There are about 347 clinical studies being (or have been) conducted in Nigeria. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Even though, the African-American Heart Failure Trial (A- HeFT) demonstrated that a combination ISDN and HYD (BiDil) improved survival among African-American patients with HF, when compared to placebo, there is no trial on chronic heart failure patients secondary to hypertensive heart disease which is the commonest etiological factor for heart failure in sub-Saharan Africa. A previous study (The Bi treatment with hydralazine/nitrate versus placebo in Africans admitted with acute Heart Failure (BAHEF) which was on acute heart failure patients with varying aetiology, was under powered as the study could not achieve the estimated sample size because of logistic issues. We therefore are trying to determine the feasibility of a randomised, open-label, parallel group, two-arm, superiority trial of ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA.
ABSTRACT BACKGROUND: Labor pain is one of the most excruciating pain experienced by women. It affects maternal psychology and the course of labor causing apprehension, anxiety, and stress. Therefore there is a need for a safe and effective analgesic with minimal maternal and fetal side effects like intravenous paracetamol which has been shown to have great analgesic effect in labour with minimal maternal and neonatal side effects. OBJECTIVE: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs. METHOD: This would be a hospital based randomized controlled trial comparing intravenous paracetamol to intramuscular tramadol as labour analgesia in pregnant women in active phase of labour in the department of obstetrics and gynecology at Alex-Ekwueme Federal University Teaching Hospital and St. Patrick Mile 4 hospital, Abakaliki. A total of 194 pregnant women in active phase of labour will be included in study after fulfilling the inclusion criteria. These women will be divided into 2 groups of 97 each. Group A will receive a 100ml intravenous infusion containing 1000mg of paracetamol single dose over 15min. Group B: will receive intramuscular tramadol hydrochloride 100mg single dose. Pain intensity of women with both drugs will be noted before administration of drug, one hour, two hours and three hours after administration of drug using the visual analog scale. Perinatal outcome will also be recorded. 10 ANALYSIS AND RESULTS: Data will be collated, tabulated and then statistically analyzed using Statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables will be presented as mean and standard deviation (Mean ± 2SD) or median and range as appropriate, while categorical variables will be presented as frequencies and percentages. Chi-square test( or Fisher's exact test where applicable) will be used for comparison between groups for categorical variables while student t test or Mann-Whitney U test will be used for comparison between groups for continuous variables KEYWORDS Labour analgesia, intravenous paracetamol, intramuscular tramadol, visual analog scale, neonate, side effects.
Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term Prelabour Ruptuture of Membranes.
Episiotomy is the commonest surgical procedure performed on parturient. It is usually associated with perineal pain which is particularly severe in the first 24 hours post repair. Perineal pain after episiorrhaphy if not adequately managed puts the woman into painful distress thus preventing good immediate post-partum care for the newborn. The aim is to compare the efficacy of single dose rectal diclofenac with oral diclofenac for the relief of perineal pain within 24 hours after episiotomy repair at Alex Ekwueme Federal University Teaching Hospital Abakaliki.
Maternal infectious morbidity is a common complication of cesarean delivery, especially in a poor recourse setting like ours. This study was done to compare the effectiveness of preoperative vaginal cleansing with immediate postoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean infectious morbidities. Randomized trial involving 120 consented women who had elective or emergency cesarean sections at term, 60 in each group. Group 1 had preoperative while group 2 had postoperative vaginal cleansing with 1% chlorhexidine.
Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that contributes substantially to maternal and perinatal morbidity and mortality, especially in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria. To compare the efficacy of loading dose of magnesium sulphate with that of the Pritchard regimen in the prevention of eclampsia in severe preeclampsia and recurrent fits in eclampsia in a low resource setting. A prospective, single blinded randomized controlled study of loading dose versus Pritchard regimens of MgSO4 at the Teaching Hospital Abakaliki. One hundred and twenty patients were recruited 60 to each arm using computer-generated numbers. Sociodemographic characteristics, efficacy and adverse effects of the drug on the mother and baby were noted.
Background: Intimate partner violence is arguably the most prevalent, persistent and pernicious type of violence against women, all around the world. It also has significant repercussions for women's health, yet, in some parts of the world, considered an acceptable practice within intimate partner relationships. Community-based interventions, on the other hand, offer promises as a strategy that can get community members involved in working to prevent IPV. This study evaluated a community mobilisation intervention to challenge attitudes toward IPV and prevent violence within intimate relationships. Methods: This mixed-method randomised community trial was conducted in selected rural communities in Oyo State, Nigeria, between January 2018 and April 2021. It employed a six-month community mobilisation intervention focused on creating awareness and challenging harmful social norms relating to IPV. In-depth interviews, focus group discussions and two cross-sectional surveys were conducted among men and women of reproductive age who were married at baseline and end line to estimate changes in key outcomes. Difference-in-difference regression models were estimated to compare changes in IPV levels in the intervention and control arms. Conclusion: This trial should demonstrate the effectiveness of community mobilisation interventions to change attitudes supportive of IPV and prevent women's experience of IPV.
The benefits of pre-incision skin antisepsis is well established. However, the role of skin antisepsis after skin closure in abdominal surgery for sepsis is not well reported. This study examined whether the use of skin antisepsis after closing the skin during a surgery for an infection within the abdomen would have an effect on wound infection in the post-operative period. The patients - aged 18 years and above - were categorised into two groups: the first had antisepsis with povidone iodine-soaked gauze while the second group of patients had their wound only dressed with a dry sterile gauze. Both groups were then compared for the occurrence of surgical site infection and other post-operative outcomes. The null hypothesis was that intra-operative skin antisepsis after skin closure following abdominal surgeries would have no effect on the incidence of post-operative Surgical Site Infection while the alternative hypothesis was that intra-operative skin antisepsis after skin closure following abdominal surgeries would have an effect on the incidence of post-operative Surgical Site Infection.
The study will be a randomized controlled trial. The aim of the study is to determine the Breast Cancer (BC) risk and to evaluate the effect of BC risk counseling on lifestyle changes and adherence to risk-reduction practices among first-degree female relatives of BC patients in South-West Nigeria. This study's research questions are: - What are the Nigeria Breast Cancer Study (NBCS) and Gail models estimates of the BC risk of first-degree female relatives of BC patients in South-West, Nigeria? - What are the effects of BC risk assessment and counseling on adherence to breast screening recommendations among first-degree female relatives of BC patients in South-West, Nigeria? - What are the effects of BC risk assessment and counseling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of BC patients in South-West, Nigeria? - What is the knowledge, attitudes, and perception of first-degree female relatives of BC patients in South-West Nigeria towards genetic testing and BC etiology? - What factors predict breast screening among first-degree female relatives of BC patients in South-West Nigeria? - What factors predict the time to first BC screening (post-intervention) among first-degree female relatives of BC patients in South-West Nigeria? Participants will be randomized into the control arm (standard care) and intervention arms of the study. The intervention arm of the study will have a BC risk assessment followed by individualized BC risk counseling. In addition, the intervention arm will receive BC awareness and MammaCare® BSE training. The control arm will receive only standard care comprising BC awareness and MammaCare® BSE training. Both study arms will receive BC screening recommendations and lifestyle modification recommendations. We hope that the BC risk counseling will improve BC screening practices and modification of risk behaviors and this hypothesis will be tested.
This study assessed and compared the effects of clinic-based and telemonitored home-based interventions on pain intensity, function and quality of life in patients with knee osteoarthritis (KOA). This was with a view to providing evidence for the validation of the effectiveness of home-based intervention on knee osteoarthritis