Marseille 13, France
Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause
Vasomotor symptoms that occur in the peri-menopausal and postmenopausal period are experienced by 80% of women and can greatly affect the quality of life by temporarily interrupting daily activities. These symptoms are experienced early in our study population who are induced to early menopause by undergoing surgical procedures such as total abdominal hysterectomy plus bilateral salpingo-oophorectomy. Due to the controversy that exists about the use of hormone replacement therapy, in recent years different alternative therapies have been proposed for the management of these symptoms, mainly for those patients who have contraindications for hormone therapy. For this reason, the use of non-hormonal therapy has been investigated. Since there are women who have contraindications to conventional therapy such as patients with cardiovascular and thrombosis risks, there is a need to search for new alternative therapies such as selective serotonin reuptake inhibitors, specifically paroxetine, so with our study we seek to evaluate how effective paroxetine is in reducing vasomotor symptoms and thus provide an alternative to this type of patients.
Phase
2Span
35 weeksSponsor
Universidad Nacional Autonoma de HondurasTegucigalpa, Francisco Morazán
Recruiting
Healthy Volunteers
Cosmetic Results With Tissue Adhesive vs. Subdermal Sutures in Cesarean Section
In Honduras, as in many parts of the world, cesarean section is a common obstetric practice. The choice of wound closure method in this procedure has significant implications not only in terms of the patient's physical health, but also in her psychological and aesthetic well-being. The scar resulting from a cesarean section can have a lasting impact on a woman's perception of her own body, affecting her self-esteem and quality of life. Historically, in Honduras, the use of subdermal sutures with nylon thread has been preferred for the closure of post-cesarean section wounds. However, with advances in medical technology, tissue adhesives have emerged as a promising alternative, potentially offering a better cosmetic outcome, faster application, and more comfortable recovery for the patient. This study is crucial in the Honduran context for several reasons: 1. improved Cosmetic Outcomes and Patient Satisfaction: By comparing two methods of wound closure, this study seeks to identify the technique that offers better cosmetic results, which could significantly improve the satisfaction and psychological well-being of patients undergoing elective cesarean sections. 2. Adaptation to Local Resources: In a country like Honduras, where health resources may be limited, it is essential to optimize the use of technologies and surgical materials. This study will provide valuable information on the feasibility and efficacy of tissue adhesives compared to the traditional method, taking into account factors such as cost and availability of materials. 3. Reduction of Postoperative Complications: By evaluating and comparing the incidence of complications associated with each closure method, the study could contribute to improve surgical practices and reduce the incidence of postoperative complications, which is of great relevance in the context of public health in Honduras. 4. Impact on Resource Management in the Health System: In the context of a country with possibly limited health resources such as Honduras, it is essential to evaluate not only the clinical efficacy of surgical techniques, but also their cost-effectiveness. This study will provide information on the relative costs of the use of tissue adhesives compared to subdermal sutures, which is relevant for planning and resource allocation in the health system. 5. Fostering Research and Evidence-Based Medicine in Honduras: This study will contribute to the growing need for contextualized medical research in Honduras, promoting the practice of evidence-based medicine that takes into account local realities and the specific needs of the population. Objective: To evaluate the effects on morbidity and postoperative cosmetic outcomes of the use of tissue adhesive versus subdermal sutures in Pfannenstiel-type cesarean sections.
Phase
N/ASpan
35 weeksSponsor
Ricardo A Gutierrez Ramirez, MD, MSc, FACOGTegucigalpa, Francisco Morazán
Recruiting
Healthy Volunteers
Peanut Ball in Labor to Reduce Anxiety and Pain
The process of labor is a unique and significant experience in a woman's life, and obstetric care is constantly seeking strategies to effectively improve the experience of this crucial event. Now in response to the growing global attention to quality and respect in maternity care, the International Childbirth Initiative (ICI) has outlined "12 steps to safe and respectful maternity care, which advocate for safe and respectful maternity care". The declaration of rights of the World Health Organization (WHO) in the year 2021 highlights the urgency of "acting now for a safe and respectful childbirth", reinforcing the global commitment to respect, protect and fulfill the right to health, particularly maternal health. In this context, it emphasizes the need to ensure a positive, satisfactory and well-being experience during pregnancy and childbirth, in Honduras is part of this group of initiatives in order to promote an environment of respect for the mother at the time of childbirth. Most healthy women can give birth with a minimum of medical procedures without putting at risk the mother-child binomial, the safest delivery is the one that evolves spontaneously and in which there is no unnecessary intervention, for that is necessary health facilities that have the requirements to provide delivery care and professionals who understand what are the basic needs of women during this physiological process. For decades, peanut balls have been used as a non-pharmacological complement for labor management. So far, this non-drug strategy has shown significant advantages in several aspects, among them, pain control, anxiety reduction, improvement in maternal experience and positive influence on obstetric indicators. In the national and international context of guidelines and commitments towards safe and respectful maternal care, there is a need for a localized and specific evaluation of interventions, such as the use of the peanut balloon, to understand its efficacy in reducing anxiety and pain during labor, With the development of this study we aim to evaluate the efficacy of the use of the peanut balloon as a therapeutic intervention to reduce anxiety and pain in women during labor at Hospital Escuela Universitario in the period from June 2024 to June 2025, which could contribute to the knowledge about therapeutic practices in the obstetric context, providing solid scientific evidence on the efficacy of the use of the peanut balloon. The successful implementation of this intervention could have a positive impact on both women's experience and obstetric clinical practice, and is expected to serve to establish a protocol for the management of labor and delivery using the peanut ball.
Phase
N/ASpan
31 weeksSponsor
Ricardo A Gutierrez Ramirez, MD, MSc, FACOGTegucigalpa, Francisco Morazán
Recruiting
Healthy Volunteers
Latent Phase Membrane Stripping for Caesarean Section Reduction
There is a need to find non-pharmacological interventions that can speed up delivery to prevent maternal complications and reduce the number of caesarean sections. Maternal mortality remains one of the biggest health problems worldwide. Every day, around 830 women die worldwide from complications related to pregnancy or childbirth. In 2015, an estimated 303,000 women died during pregnancy and childbirth or after. Most of these deaths occur in low-income countries and most of them could have been prevented. The maternal mortality rate in Latin American and Caribbean countries, calculated by the Inter-Agency Group (MMEIG), shows a significant decrease as a regional average in recent years, from 88 per 100,000 live births in 2005 to 67 per 100,000 live births in 2015. At the Escuela Hospital, the availability of beds and admission criteria in the intensive care unit (ICU) are not the same. The use of this marker is questionable, since it is affected by the level of complexity of the care provided to a health setting and the organization of obstetric care. We found in our study a cesarean section rate (almost 63.2%), with no significant variation by different criteria. This finding is consistent with that reported by Nelissen et al. Due to the severity of the obstetric conditions of these patients, their pregnancy usually requires urgent action. Although cesarean section is associated with high rates of maternal morbidity and mortality compared to vaginal delivery, when clinically indicated, timely termination of pregnancy can reduce the risk of maternal-fetal death. Based on the above, this research proposes the importance of finding strategies to reduce the rate of cesarean deliveries and thus counteract the high rates of maternal morbidity and mortality. For this reason, this research is aimed at reducing the latent phase of labor through the use of the Hamilton maneuver.
Phase
N/ASpan
31 weeksSponsor
Ricardo A Gutierrez Ramirez, MD, MSc, FACOGTegucigalpa, Francisco Morazán
Recruiting
Healthy Volunteers
InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Phase
N/ASpan
362 weeksSponsor
Columbia UniversityTegucigalpa
Recruiting
Computerized Registry of Patients With Venous Thromboembolism (RIETE)
The RIETE Registry pretends the improvement of care of patients with thromboembolic disease. Very often the investigators pose serious doubts on how to manage a specific patient. Sometimes because it is a patient with thrombocytopenia, a pregnant woman, a patient with a recent cerebral bleeding or cerebral metastasis, a patient with gastroduodenal ulcer or hepatic cirrhosis. There is no clinical evidence about how the investigators should manage these patients and the investigators have to individualize its management. The bibliography available is not of much help. Only if the investigators have a database with a sufficient number of cases, they may be able to make evidence based decisions. This database on the Internet will allow the investigators to consult and obtain an immediate response when taking care of a patient who needs an individualized management. After introducing the patient the investigators will automatically obtain the data of all patients with similar clinical profiles. And this will help the investigators to identify high-risk patients and thus facilitate them preventing possible future complications.
Phase
N/ASpan
1401 weeksSponsor
Manuel MonrealTegucigalpa
Recruiting
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
Phase
1/2Span
132 weeksSponsor
Sanofi Pasteur, a Sanofi CompanyTegucigalpa
Recruiting
Healthy Volunteers
Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Phase
3Span
126 weeksSponsor
Sanofi Pasteur, a Sanofi CompanyTegucigalpa
Recruiting
Healthy Volunteers
Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Phase
3Span
117 weeksSponsor
SanofiTegucigalpa
Recruiting
Healthy Volunteers
Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics
Abstract: Children who survive severe traumatic brain injury (sTBI) live with profound impairments that alter their development and future possibilities. Worldwide, TBI is the leading cause of death and disability for children/ adolescents with the US annual incidence 6 times greater than MS, HIV/AIDS, spinal cord injury, and breast cancer combined. Our primary focus for scientific investigation is to conduct a high quality randomized controlled trial addressing a critical TBI management question: Does using a protocol with information from intracranial pressure (ICP) monitoring to direct treatment of children with sTBI improve outcomes vs an aggressive management protocol based on imaging and clinical examination alone? This follows on our adult ICP study which found no outcome differences and has occasioned re-thinking of treatment guidelines for sTBI patients >13. A separate study is essential because children are not simply small adults and some treatment approaches carry age-related additional risks. Thus, study findings will inform US and global clinical practice. This trial will be conducted in 8 Latin American pediatric ICUs where infrastructures and practice patterns are optimal for strong internal validity and resources represent trauma care in the developing world. The successful adolescent/adult BEST TRIP trial, which collected high-quality data in similar environments (cited > 900 times) underscores the feasibility of this approach. Specific Aim: In a Phase III randomized superiority trial in 428 children with sTBI from 8 Latin American pediatric trauma centers, test the effect on outcomes of management of sTBI guided by a protocol using information from ICP monitors vs. management using a protocol that uses imaging and clinical exams to guide treatment. Hypothesis #1: Children with severe TBI whose acute care treatment is managed using a protocol based on data from ICP monitoring will have significantly lower mortality and better quality of life and global outcome at 6 months post-trauma than those whose treatment is managed with a protocol based on imaging and clinical exam. The primary measure of functional recovery is the PedsQL at 6 months. A secondary measure is GOSE-Peds. Hypothesis #2: Incorporating ICP monitoring into sTBI patient care will minimize secondary complications, decrease length of stay in ICU and decrease brain-specific treatments. Specific Aim: The Investigators will train personnel in centers new to research how to conduct high-quality scientific studies, and will extend the training for the personnel with whom the Investigators have been working, solidifying previous capacity-building efforts, and initiating new efforts.
Phase
N/ASpan
254 weeksSponsor
University of WashingtonTegucigalpa
Recruiting