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Showing 1-20 of 83 trials
NCT05341960
This is a pilot project designed to test the feasibility of implementing a community health worker (CHW)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. The project will be conducted in partnership with the Greater Cleveland Food Bank and the Better Health Partnership Community Health Worker HUB
NCT07517406
Gestational diabetes mellitus (GDM) is associated with significant maternal and fetal complications. The standard diagnostic test for GDM is the 75-gram oral glucose tolerance test (OGTT). However, pregnant women who have undergone bariatric surgery may not tolerate OGTT due to dumping syndrome and gastrointestinal side effects. This creates diagnostic challenges in this specific population. The aim of this prospective observational study is to evaluate whether routinely measured glycemic markers, including fasting blood glucose, postprandial blood glucose, HbA1c, and urinary glucose levels, can predict the development of gestational diabetes mellitus and related pregnancy complications in women with prior bariatric surgery. Pregnant women aged 18-50 years with a history of bariatric surgery will be enrolled and followed throughout pregnancy. The predictive value of glycemic markers for GDM, macrosomia, and polyhydramnios will be analyzed using multivariable logistic regression models. This study aims to provide alternative diagnostic approaches for GDM screening in pregnant women who are unable to tolerate OGTT and to contribute to improving maternal and perinatal outcomes in this growing patient population.
NCT06941025
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.
NCT05329428
Vitamin D deficiency is common among certain risk groups in Sweden, and occurs approximately in every tenth pregnant woman.The aim of the randomized double-blind controlled trial Pregnancy vitamin D intervention (PREDIN) is to investigate the dose of vitamin D supplementation required in achieving vitamin D sufficiency (25OHD ≥50 nmol/l) in pregnant women at risk of vitamin D deficiency. In addition, the investigators aim to examine if the overall vitamin D status and vitamin D intake have increased since the expanded vitamin D fortification program was initiated in year 2020.
NCT06329596
The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation within the gingiva of the oral cavity, the health of the tissues in the mouth (clinical parameters of periodontal disease) and placentae, and the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi. In addition, we will evaluate the impact of xylitol-containing chewing gum use during pregnancy on the offsprings neurodevelopment at approximately 6- and 18-months corrected age.
NCT01520597
Listeriosis is a foodborne infection responsible for severe disease. Three main forms are described: septicaemia, central nervous system infections and maternal-fetal infections. Available data on the disease, are mostly retrospective and do not provide an accurate picture of the clinical / biological / genetic risk factors for the disease, nor identify any element to determine which patients are at higher risk of death, severe neurological impairment or fetal loss. The primary purpose of the study is to identify clinical, biological and genetic risk factors for systemic listeriosis and the determinants of listeriosis-associated mortality in the setting of a large prospective nation-wide study.
NCT03899961
Carbetocin has been in clinical use in EU for some years and the efficacy is documented in several RCTs. Circulatory adverse events leading to death has been reported after intravenous injection of oxytocin. Some studies indicate that oxytocin may lead to dose dependent ischemic ECG changes, prolongation of QT time and liberation of biomarkers of myocardial cell death. Previously the investigators have demonstrated comparable vasodilatory effects of oxytocin and carbetocin. There is no clinical study comparing the specific myocardial effects of oxytocin with carbetocin. It may have great impact on the choice of standard medication if the cardiotoxicity of carbetocin is lower compared with oxytocin. The study of potential cardiotoxicity has to be performed in healthy women. Knowing that millions of laboring women have had uneventful injections of oxytocin and carbetocin after delivery, there is probably no reason to fear long lasting negative effects of either drug. If there are differences in cardiotoxicity, this new information should be taken into consideration when planning delivery in pregnant women with heart disease.
NCT07292701
The aim of this study is to determine the effect kiensio taping in relieving pelvic girdle pain during pregnancy in terms of decrease pain and improving function and quality of life.
NCT06957769
The goal of this study is to learn how being exposed to high environmental temperatures during pregnancy affects the health of pregnant women and their babies. The study also aims to understand how the body responds to heat stress during pregnancy and how this might lead to pregnancy complications and birth problems like early birth or low birth weight. The main questions that the study aims to answer are: 1. What are the acute and chronic effects of environmental heat exposure on pregnancy and birth outcomes across different trimesters? 2. Through which biological pathways does heat stress impact maternal, fetal, and infant health across varying gestational ages? 3. How do socio-demographic factors, maternal characteristics, and nutritional status of women modify the relationship between environmental heat exposure and adverse pregnancy outcomes? The study will take place in rural parts of Sindh, Pakistan. These areas often experience extreme heat and have limited access to electricity or cooling systems like fans or air conditioners. This study will include pregnant women who are in their first trimester (under 14 weeks of pregnancy). Before starting any study activities, researchers will explain the study to each woman in a language she understands and ask for her written permission to take part (informed consent). At the beginning of the study, participants will visit a study clinic. During this visit, researchers will check their height and weight, perform an ultrasound, and collect a small amount of blood for testing. Participants will also be asked to wear a small device that measures the air temperature and humidity in their surroundings. The researchers will follow each participant during her pregnancy, with visits during the second and third trimesters at the study clinic. At each visit, researchers will check how much heat the participant has been exposed to using the data from the device and from her own answers to a simple questionnaire. The questionnaire will have questions about their heat exposure at work, home, type of clothing, and how they deal with hot weather. Serial ultrasound, blood and urine tests will be conducted so researchers can study signs of stress, hydration, and other changes in the body. A smaller group of participants will also wear a device to measure their body skin temperature, heart rate, physical activity and sleep during pregnancy. When the baby is born, researchers will collect information about the birth, including the baby's weight and length, the time of delivery, and whether there were any complications during birth. After delivery, both the mother and baby will be followed for up to 12 months. During this time, the research team will check the health of both the mother and baby and see how heat exposure during pregnancy may affect the baby's growth over time. At delivery, placental weight and volume will be collected for a smaller group of women. Breastmilk sampling will also be done for this group of women to understand the effect of high temperatures on breastmilk quality. This study does not involve any treatment or medicine. Instead, researchers will observe the participants to learn how real-life heat exposure affects them during pregnancy. The findings from this study may help public health officials and governments find better ways to protect pregnant women and babies from the harmful effects of climate change and extreme heat, especially in places with limited resources.
NCT06430853
This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation.
NCT06357962
Cervical ripening is a medical treatment that can cause physical or emotional discomfort in pregnant women and is not without risks. This is a pilot study to assess feasibility and calculate the number of participants necessary for a complete clinical trial. The aim is to evaluate whether acupuncture can reduce the need for treatment (cervical ripening) in pregnant women at low or intermediate risk. Participants will be divided into two groups: one group will receive acupuncture, and the other will receive a simulated treatment of acupuncture.
NCT05790252
The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are: 1. Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder? 2. Is there a buprenorphine induction method that results in a higher treatment success rate? Under normal circumstances, patients who are planning to start sublingual (under the tongue) buprenorphine for opioid use disorder must first go into withdrawal to start the medication safely. Study participants will be given a buprenorphine patch during the required withdrawal period before starting sublingual treatment, and be surveyed daily by phone to assess their withdrawal symptoms. They will also be followed at prenatal appointments to evaluate treatment success based on urine drug screen results. Researchers will compare patients receiving no buprenorphine patch according to the current standard care protocol.
NCT05264779
The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0/7 - 25 6/7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.
NCT03228875
Early life exposures may lead to adverse effects on health in later life. The Boston birth Cohort study is designed to study a broad array of early life factors and their effects on maternal and child health outcomes.
NCT06237920
This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment
NCT05739123
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.
NCT06711627
The overarching research question is: "Does the provision of healthy food during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with standard of care (SoC)?" To answer this question, the investigators will conduct a randomized controlled trial with 400 pregnant women. Participants will be randomized 1:1 to either the Food Provision arm or the SoC arm, with approximately 200 participants per arm. Participants randomized to the SoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, as well as $500 after delivery to be used specifically for baby items.Those randomized to the Food Provision arm will be provided the same nutritional and gestational weight gain counseling, as well as a total of $1000 during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome will be collected from birth records and from surveys conducted at baseline (pre-intervention), midpoint (between 24-36 weeks gestation), and post-intervention (\~8 weeks post-partum).
NCT05786235
The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS. To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM). For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.
NCT06926166
The long-term goal of the Human Genes and Microbiota in Early Life (HuGME) is to explore the short- and long-term effects of maternal microbiota during pregnancy and the microbiota colonization of their offspring early in life and their interaction with the host on maternal-offspring health consequences in later life in the born in Guangzhou cohort study in China. Identification of the effect of microbiota in early life, as well as environmental factors and microbe-host interaction, will lead to a better understanding of disease pathogenesis and provide a foundation for targeted mechanistic investigation into the consequences of microbial-host crosstalk for long-term health. It also can result in new strategies to predict and prevent diseases in later life.
NCT03981328
Real-time continuous glucose monitoring (CGM) systems provide users with information about current glucose levels and alert the patient before the upper or lower glucose threshold is reached or when glucose levels change rapidly. Hence, glycaemic excursions can be early identified and accordingly adapted by behavioural change or pharmacologic intervention. Randomized controlled studies adequately powered to evaluate the impact of long-term application of real-time CGM systems on the risk reduction of adverse obstetric outcomes are missing.