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Found 7 Actively Recruiting clinical trials
Actively Recruiting
This research aims to evaluate the effect of a mobile health mHealth intervention on birth outcomes in pregnant women attending an antenatal care clinic in Nepal. The study focuses on the challenges of neonatal and infant mortality, low birth weight, and preterm birth, particularly in low and middle-income countries. It highlights the role of mHealth technologies in supporting maternal and newborn health by providing educational resources and reminders. The study involves a two-arm parallel randomized controlled trial. Pregnant women between 13 and 27 weeks of gestation will be randomly assigned to either the intervention group or the control group. The intervention group will receive standard care plus access to tailored educational videos on pregnancy care via smartphone, SMS messages, and reminder phone calls to encourage repeated viewing. The control group will receive standard care along with a control video and reminder phone calls. The study includes an initial qualitative phase to develop and validate the educational video based on pregnant womens preferences and needs. Participants will be followed from enrollment until 24 hours after childbirth. Data collection includes questionnaires assessing pregnancy care knowledge and birth outcomes such as birth weight and gestational age at delivery. Follow-up will involve post-intervention knowledge assessment about one month after initial video viewing and birth outcome assessment within 24 hours of delivery. The study aims to provide insights into how mHealth interventions might improve birth outcomes in this setting.
Actively Recruiting
Community Health Worker Led Program to Prevent and Control Hypertension Effectiveness Trial in Nepal
This research aims to assess a community health worker-led hypertension prevention and control program CHPC in central Nepal. It focuses on implementation outcomes like reach, adoption, fidelity, and maintenance at patient, provider, and health system levels. The study also compares the effectiveness of the CHPC program against a facility-based intervention in controlling systolic blood pressure and examines implementation costs and cost-effectiveness. The intervention involves trained female community health volunteers FCHVs who conduct group meetings or home visits every three months over a year. These sessions include blood pressure measurement, counseling on lifestyle changes, goal setting, medication adherence, and referral to health facilities when needed. The study uses a cluster-randomized trial design with an intervention group receiving CHPC and a control group receiving usual care based on facility visits. Participants will engage in four follow-up meetings or visits over 12 months where blood pressure and lifestyle factors are assessed. Researchers will collect data through surveys, blood pressure and anthropometric measurements, observations, and interviews. They will evaluate program adoption, reach, implementation quality, maintenance, blood pressure control, awareness, physical activity, diet, medication use, equity, scalability, and cost-effectiveness over 12 to 24 months.
Actively Recruiting
Healthy Volunteer
Researchers are estimating the prevalence of high-risk human papillomavirus HR HPV infections among girls and women aged 9 to 50 years across eight countries in South Asia and sub-Saharan Africa. This study aims to understand HPV infection rates in low socio-economic populations and specific sub-groups, including sexually active young women, by conducting cross-sectional surveys and longitudinal studies. Additionally, qualitative sub-studies will explore how gender norms and stigma affect HPV burden and access to prevention and treatment services. The study uses a harmonized protocol across all participating countries with country-specific adaptations. Cross-sectional surveys will collect urine samples from girls and women in urban and rural areas to estimate HPV prevalence. Longitudinal studies will follow sexually active girls and women aged 15 to 35 years over 24 months, collecting vaginal swabs and urine samples to measure persistent HPV infection. Qualitative studies will include interviews and focus groups to understand social factors influencing HPV risks and healthcare access. Participants will provide samples and answer standardized questionnaires on demographics, sexual and reproductive history, HPV vaccination, cervical cancer screening, and related attitudes. Testing will occur at enrollment and every six months for two years in longitudinal studies. Researchers will monitor HPV infection rates, assess questionnaire responses, and analyze laboratory results. The study includes safety follow-up and detailed data collection to provide comprehensive insight into HPV prevalence, incidence, and social influences in these populations.
Actively Recruiting
Hypertensive disorders during pregnancy HDP and gestational diabetes GDM are common complications that can cause serious health problems for mothers and babies. Researchers are studying the MOM-HD program, a mobile app-based telemonitoring system, to see if it helps women with HDP and GDM manage their blood pressure and blood glucose better. This study is a randomized controlled trial conducted in real-world hospital settings in Nepal, aiming to assess both the effectiveness and how well the program can be implemented in clinical care. The MOM-HD program includes training for patients and their families, provision of blood pressure monitors and glucometers, and a mobile app for uploading daily readings. Participants also have biweekly tele-visits with nurses who review their data and provide counseling. The study compares standard antenatal care alone to standard care plus the MOM-HD program, from enrollment during pregnancy up to 6 weeks after delivery. The program also involves ongoing technical support, financial assistance for home monitoring, and provider feedback to support sustained use. Participants will be followed from 24 to 30 weeks of pregnancy until 6 weeks postpartum. Researchers will monitor clinical outcomes such as blood pressure and blood glucose levels, and adverse perinatal events like neonatal intensive care admissions and cesarean deliveries. The study collects data through the app and provider portal, with regular telehealth check-ins, and evaluates implementation success and costs. Total participation lasts from enrollment in late pregnancy through the postpartum period, allowing comprehensive assessment of both health and program impact.
Actively Recruiting
Researchers are studying postpartum preeclampsia, a condition causing significant health issues after delivery. This trial aims to evaluate the use of biomarkers, specifically the soluble fms-like tyrosine kinase-1 and placental growth factor sFlt-1PlGF ratio, to predict new onset postpartum preeclampsia in patients who were normotensive during pregnancy. The study is a pilot randomized controlled trial focused on early detection and management of postpartum preeclampsia in high-risk individuals. Participants will have their sFlt-1PlGF ratio tested before delivery to assess preeclampsia risk. Those with low-risk ratios will receive routine postpartum care, while high-risk participants will be randomly assigned to either an intervention group receiving a bundle of care that includes remote blood pressure monitoring, education, and antihypertensive medication nifedipine ER for managing mild blood pressure elevations, or to standard postpartum care. The study will measure feasibility, effects on hypertension-related healthcare needs, and the predictive ability of the biomarker ratio. Participants will be monitored through remote blood pressure checks and clinical assessments postpartum. Data on recruitment, retention, adherence, and acceptability will be collected over one year to assess study feasibility. Secondary outcomes include hypertension-related complications within four weeks after delivery, and the predictive accuracy of the biomarker ratio two weeks postpartum. Participants remain enrolled in the study for ongoing evaluation, with the study completing in June 2027.
Actively Recruiting
Urinary incontinence UI is a common condition among women that causes involuntary urine leakage and can affect quality of life, social interactions, and mental health. This research aims to evaluate the effectiveness of pelvic floor muscle training PFMT for UI among Nepalese women, addressing a gap in local studies and adapting assessment tools for the Nepali language. The study will compare education alone versus education combined with PFMT to better understand treatment options for UI in this population. Participants will first receive education about UI, pelvic floor muscles, and lifestyle advice, including techniques like the knack and weight management. Then, women will be randomly assigned to either only receive education or education plus a supervised PFMT program consisting of twelve weekly face-to-face sessions. The PFMT exercises will be personalized using observation, vaginal palpation, and a manometer device to guide contraction strength and duration. Participants will also be encouraged to perform daily exercises at home and keep an exercise diary. Participants will be involved for one year, with assessments at baseline, 12 weeks, 6 months, and 12 months. The main measure is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form ICIQ-UI SF. Additional evaluations will assess self-efficacy in performing PFMT and muscle contraction strength using a rating scale and manometer. Data collected will help develop future guidelines for managing UI in Nepalese women.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the effectiveness of video-based health education for adults with diabetes mellitus who are receiving insulin therapy. The study aims to improve patients knowledge and practice of proper insulin injection techniques, which are essential for safe and effective diabetes management. This randomized controlled trial addresses the need for improved patient education to support treatment adherence and enhance overall health outcomes for diabetes patients. Participants will be randomly assigned to one of two groups an intervention group receiving both video-based health education and usual care, or a control group receiving only the usual care provided at Dhulikhel Hospital. The video education is guided by the Health Belief Model and includes information about insulin types, administration techniques, and storage. The study involves an open-label design with block randomization and takes place over several months. During the study, participants will undergo assessments before and after the intervention to measure their knowledge and practice of insulin therapy techniques. Data collection includes interviews and questionnaires, lasting around 30 to 35 minutes at baseline. Researchers will monitor the participants progress over a 4-month period to evaluate the impact of the video-based education. The outcomes focus on improving patients skills and understanding to promote better diabetes management and quality of life.