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NCT ID: NCT06296238 Enrolling by invitation - Clinical trials for Prenatal Exposure Delayed Effects

Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia

Start date: February 15, 2023
Study type: Observational

The goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment. Participants are the offspring of mothers in the main study entitled "Enhancing Nutrition and Antenatal Infection Treatment (ENAT)" that was conducted in the rural Amhara region of Ethiopia. In the ENAT pragmatic clinical effectiveness study, 2399 pregnant women were randomized to receive routine prenatal care, a package of enhanced nutrition interventions (balanced energy protein supplement, iodized salt, iron-folic acid and counseling), a package of enhanced infection management interventions (genitourinary tract infection screening-treatment, deworming), or a combination of both packages. The impact of these antenatal nutrition and infection interventions on birth outcomes (infant birth size and gestational length) was examined in the main study. In this longitudinal cohort study, we will follow the offspring from the ENAT pregnancy cohort up to 24 months postnatal age and assess their growth, health and neurodevelopment. The main questions it aims to answer are: 1. What are the effects of pregnancy interventions from the parent study (ENAT) on offspring neurodevelopmental outcomes? 2. What are the associations between maternal-newborn iron status and inflammation on infant neurodevelopment? 3. What are the associations between maternal iodine status and thyroid function on infant neurodevelopment? We will follow children of mothers from the parent ENAT study to monitor their growth, health, and neurodevelopment up to 24 months postnatal age.

NCT ID: NCT06273007 Recruiting - Stillbirth Clinical Trials

Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Overall Objective To introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia. Interventions 1. Locally agreed and achievable intrapartum guidelines 2. Low dose high frequency trainings (LDHF) 3. Partograph Overall Design A quasi-experimental pre-post study (PartoMa study) Setting Department of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia. Population Laboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after onset of labour and followed until discharge. Endpoints The primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below. Study Time Data collection from June 2023 to May 2025. Specific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital. iii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital. iv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital. Setting PartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000.

NCT ID: NCT06250257 Recruiting - Clinical trials for Dilated Cardiomyopathy

Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

Dilated cardiomyopathy (DCM) is a condition associated with Left and /or right ventricular (LV) dilatation and systolic dysfunction without coronary artery disease or abnormal loading circumstances proportionate to the severity of LV impairment. It is one of the leading causes of heart failure in younger adults, often requiring cardiac transplantation, and is caused by various factors, including myocarditis, alcohol, drug, and metabolic disturbances. About 35% of patients have genetic mutations affecting cytoskeletal, sarcomere, and nuclear envelope proteins. The prognosis depends on the severity and heart remodeling, with the worst outcomes in patients with low ejection fractions or severe diastolic dysfunction. Although it is more common in men, DCM also occur in women, and hence hormonal factors can play a role in the development of DCM in women. Bromocriptine has been suggested as a potential treatment option. Bromocriptine is a dopamine agonist that is primarily used to treat conditions such as hyperprolactinemia, and acromegaly. However, it has also been studied in the context of heart failure, and some studies have suggested that it may be beneficial in women with Peripartal cardiomyopathy (PPCM), a form of DCM that occurs in the last month of pregnancy or up to five months postpartum. The mechanism by which bromocriptine may improve left ventricular function in DCM is not fully understood, but it is thought to be related to its ability to reduce prolactin levels. Prolactin is a hormone that has been shown to be elevated in some cases of DCM, and it may contribute to the development and progression of the condition. To date, the use of bromocriptine is recommended for the treatment of pregnancy-related cardiomyopathy (PPCM) due to a significant increase in prolactin levels. However, prolactin level may increase during menstrual cycles of reproductive-age women, which candidates the use of bromocriptine in women of all reproductive ages. The aims of this study is to assess the use of bromocriptine in terms of LV function improvement, overall improvement of heart failure symptoms and reduced mortality and improved quality of life, in dilated cardiomyopathy among women of reproductive age.

NCT ID: NCT06242457 Completed - Clinical trials for Peutz-Jeghers Syndrome

Poorly Differentiated Adenocarcinoma of the Jejunum in a Patient With Peutz-Jeghers Syndrome: A Case Report

Start date: July 15, 2023
Study type: Observational

Our study is a case report of one of the rarest risk factor, Peutz-Jeghers syndrome, of small bowel malignancy detected in a patient with poorly differentiated adenocarcinoma of small bowel(jejunum)

NCT ID: NCT06189417 Not yet recruiting - Clinical trials for Diabetes Mellitus, Self-management Behavior and Glycosylated Hemoglobin Levels

Effect Of Health Extension Worker-Led Based Interventions on Improving Self-Management Behavior Among Diabetic Patients in Ethiopia

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Despite the existence of lifestyle interventions designed to encourage self-management behaviors, the difficulty of adhering to recommended practices remains a widespread issue globally, including in Ethiopia. Traditional approaches to care have demonstrated limited effectiveness in promoting self-management behavior. As a potential solution, a Health Extension Worker-Led club-based intervention has been implemented. Therefore, the aim of this study is to assess the impact of the Health Extension Worker-Led club-based intervention on improving self-management behaviors and glycemic control. The study will utilize a parallel-group, cluster randomized controlled trial design to investigate its objectives. The main focus of the research is to assess the average increase, both in terms of mean and percentage, in adherence to self-management behaviors and glycemic control. Additionally, the study aims to evaluating the acceptance of the intervention. To evaluate the impact of a Health Extension Worker-led intervention on self-management behavior and levels of glycosylated hemoglobin (HbA1C), a difference-in-difference analysis will be employed. A comparison of the intervention's effects across different groups will be conducted using an independent-sample t-test.

NCT ID: NCT06171503 Completed - Clinical trials for Male Reproductive Problem

Effect of Formal Letter of Invitation on Male Partner Involvement at Antenatal Care Clinic

Start date: June 22, 2022
Phase: N/A
Study type: Interventional

Prevention of mother to child transmission (PMTCT) of human immune deficiency virus (HIV) program requires great male participation in achieving a sustained reduction of mother-to-child transmission of HIV. Many strategies have been employed to promote male participation in antenatal care but few have been assessed to convey important lessons for scale-up. In Ethiopia, though there is no evidence on its effectiveness, letter of invitation has been tried as a means to promote participation of men in PMTCT program at antenatal care. The study is carried out in two public hospitals to evaluate the effect of letter of invitation delivered through mother support group counselling on male involvement at antenatal care clinic. The findings of this study will directly benefit pregnant women attending antenatal clinic in utilizing PMTCT service effectively. The formal letter of invitation proposed may be incorporated by health service provider in their routine antenatal clinic. It will also help the policy makers to give greater priority to reach and involve men, and to develop effective policies as well as programs to overcome the challenges. Thus, an increase in the uptake of PMTCT services will ultimately lead to a reduction in pediatrics HIV infection.

NCT ID: NCT06150274 Not yet recruiting - Clinical trials for Rheumatic Heart Disease

Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy

Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this randomised study is comparison of wire assisted balloon mitral valvulotomy to standard Inoue balloon technique on patients with rheumatic mitral stenosis. The main question it aims to answer is whether procedure time is reduced using the wire assisted method. Participants will be randomized to one of the two methods.

NCT ID: NCT06149572 Active, not recruiting - Clinical trials for Severty of Hpotention

Comparing Sitting Versus Lateral Position During Spinal Anesthesia on the Severity of Hypotension:

Start date: November 25, 2023
Phase: N/A
Study type: Interventional

This study aimed to assess the effect of sitting and lateral positions on the severity of hypotension during the initiation of spinal anesthesia in elective cesarean section. There will be Sitting and Lateral groups in the study.

NCT ID: NCT06148792 Not yet recruiting - Vivax Malaria Clinical Trials

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question[s] it aims to answer are: - is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days) - is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg) - is the tolerability and safety of TQRevised acceptable - is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.

NCT ID: NCT06125860 Recruiting - Preterm Birth Clinical Trials

BEP Targeting Strategies in Ethiopia

Start date: August 7, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.