the hip (temperature of the blanket will be set at 65°C, 4 times/week, 45 min/session), whereas women in the control group will set the temperature of the blanket at 35°C at the same frequency and duration. Participants will be evaluated at baseline and then at 28-30 weeks of gestation. Aim 1 will determine the effects of chronic leg heating on maternal vascular function and surrogate markers of HDP. Aim 2 will determine the effects of chronic leg heating on sympathetic vasoconstriction and BP. Findings from this project will provide insight on the extent and potential mechanisms of how chronic leg heating works for improving vascular endothelial function and sympathetic vasoconstriction in pregnant women with obesity. Results obtained will set a foundation for future large multicenter clinical trials to determine the efficacy and generalizability of home-based leg heat therapy as a safe, ease-of-use, cost-effective, and non-drug approach for reducing the risk of HDP.
Postpartum depression (PPD) is associated with significant health consequences for mothers and children, and the current COVID-19 pandemic has had a major impact on the mental health of particularly vulnerable populations including pregnant Black and Latina women. There is an urgent need for evidence-based, accessible, and scalable mental health care options for these high-risk, vulnerable women. This study aims to: (a) compare the effectiveness of two digitally-delivered self-paced stress reduction programs in pregnant Black and Latina women at increased risk of PPD; and (b) examine barriers and facilitators to implementation within a large healthcare system.
This is a prospective, single-institution observational study to be conducted at 4 clinics within the Southern California Permanente Medical Group. Pregnant women who present for prenatal genetic counseling at the designated clinics and who meet study eligibility criteria will be offered the option of the verifi® prenatal test by a trained, licensed and certified genetic counselor (GC) . Women who elect the verifi® prenatal test will have a blood sample drawn by peripheral venipuncture that will be sent to the Verinata Health CAP-accredited clinical laboratory (Redwood City, CA). Results will be reported to the ordering health care provider by the laboratory within 8-10 business days and will be shared with the subject by their provider. Subject care and decision-making following NIPT result will be clinically managed by the provider with his/her subject and is not dictated by the study protocol. All eligible women who provide informed consent, whether they elect or decline NIPT will be asked to complete a short questionnaire on their views of prenatal testing. The uptake of invasive prenatal procedures (CVS and/or amniocentesis) by the total prospective cohort will be collected through review of electronic medical records (EMR). A historical cohort with matched demographic and pre-test indications to the prospective cohort will be identified from the EMR for comparison in the primary analysis.
The project objective is to validate a new indirect estimate of insulin status in both pregnant African-American women and Caucasian women in southern Louisiana who are at risk for gestational diabetes mellitus. There are racial differences in carbohydrate metabolism that are potentially linked to complications during pregnancy and to increased risks of obesity and diabetes in later life. The investigators will explore the use of indexes of insulin status to identify the metabolic risk profile of pregnant women which may vary by race. Understanding whether there are differences which vary by race may influence clinical screening and treatment of pregnant women.
This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied. Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems. Nifurtimox has been used for more than 50 years to treat Chagas disease in children and adults. It is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans. In this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information: * Birth defects (abnormal and problematic structures or functions, a child is born with) * Pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion) * Certain health problems of the child up to 12 months of age * Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population. The study will run for approximately 10 years.
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth. The investigators will deliver a psychoeducational intervention that is manualized over 6 group sessions. The investigators will also have a usual care group that receives standard prenatal care. The investigators plan to enroll 238 pregnant women and start the study with them at 14-20 weeks gestation. The investigators will also test the biological response of the intervention by measuring Corticotropin Releasing Hormone, progesterone, estriol, and test for cotinine. The investigators will also determine any effect on infant outcomes at delivery.
The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.
This trial will evaluate a multi-component, clinic-based intervention aimed at increasing dual protection strategy selection and adherence among young African American females at an urban family planning clinic. Dual protection is the use of contraceptive strategies to prevent both unintended pregnancy (UIP) and sexually transmitted infections (STIs). This is an unblinded randomized controlled trial; participants will either get the interactive multimedia platform focused on DP strategies with intervention arm counseling or the standard of care arm counseling. The study will recruit 710 African American females aged 14-19 who are attending the Grady Health System (GHS) Teen Services Clinic (TSC) in Atlanta, Georgia, for reproductive health care. The trial will recruit and enroll 710 young women presenting to the clinic for clinical care who have the following characteristics: * self-identify as African American, * 14-19 years of age, * have had vaginal sex with a male partner in the past 6 months, * HIV-negative by self-report, * not pregnant,verified by urine pregnancy test, * no desire to be pregnant in next 12 months, * plan to stay in the Atlanta area for the next year, * are willing to provide contact information, and * were not previously enrolled in the pilot study of this intervention. Those enrolled will be in the study for 12 months. Young women who are eligible and give written consent or assent for study participation will be enrolled. Half will be randomized to the control arm, half to the intervention arm. 1. Control arm (standard of care) includes individual clinical care and standard of care counseling consistent with protocols at the TSC, with study visits for data collection at enrollment, 6 months, and 12 months, during which any medical care or counseling that they would normally get will also be provided. Control arm participants will also get telephone calls from clinic staff to update their contact information and remind them of upcoming visits at 3 weeks and 5 months after the enrollment visit, and at 3 weeks and 5 months after the 6 month visit. 2. Intervention arm, consisting of the following intervention components: 1. Enrollment visit * A culturally-appropriate interactive multimedia platform focused on DP strategies and designed to prepare the individual for selection of a DP strategy. * Individual intervention arm counseling to select the DP strategy that is best suited for the participant (by a clinic health care provider). * Individual intervention arm counseling to build skills for correct and consistent use of the selected DP strategy (by a nurse educator (NE)). 2. Booster counseling via phone at about 3 weeks and 5 months after the enrollment visit, and at about 3 weeks and 5 months after the 6 month visit (by an NE). 3. 6 month visit * An abbreviated version of the interactive multimedia platform focused on dual protection strategies and strategy adherence. * Individual intervention arm counseling to reinforce skills for correct and consistent use of the DP strategy (by an NE). At the final study visit at 12 months there is no difference between the counseling provided to the two groups; participants in both arms will receive the clinic standard of care. Participants in both arms of the study will follow the same data collection procedures throughout the study: * At all three study visits, participants in both arms will receive urine pregnancy and STI tests and complete an audio computer assisted self-interview (ACASI) questionnaire. * At 3 and 9 months after enrollment, participants in both arms will receive a data collection call with administration of a telephone questionnaire. Throughout the study, all participants will be encouraged to come in for evaluation if they have any concerns. Any data from pregnancy or STI testing at these interim clinic visits will be later collected via chart review. If participants seek reproductive health care at other facilities during the study period, records will be requested with participant permission, and data from pregnancy or STI testing at these outside clinic visits will be collected via review of records received. We will examine the efficacy of the intervention arm relative to control arm across the following primary behavioral and biologic outcomes over the 12 months of follow-up: 1. Self-reported dual protection strategy selection 2. Self-reported dual protection strategy adherence 3. Incidence of pregnancy or infection with chlamydia, gonorrhea or trichomonas (as confirmed by laboratory testing) A small pilot study was be conducted prior to the initiation of enrollment in the main study.
This study is an examination of "high risk" young women, 15-24 years of age, who initiate first time use of vaginal ring, oral contraceptives, contraceptive path, or Depo-provera.
The goal of this clinical trial is to test the Nurse Family Partnership (NFP) in mothers with previous live births (multiparous or multip individuals). The main aims are: Specific Aim 1-Determine the effectiveness of NFP among multiparous women for reducing maternal morbidity and improving pregnancy outcomes. Specific Aim 2-Determine the effectiveness of NFP among index children (child from pregnancy when mother was enrolled) of multiparous women for improving child outcomes. Specific Aim 3 (Exploratory)-In preparation for a future study of the effects of preventive home-visiting programs on mother-index child-sibling triads, describe siblings (characteristics, role, influence) in the context of nurse home-visiting and evaluate the effectiveness of NFP on outcomes for prior-born siblings younger than 6 years old living in the home, including cognitive development, socioemotional development, and identification and referral to needed services. A supplemental study to this study, led by investigators at Yale and Columbia, includes the following Aims: Aim 1: Test whether the NFP causes variation in DNAm at Glucocorticoid-sensitive sites in infants over the first year of life. Aim 2: Determine whether NFP causes differences in epigenetic age in infants over the first year of life. Aim 3: Evaluate DNAm signatures as predictors of infant development at 12 months of age.
The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.
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
A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in these women.