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Found 3 Actively Recruiting clinical trials
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Researchers are studying how exposure to high environmental temperatures during pregnancy affects the health of pregnant women and their babies. The study focuses on understanding how heat stress impacts pregnancy complications and birth problems such as early birth and low birth weight. It also aims to explore biological pathways through which heat stress influences maternal, fetal, and infant health across different stages of pregnancy, especially in rural Sindh, Pakistan, where extreme heat and limited access to cooling are common. Participants in the study are pregnant women in their first trimester. They will wear small devices to measure air temperature and humidity around them and answer questionnaires about their heat exposure and coping strategies. Researchers will conduct ultrasounds, blood and urine tests during each trimester to study biological changes related to heat stress. A smaller group will wear additional devices to monitor skin temperature, heart rate, physical activity, and sleep. Birth information will be collected, including newborn weight and length, and a subgroup will provide placental tissue and breastmilk samples. Throughout the pregnancy and for 12 months after birth, researchers will follow mothers and babies to assess health outcomes and growth. They will measure pregnancy complications and newborn health indicators such as low birth weight and small vulnerable newborns. The study involves regular clinic visits, biological sample collections, environmental monitoring, and detailed assessments to understand how heat exposure affects maternal and infant health. Safety monitoring and referrals for health issues are also part of the study process.
Actively Recruiting
Researchers are investigating Environmental Enteric Dysfunction (EED), a gut condition linked to malnutrition, poor brain development, stunting, vaccine failure, and infections in children. This Phase II trial focuses on pregnant women colonized with certain harmful gut bacteria to see if an oral antibiotic followed by a probiotic can reduce these bacteria and improve gut health. The study takes place across multiple countries, including Pakistan, where pregnant women in their first or early second trimester are enrolled. Participants will be randomly assigned to one of three groups: oral vancomycin antibiotic capsules taken three times daily for five days, followed by either the probiotic VE818 or a placebo for two weeks, or an observation-only group. VE818 is a specially designed mix of 11 bacterial strains intended to displace harmful bacteria and reduce gut inflammation. The trial is double-blind, with careful control and monitoring throughout the treatment period. During the study, researchers will collect various biological samples including blood, urine, vaginal swabs, stool, and gastrointestinal samples using a non-invasive capsule device. They will track adherence daily and monitor for any adverse effects. Assessments such as ultrasounds, body measurements, and stool tests will be done at multiple points during pregnancy and one month after birth. The main outcome measured is the change in levels of 11 specific harmful bacteria in the gut before and two weeks after completing the treatment course.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating simple, low-cost ways to protect health and quality of life during extreme heat in rural, low-income villages of Matiari, Pakistan. The study focuses on whether home cooling improvements, practical advice, and minor home changes can reduce heat-related health problems like dizziness and heatstroke, as well as improve sleep, comfort, and daily functioning. Communities receiving heat-related support will be compared to similar communities without such support to understand the impact on health and well-being. The study involves two main interventions. First, community education through mobilization groups that raise awareness, provide motivational activities, and share early warnings about heat waves. These groups include local leaders and community members who conduct workshops, door-to-door outreach, and keep records of heat-related illnesses. Second, local structural and environmental improvements like applying reflective or lime paints, adding shading to roofs and facades, solar panels, community planting for shade, enhancing ventilation with windows or wind catchers, and other external modifications. Communities will share the cost and effort of these improvements to encourage ownership. Participants will answer questions about their health, living conditions, and coping strategies. Small temperature sensors will be placed in homes, and some may wear wristbands that track sleep and heart rate. Researchers will measure the number of heat-related illnesses over 24 months and assess quality of life at several points during the study. This includes monitoring indoor temperatures, sleep quality, and comfort to find affordable ways to help families stay safe during extreme heat. The total study duration includes ongoing community activities and monitoring over two years.