342 Clinical Trials for Various Conditions
Studies indicate that up to 75% of women will experience pain sometime during their pregnancy. Recent recommendations by the FDA recommended that non-steroidal anti-inflammatory (NSAIDS) medications be avoided during pregnancy. This recommendation limits the pain medications available for use during pregnancy. Antidotal evidence suggests that the FDA cleared Soovu pulsed heat device may produce pain relief during pregnancy. This study tests the Soovu device's ability to provide pain relief during pregnancy and up to one month post-partum and may eventually offer a safe nondrug option to treat pregnancy related pain. This is an observational pilot study The primary objective and hypothesis of this study is that the use of the Soovu pain management device will produce a significant reduction of pain when comparing pre versus post treatment pain.
A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. New guidelines from the American College of Obstetricians and Gynecologists recommend postpartum monitoring of blood pressures via blood pressure checks on day 3 postpartum and between days 7-10 postpartum. Our purpose is to compare the effectiveness of using a Bluetooth-enabled home blood pressure monitoring platform to the standard postpartum office-based blood pressure monitoring in performing the recommended postpartum follow-up for patients with hypertensive disorders of pregnancy.
A pilot randomized, controlled trial comparing Birthly, (an online platform for live group prenatal classes taught by childbirth educators, nurses, and lactation consultants) plus standard prenatal care versus standard prenatal care alone among women with high risk pregnancies.
This is a research study to understand the changes in the heart and the cardiovascular system that may occur in women who develop high blood pressure during pregnancy.
This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.
The findings from this project may result in pain reduction and improved mobility in pregnant women with pelvic girdle pain in their second and third trimester.
This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain.
Women in rural communities receive less access to prenatal care, and experience slightly higher rates of complications during pregnancy. A very prevalent pregnancy related complication is Pregnancy Related Pelvic Girdle Pain (PPGP), effecting up to 76% of all pregnant women. Historically, PPGP has been thought to originate from hormonal changes associated with pregnancy, but its cause is more likely due to loss of motor control and/or malpositioning of the pelvic bones. Despite growing interest and clinical awareness of the condition, treatment outcomes of PPGP are inconsistent and intervention studies are lacking. The goal of this proposal is to investigate a treatment modality with minimal risks and potential to be self-administered. The Mulligan Concept manual therapy technique aims to restore mechanical function of the lumbopelvic region and has yet to be measured in women with PPGP.
The purpose of this study is to examine the effectiveness of lumbopelvic stabilization exercises on women who have undergone Caesarian sections on: 1) disability using the Modified Oswestry Low Back Disability Index (OSW), 2) pain according to the Numeric Pain Rating Scale (NPRS), 3) percent change of muscle thickness of the deep abdominals using ultrasound imaging, and 4) perceived improvement using the Global Rating of Change (GROC).
The purpose of this study is to find out whether a technology-base healthy lifestyle program is an acceptable and effective way for African-American mothers to improve their eating and activity during pregnancy, compared to usual obstetric care. The goal of the program is to enhance the health of African-American mothers and their babies.
The purpose of this study is to see if pelvic girdle pain can be more effectively treated with the use of injectable anti-inflammatory medication plus physical therapy compared with physical therapy and a saline injection.
This is a randomized, double-masked, placebo-controlled, single-center study to evaluate stimulated C-peptide secretion after exogenous administration of mild immunosuppression and growth-promoting factors to women with preexisting T1DM who had a decline in insulin requirement or had detectable C-peptide during a previous pregnancy. Fifteen subjects will be enrolled and randomly assigned in a 2:1 ratio to either active treatment or placebo in a parallel group design. Participation for individual subjects will consist of an initial Screening Visit, a 2-week baseline period, a Baseline Visit, visits at week 2 and 4 of the treatment period, a visit at the end of the treatment period (week 6), and a follow-up visit 2 weeks after study treatment discontinuation. Subjects will receive either active treatment or matching placebo of estradiol 1 mg every 8 hours; medroxyprogesterone 2.5 mg every 24 hours; hydrocortisone 2.5 mg every morning, 1.25 mg every afternoon, and 1.25 mg at bedtime each night; and growth hormone 2 mg once a day).
This study compares three treatments for low back pain that started during pregnancy. The study hypothesizes that exercise, spinal manipulation, and a mind-body technique called neuroemotional technique (NET) equally affect pain intensity and disability associated with pregnancy-related low back pain. The study also hypothesizes that pain intensity and disability levels do not influence maternal heart rate variability (a measure of stress) and intrauterine attachment (a measure of relationship quality). Ten women will additionally provide blood and salivary oxytocin samples during pregnancy and periodically for three months after birth. These women and their babies will also be videotaped playing for 5 minutes at 2 weeks, 6 weeks, and 3 months postpartum.
The goal of this study is to better characterize peripartum cardiomyoapthy or pregnancy-related cardiomyopathy by enrolling as many PPCM survivors as possible using both direct and web-based methods of recritment. Patients will anser a questionnaire regarding the onset, progression, treatment and follow-up of their diagnosis as well as the psychosocial aspects of PPCM.
Medically tailored groceries (MTG), involving grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan, is a growing approach adopted by healthcare systems to address food insecurity in their patient populations, a leading contribution to health disparities such as poor birth outcomes within pregnant populations. However, transportation and other social needs can often hinder patient uptake of clinic-based approaches. Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to improve food literacy, behavioral and health outcomes.
Up to 5% of patients in the United States have a postpartum hemorrhage. "Postpartum hemorrhage" means excessive bleeding after delivery. The majority of these bleeds occur immediately with delivery. The current study focuses on hemorrhages that occur in the "medium-term" (1.5-24 hours after delivery). Investigators are examining whether ultrasound exams performed at the beginning of this period 1.5 to 2 hours after birth can identify markers that predict a medium-term bleed. Data collected for this study will include medical and obstetrical history, details about the course and outcomes of patients' labor and delivery, and particulars about postpartum bleeding. This information will be collected through the end of the patients' delivery admission and will allow correlation with the results of the ultrasound exam. If patients are re-admitted to the hospital after the delivery discharge, investigators may also collect relevant information about those admissions up to 6 weeks postpartum. All patients after term delivery (≥ 37 weeks' gestation) will be eligible to participate. Patients will be approached to provide consent for participation as early as feasible during a prenatal visit (≥ 36 weeks' gestation) or during the delivery admission. No subjects will be consented while in significant pain, \>6cm dilated without an epidural, or \>8cm dilatated with an epidural.
eDoula is an app that will give patients reading material and videos to watch based on their due date. It also provides helpful postpartum guidance. First, patients without access to the app will be recruited and surveyed on their labor and satisfaction outcomes. Then, recruitment will begin for the intervention arm of the study. Participants will be recruited to use the app and complete a survey during the postpartum period.
Previous studies have shown that pancreas size tends to be smaller in individuals with diabetes compared to those without diabetes. The investigators have recently found that pancreas size increases during pregnancy. The MAMA study aims to examine changes in the pancreas that occur during pregnancy, in both pregnant mothers and their babies, and find out how they are affected by maternal diabetes. The MAMA study is a prospective cohort study that will follow women and their babies through pregnancy and one year postpartum. Women aged 18-54, who are under 14 weeks pregnant are being recruited to participate in the MAMA study.
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.
This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.
The overall objective of this proposal is to conduct a longitudinal prospective study of healthy pregnant women and their offspring to determine which antenatal maternal exercise mode(s) will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to modified clinical practice recommendations that improve health in childhood and possibly beyond. This randomized controlled trial will recruit 268 healthy pregnant women randomized to an exercise intervention (aerobic exercise, resistance exercise, aerobic and resistance exercise) or to no exercise (usual care); their infants will be measured at 1, 6, and 12 months of age. This rigorous design will test our central hypothesis that aerobic and resistance exercise and resistance exercise training during pregnancy will, in healthy weight BMI (HW) women, improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. We will test this hypothesis with two specific aims: Aim 1. Determine the influence of different exercise modes during HW pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by HW pregnant women will improve offspring neuromotor and cardiometabolic measures at 1, 6, and 12 months postpartum (e.g. decreased % body fat, BMI z-score, heart rate, non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of HW pregnant women that do not exercise; AERE and RE will have the greatest impact on improving infant measures. Aim 2. Determine the most effective exercise mode in HW pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by HW pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, non-HDL, % body fat, HR, weight gain) across pregnancy (16 to 36 weeks gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to HW pregnant women that do not exercise; AERE and RE will have the greatest impact on improving maternal health measures, with the AERE group having the highest compliance. The proposed innovative study will be the first to provide a critical understanding of the influence of antenatal exercise modes upon the cardiometabolic health and growth trajectories of offspring who may be at increased risk of poor outcomes. This work will have a significant impact on reducing the cycle of OB and CVD, potentially providing the earliest and most efficacious intervention to attenuate or prevent OB and CVD in the next generation.
This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.
Myoinositol is an insulin-like compound that is present in both plant and animal cells. Humans synthesize it naturally, but it is also obtained in our diet. It works through an intracellular signaling pathway to increase insulin sensitivity. Myoinositol has been used as an over-the-counter (OTC) supplement in the management of polycystic ovarian syndrome due to this effect. Myoinositol has also been shown to improve glycemic profiles in pregnant euglycemic women and well as improve insulin sensitivity in pregnant patients with gestational diabetes mellitus (GDM). This is a double blind RCT offering myo-inositol or placebo to those who are eligible and enrolled.
The goal of this study is to conduct human factors validation testing with the Pulsenmore ES home Ultrasound device in the video-guided mode of operation (participants) and the clinician-guided mode of operation (participants and healthcare professionals (HCP)) to evaluate whether the device/user interface can be used by the intended users without any serious issues or errors under that intended use and actual use conditions. The intended users will be qualitatively assessed via observation and cognitive debrief and usability testing methodology. Participants will be remotely observed during the video-guided fetal scanning actual process and participants and HCPs will be remotely observed during the clinician-guided fetal scanning actual process.
This is a step-wedge design implementation protocol of an interprofessional education curriculum intervention that is delivered through virtual reality and designed to reduce disparities and improve patient experiences in receiving maternal healthcare.
With funding from the Episcopal Health Foundation, the researchers will conduct a secondary data analysis to evaluate the impact of Driscoll Health Plan's Nurture program for pregnant members using claims data.
The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are: 1. Is the Down Dog prenatal yoga app feasible for AA pregnant women? 2. How does mental and physical health change after using the Down Dog app for 12-weeks? 3. What cultural adaptations to the Down Dog app are needed? The study lasts for 12 weeks and participants are asked to: * do prenatal yoga with the app for at least 20 min/day, three days/week, from home * wear a Garmin Vivosmart 5 watch daily * complete four online surveys * complete an optional virtual interview This project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes.
This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.
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.
This study is to determine if there is any quantifiable correlation between serum beta hCG and dried blood spot (DBS) beta hCG levels. This data will be used to develop a less invasive collection method to determine quantitative hCG levels.