2,247 Clinical Trials for Various Conditions
T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.
Diabetes Mellitus, Type 1, Pregnancy in Diabetics, Pregnancy, High-Risk, Insulin Dependent Diabetes
The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are: (1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.
Gestational Diabetes Mellitus in Pregnancy
The investigators seek to adapt a collaborative care model (CCM) for community-based, low-resource obstetric settings and to test the effects of this adapted CCM on health outcomes among Pregnant, postpartum, and parenting person (PPPP) with Opioid use disorder (OUD) and their families. To achieve this goal, investigators will conduct a nonrandomized, Type 1 hybrid implementation-effectiveness study across 3 community-based, low-resource obstetric sites in Northwest PA, a region with rates of maternal opioid-related diagnoses 4 times higher than national averages.
Pregnancy, Postpartum Period, Opioid Use Disorder
The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and/or during pregnancy and lactation. The main objectives are to: * Assess pregnancy outcomes, including maternal and infant health. * Evaluate the occurrence of congenital malformations and other neonatal outcomes. This is a global, decentralized, single-arm, prospective and retrospective registry planned to enroll participants over a 10-year period. Eligible patients may be enrolled by their physician or may self-enroll, where permitted by local regulations. Data will be collected through a secure web-based platform, allowing patients and physicians to enter information via electronic case report forms (eCRFs). Pregnancy and clinical outcomes will be documented throughout pregnancy and up to 12 months post-birth. Data from self-enrolled patients will be confirmed by their primary care or attending physician. This registry is observational and does not impact clinical care or treatment decisions.
Fabry Disease, Pregnancy, Pregnancy Complications
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.
High-risk Pregnancy
Data collected through the registry may be used to address a range of research questions and objectives, including but not limited to the following: Research question: Is there an increased risk of adverse maternal, fetal, or infant outcomes among individuals who are exposed to Inflammatory Bowel Disease (IBD) treatments during pregnancy? The primary objective of the registry is to estimate the prevalence of major congenital malformations among pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy. The secondary objectives of the registry are: To estimate the prevalence of other maternal, fetal, and infant outcomes among pregnant individuals with IBD who are exposed to IBD pharmacotherapies during pregnancy. To contextualize the prevalence of outcomes among pregnant individuals who are exposed to IBD pharmacotherapies during pregnancy and estimate the prevalence of all outcomes of interest among pregnant individuals with IBD who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy. If sample size permits, to estimate the risk ratio for each outcome, comparing the outcomes of pregnant individuals with IBD who are exposed to IBD pharmacotherapy with those who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy. Data collection may be used to determine pharmacotherapy-specific use with or without unexposed cohorts on an as-needed basis, as sample size allows.
Inflammatory Bowel Disease (IBD)
The goal of this randomized controlled clinical trial is to determine if healthy lifestyle education can help improve cardiovascular health and reduce pregnancy complications in women during the preconception period or early pregnancy. The main aims include: 1. Determine the feasibility and acceptability of the LEAN into pregnancy study. 2. Determine the impact of healthy lifestyle education on Life's Essential 8 cardiovascular health score. 3. Determine the impact of health lifestyle education on adverse pregnancy outcomes, specifically gestational diabetes and preeclampsia. A total of 200 participants will be randomly assigned to receive healthy lifestyle education in addition to routine care, or routine care alone. Participants will be asked to participate in the following activities: * Blood draws to test hemoglobin A1c and lipids * Surveys about diet, physical activity, sleep, and tobacco use * Gaples Nutritional Education Modules (if applicable)
Pregnancy, Preconception Education, Preconception Care, Preconception Risk, Adverse Pregnancy Outcomes
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.
RSV Infection
Aspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. The investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. This is a Phase I/II randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. Outcomes evaluated will include the difference in aspirin response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.
Preterm Birth, Preeclampsia
Antenatal nonstress tests (NSTs) are performed to assess fetal health and are used as a cost-effective test that can be widely administered. However, an NST is operator-dependent due to the nature of Doppler ultrasound and is primarily performed in a clinic and hospital setting. The ability to conduct a clinically valuable test at home would address access to care issues faced by numerous women in the United States and reduce the workload on healthcare clinicians facing a shortage of human resources. This pilot study aims to assess the feasibility and acceptability of home NST monitoring in order to determine whether femomTM could be utilized as an adjunct to routine prenatal care. Patients with high risk pregnancies who are recommended to undergo at least once weekly at 32 weeks testing by the obstetrician will be recruited for participation in this study. Participants will be asked to perform three 30 minute monitoring sessions weekly starting at 32 weeks for 6 weeks.
High Risk Pregnancy, Remote Patient Monitoring, Diabetes, Hypertension
This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia. Further, we will add an exploratory outcome to evaluate the neonatal body composition and anthropometric data to better understand neonatal impacts of maternal metabolic dysfunction.
Preeclampsia, Preeclampsia (PE), Preeclampsia (PE) Risk, Obesity and Obesity-related Medical Conditions, Pregnancy, Pregnancy Complications, Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy, Gestational Complications
This online registry aims to understand the potential benefits and safety of external trigeminal nerve stimulation for the treatment of migraine in pregnant women. Women do not need to use external trigeminal nerve stimulation or any other form of migraine treatment to participate in the registry. The main question it aims to answer is: Is external trigeminal nerve stimulation a safe and effective option for migraine treatment during and after pregnancy? There are no required changes in migraine treatment to participate in this registry. Participants may or may not use external trigeminal nerve stimulation or any other treatment they currently use and may still participate in the registry. There are no clinic or research visits, as the registry is entirely online. Participants will be asked to complete up to six 15- 20-minute surveys over a time period of up to 12 months.
Pregnancy, Migraine, Headache, Postpartum, Depression, Anxiety
The primary purpose of the study is to compare the occurrence of major congenital malformations (MCMs) among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with insomnia who are not exposed to any prescription insomnia drugs at any time during the pregnancy and to compare the occurrence of MCMs among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with insomnia who are exposed to a prescription insomnia drug other than Dayvigo during the 1st trimester of pregnancy.
Sleep Initiation and Maintenance Disorders, Pregnancy
Stress-induced pregnancy complications are significant contributors to preterm labor as well as maternal and perinatal morbidity and mortality. The goals of this study are two folds: first it aims to capture the pregnant woman's journey to seek and receive prenatal care. Second, this study aims to develop models that 1) assess the adverse health and biological effects of social factors on pregnant women who experience repeated or chronic stress, 2) address how stress can be mitigated in pregnant women from different backgrounds who experience high stress.
Pregnancy
The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients who are already receiving treatment for opioid use disorder. The main question it aims to answer is: Does PE+ decrease PTSD symptoms? All participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning. Participants will: * Receive individual PE+ therapy for 1 hour weekly for 12 weeks. * Receive financial incentives for attending each PE+ session. * Attend assessment visits every 4 weeks for the 12 weeks of the trial. * Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.
Posttraumatic Stress Disorder, Opioid Use Disorder, Pregnancy
The investigators aim to conduct a feasibility randomized controlled trial (RCT) of an eating disorder prevention program (The Body Project, adapted for pregnancy) versus a health education control among pregnant individuals with histories of an ED. The investigators will test the feasibility, implementation outcomes, and its preliminary effectiveness in reducing the risk of elevated disordered eating and body dissatisfaction during pregnancy and postpartum.
Eating Disorders, Body Dissatisfaction
The goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with Opioid Use Disorders through digital technology (e.g. smartphones). The main question it aims to answer is: • What is the feasibility of providing customized digital parenting and recovery supports to pregnant people with Opioid Use Disorders residing in natural communities? o Feasibility data includes data on study interest, eligibility, time to enroll, participant training on digital app usage, attrition; Secondary outcome exploratory data will include MOUD treatment retention, missed follow up prenatal and early postpartum appointments, drug usage, and parenting outcomes (i.e., scores on the Parental sense of competency scale, Self-rated abilities for health practices scale, and Self-efficacy in infant care scale) through self-report; The intervention group only will also be observed regarding app usage, frequency of use, resources accessed, thoughts about the app, and what was found to be helpful. Researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes. Participants will complete the following tasks: * Schedule an online meeting with the research team to receive more information about the study. Once consented to participate, the participant will be randomly assigned to one of the groups. * Complete survey questions within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about drug usage, missed follow-up medical appointments, and parenting outcomes. The total time to complete the survey after consenting to be in the study will take approximately 40 minutes. The total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes. * Complete a one-hour virtual interview at three months post-delivery (by phone or computer) about the study experience.
Digital Intervention, Bibliotherapy
The goal of this observational study is to use digital health tracking to improve how high blood pressure and other health issues are detected in pregnant refugee women. The main questions this study aims to answer are are: * Can a digital monitoring system that checks for high blood pressure in these women be tested and refined, using clinical training and validation? * Can this digital monitoring system accurately track any related pregnancy health issues and be used to refer participants to care providers? * Can this system be used to accurately identify risks associated with the contraction of pregnancy-related conditions, such as preeclampsia and high blood pressure? Participants will: * Complete baseline and follow-up in-person appointments; * Complete surveys at these appointment that track their health, stress levels, and comorbidities/risks associated with pregnancy; * Be given a smartwatch fitness tracker and electronic blood pressure cuffs for at-home measurements.
Gestational Hypertension
The purpose of this study is to offer routine lab-based and rapid point of care (POC) syphilis diagnostic testing in the emergency department (ED) and obstetrical (OB) triage , thereby increasing screening and treatment initiation for pregnant patients without prenatal care or with no documented syphilis results during the index pregnancy in other to increase rates of full treatment to determine if the implementation of a robust linkage to care program for pregnant patients with positive rapid POC results will more likely result in complete treatment for all stages of syphilis and adherence to recommended maternal and newborn longitudinal follow up and to assess factors that contribute to treatment completion after implementation of the intervention will also be analyzed to tailor efforts targeting social and healthcare navigation factors that affect health equity; including poverty, insurance, health literacy and others.
Syphilis
This research activity looks at the safety of an investigational intervention, a mobile health (mHealth) app called JUN, that uses artificial intelligence (AI) to track symptoms and give time-sensitive feedback to pregnant women. JUN is an intervention being developed to provide education and assist with decision making during pregnancy. The researchers hope to learn differences in how effectively the participant use of the app is amongst women with and without criminal justice oversight such as adult probation or parole.
Pregnancy Related, Pregnancy
The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are: 1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose? 2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose? 3. What other factors increase the risk of maternal and infant complications? Participants will: 1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery 2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis 3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits 4. Have umbilical cord blood collected at delivery for analysis
Type 2 Diabetes Mellitus (T2DM), Pregnancy
Osteopathic Manipulative Therapy (OMT) is a hands-on approach to treating conditions that affect all areas of the body. Physicians trained in OMT (Doctors of Osteopathic Medicine or DO) use OMT to correct structural imbalances in the body, relieve pain, and improve circulation. Research shows that manual therapy is equally or more effective in treating pain and improving function versus oral analgesics (Bodine). OMT can decrease cost and improve function in patients with a minimal adverse effect profile. OMT applications include relieving asthma, irritable bowel syndrome, fibromyalgia, migraines, carpal tunnel syndrome, and sports-related injuries. In addition to the indications listed above, there is a growing body of research surrounding the use of OMT in pregnancy and its use in treatment and prevention of complications peripartum. Research Question: Does OMT during the third trimester of pregnancy improve delivery outcomes including: decreased labor times, less utilization of analgesics, fewer incidences of meconium fluid and perineal lacerations, and reduced risk of conversion to c-section or operative vaginal delivery? Though all research has shown that OMT is safe in pregnancy, there has been conflicting data on its benefits during the peripartum period. Additional research is needed to show its utility in decreasing labor times and need for analgesics during labor and reducing incidence of adverse outcomes including perineal lacerations and conversion to c-section and operative vaginal delivery. The current study will add to the growing body of knowledge about OMT during pregnancy and its potential benefits outside of musculoskeletal pain relief.
Pregnancy, Osteopathic Manipulative Treatment (OMT)
The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and/or lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.
Gestational Diabetes Mellitus in Pregnancy, Glucose Intolerance During Pregnancy, Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation
This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.
Pregnancy Early, PTSD
The research question is: What is the risk of adverse pregnancy outcomes, including preterm birth, hypertensive disorders, and other maternal and neonatal/infant outcomes, following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation in the CorEvitas Respiratory Syncytial Virus Vaccine Pregnancy Registry (RSV-PR)? The primary study objective is to estimate the risk of (1) preterm birth and (2) hypertensive disorders following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation. The secondary study objective is to estimate the risk of other safety outcomes of interest following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including: * Pregnancy-related outcomes: stillbirth, premature labor, premature rupture of membranes, preterm premature rupture of membranes, cesarean delivery, prolonged maternal duration of hospital stay * Maternal outcomes: thrombocytopenia, Guillain-Barré syndrome, other immune-mediated demyelinating conditions, polyneuropathies, atrial fibrillation, maternal death * Neonatal/infant outcomes: small for gestational age, large for gestational age, low birth weight, admission to a neonatal intensive care unit (NICU), NICU duration of stay, mechanical ventilation in neonatal period, neonatal death, postnatal growth at 1 year of age The exploratory study objective is to describe the most frequently reported maternal adverse events following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation.
Respiratory Syncytial Virus (RSV)
Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial center and provide a sample of urine from the same void for further testing. Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.
Pregnancy
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Insomnia
This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief therapy protocol and a mobile application. Participation involves four 60-minute therapy appointments during pregnancy, and four 30-minute therapy appointments at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll (early second trimester-mid third trimester). Compensation is provided.
Opioid Use Disorder, Pregnancy Related
This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.
Iron-deficiency Anemia (IDA), Pregnancy
The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.
Hypertensive Disorders of Pregnancy, Preeclampsia, Gestational Hypertension