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NCT ID: NCT02223806 Completed - Clinical trials for Postpartum Hemorrhage

Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration

UTAMP
Start date: April 2014
Phase: N/A
Study type: Interventional

To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal and neonatal outcomes.

NCT ID: NCT02200289 Completed - Pulmonary Function Clinical Trials

In Utero Household Air Pollution Exposure and Lung Development in Ghana

Start date: October 2014
Phase: N/A
Study type: Observational

Household air pollution from cook stoves using solid fuels dominates total population air pollution exposures. Females and young children are disproportionately affected as they either perform or are present for the majority of cooking activities. Worldwide, household air pollution is responsible for 1.6 million premature deaths annually, largely secondary to respiratory tract infections, and 2.7% of worldwide disability-adjusted life years. Children that survive childhood are not free from disease; the WHO estimates that 35% of COPD cases worldwide are secondary to household air pollution. Reducing female and infant morbidity and mortality related to household air pollution secondary to biomass smoke exposure is a top-priority public health goal. We hypothesize that in utero biomass smoke exposure results in a fetal oxidant imbalance, which negatively impacts lung development. We will leverage the success of the Ghana Randomized Air Pollution and Health Study, a randomized cook stove intervention trial of 1,415 mother-infant pairs, to examine the impact of maternal household air pollution exposure on cord blood oxidant imbalance and infant pulmonary function. We aim to enroll at least 150 infants, analyze cord blood samples for markers of oxidant imbalance and perform infant pulmonary function testing. Cord blood will also be prepared for future immune, hormonal and epigenetic testing. This study will allow us to consider interventions, such as maternal antioxidant dietary supplementation during pregnancy, to compliment existing cook stove interventions and reduce household air pollution-related morbidity and mortality.

NCT ID: NCT02199951 Recruiting - Malaria Clinical Trials

Introduction of Eurartesim® in Burkina Faso, Mozambique, Ghana and Tanzania

Start date: September 2013
Phase: Phase 4
Study type: Observational

WHO recommends the use of artemisinin-based combination therapies (ACTs) in the treatment of uncomplicated malaria to stem falciparum malaria drug resistance. New ACTs are entering the African market and will be used by the public health care system. The collection of safety data and risk evaluation through observational data are critical in order to assess risk/benefit profile of each ACT through its life cycle and providing information on the best use. Additionally there is need to assess the impact of the introduction of a new ACT in the evolution of its efficacy and malaria morbidity and mortality. Dihydroartemisinin/Piperaquine (DHA/PQP) is a new ACT approved by European Medical Agency and a number of African countries. This is a phase IV observational evaluation of the clinical safety of the fixed-dose DHA/PQP (Eurartesim®) in public health facilities within selected Health and Demographic Surveillance Centres in Burkina Faso (Nouna), Mozambique (Manhica), Ghana (Dodowa, Kintampo, Navrongo), Tanzania (Rufiji) and other African countries to be added. Eurartesim® will be used as first-line treatment of uncomplicated malaria an objective to evaluate the safety of Eurartesim® when used under usual conditions in 10,000 patients. Patients > 6 months and 5 kg except pregnant women will be enrolled and Eurartesim® administered as a single daily dose regimen over 3 days. Patients will be contacted at Day 5 (± 2 days) after treatment, to assess recovery and any adverse events.

NCT ID: NCT02185625 Completed - Clinical trials for Postpartum Hemorrhage

Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether use of the Safe Delivery smartphone application by midwives can reduce excess blood loss from bleeding, and infant death during childbirth in Ghanaian women. Moreover, it will be investigated whether the Safe Delivery application can increase midwives' knowledge and skills in managing childbirth. Fifteen hospitals in Greater Accra, Ghana, will be cluster randomized to either use the Safe Delivery application (intervention), or to no intervention (control). In the intervention hospitals, midwives will be educated in the use of Safe Delivery. Pregnant women will be enrolled at delivery and followed until 7 days postpartum. Data collection will begin July 2014 and is expected to be finished by October 2014.

NCT ID: NCT02153034 Active, not recruiting - Buruli Ulcer Clinical Trials

Pathogenesis and Management of M. Ulcerans Disease, Buruli Ulcer

Buruli_Path
Start date: May 2013
Phase: N/A
Study type: Observational

Buruli ulcer is a neglected tropical disease caused by infection with Mycobacterium ulcerans (Mu) in rural parts of West Africa. It causes large skin ulcers mainly in children aged 5 to 15 years. Access to treatment is limited and many cases present late. There have been major advances in understanding the mechanism of disease together with improved diagnosis and management. The aim of the proposed studies is to identify markers predictive of a rapid response to antibiotic treatment and to investigate the pathogenesis of paradoxical reactions and oedematous lesions in Mu disease. Infection with Mu results in a nodule under the skin which enlarges and breaks down to form an ulcer. This is because Mu produces a toxin that spreads outwards and damages subcutaneous tissue. In recent years it has been found that antibiotic treatment for 8 weeks with daily tablets and intramuscular injections heals ulcers. This is unpleasant and it would be better if the treatment could be shortened. Our previous studies suggest this may be possible. Therefore a wide range of tests will be investigated in order to identify markers for people in whom the infection is at an early stage with low numbers of Mu bacteria and low levels of toxin in the skin. During antibiotic treatment the rate of healing will be measured to find out which markers are the most reliable. In some patients new areas of inflammation develop despite treatment and this is called a paradoxical reaction. The immune response to Mu will be investigated serially during antibiotic treatment to investigate the cause of paradoxical reactions. About 15% of patients have oedematous disease, the most severe form of Buruli ulcer. We will study the amount of Mu toxin produced by the strain of Mu cultured from patients with this form of the disease. Hypothesis - Buruli ulcer patients that heal rapidly/slowly or develop paradoxical reactions with treatment will have associated predictive viability or serum biomarkers. - Buruli ulcer patients with oedematous disease are associated with larger amounts of mycolactone and viable organisms

NCT ID: NCT02150980 Completed - Clinical trials for Fractures or Dislocations

INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)

INORMUS
Start date: April 2014
Phase:
Study type: Observational

Background: Worldwide, injuries from trauma represent a major public health problem. The World Health Organization (WHO) has deemed this problem as one of the most important global priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is little empirical data in low and middle-income countries quantifying the burden of musculoskeletal injuries. Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The primary objective of the study is to determine the mortality, re-operation and infection rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and Latin America.

NCT ID: NCT02118428 Completed - Malaria Clinical Trials

Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria

AIMS
Start date: March 2014
Phase: N/A
Study type: Interventional

The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole Blood to prevent Malaria transmission by transfusion of whole blood.

NCT ID: NCT02111902 Withdrawn - Obesity Clinical Trials

Vitamin D Ancillary Study in 5 Populations of African Origin

VIDA
Start date: September 2011
Phase: N/A
Study type: Observational

The availability of data on plasma 25-Hydroxyvitamin D (25(OH)D) concentrations in the last two rounds of the National Health and Nutrition Examination Survey (NHANES) has generated a high level of interest in the consequences of 25(OH)D deficiency and in particular its potential impact on black Americans. Fundamental new questions about the biology of vitamin D have now come to the fore. Are low 25(OH)D-intact parathyroid hormone (iPTH) levels a physiologic "abnormality" in African Americans or does the 25(OH)D-iPTH system have sufficient plasticity to adapt to low sunlight exposure? Could the low 25(OH)D levels which result from the "gene- environment discordance" observed in dark skinned populations in the US be a risk factor for metabolic disorders? Ultimately, the public health community and regulatory bodies must offer recommendations for optimal levels and supplementation. The investigators propose to utilize cohorts from an ongoing NIH-funded study designed to identify determinants of weight change and cardiovascular disease risk in five Afro-origin populations [Modeling the Epidemiologic Transition Study (METS)] to examine these questions. The five METS countries include Ghana, Seychelles, South Africa, Jamaica and the US; the five populations differ greatly in terms of sun exposure and dietary intakes. In addition to the extensive energy expenditure, dietary intake and obesity-related metabolic markers being measured in METS, the investigators propose to assess plasma 25(OH)D, iPTH, serum and urinary calcium, plasma markers of bone resorption and formation, and quantitative ultrasound of the calcaneus. The associations of adiposity, weight change, cardiovascular disease (CVD) risk factors such as blood pressure and insulin, and bone strength with 25(OH)D and iPTH will be assessed. The proposed study will provide a comprehensive assessment of the distribution and determinants of 25(OH)D-iPTH and related physiologic measures across a wide range of latitude and lifestyles. These data should contribute substantially to the understanding of the "normal" range within which these hormones function and their significance in Afro- origin populations.

NCT ID: NCT02088528 Recruiting - Glaucoma Clinical Trials

The Ghana Primary Tube Versus Trabeculectomy Study

GPTVT
Start date: March 2014
Phase: N/A
Study type: Interventional

Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of medications, disease severity and poor compliance. Surgical treatment is likely to be a more practical solution. The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical study.

NCT ID: NCT02085850 Enrolling by invitation - Glaucoma Clinical Trials

Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort

Start date: March 2014
Phase: N/A
Study type: Observational [Patient Registry]

Aim 1: To determine the incidence of glaucoma in Ghana in subjects previously found to be non-glaucomatous in the Tema Eye Survey. Aim 2: To characterise the progression of glaucoma and the outcomes of subjects diagnosed with glaucoma in the Tema Eye Survey.