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<|newrecord|> nctId: NCT06377527 id: 2023-0945 id: NCI-2024-03342 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA) overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2035-12-28 date: 2037-12-28 date: 2024-04-22 date: 20... |
<|newrecord|> nctId: NCT06377514 id: PCOL109PHNG briefTitle: Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-10-31 date: 2025-10-31 date: 2024-04-22 date: 2024-04-22 name: Johnson & Johnson Surgical Vision, Inc. class: INDUSTRY briefSu... |
<|newrecord|> nctId: NCT06377501 id: 804687 briefTitle: Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL) overallStatus: RECRUITING date: 2023-03-07 date: 2024-07-01 date: 2024-07 date: 2024-04-22 date: 2024-04-22 name: University of California, San Diego class:... |
<|newrecord|> nctId: NCT06377488 id: CR-6542 briefTitle: Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-06-24 date: 2024-06-24 date: 2024-04-22 date: 2024-04-22 name: Johnson & Johnson Vision Care... |
<|newrecord|> nctId: NCT06377475 id: 2024-00148 id: 2024-00148 type: REGISTRY domain: EKNZ briefTitle: Fabrication and Insertion of Michigan Splints by Dental Students overallStatus: ENROLLING_BY_INVITATION date: 2024-03-08 date: 2024-05 date: 2025-12 date: 2024-04-22 date: 2024-04-22 name: Juliana Marotti Großhausen c... |
<|newrecord|> nctId: NCT06377462 id: VEXAS-Registry briefTitle: Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection overallStatus: RECRUITING date: 2024-03-13 date: 2029-12-31 date: 2030-12-31 date: 2024-04-22 date: 2024-04-22 name: Technische Universität Dresden class: OTHER... |
<|newrecord|> nctId: NCT06377449 id: UIL-CSP-18052023 briefTitle: Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2026-01-01 date: 2024-04-22 date: 2024-04-22 name: Saint Petersburg State... |
* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods. |
* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ul... |
Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly imp... |
<|newrecord|> nctId: NCT06377436 id: PRAISE briefTitle: Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme acronym: PRAISE overallStatus: RECRUITING date: 2023-03-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-22 date: 2024-04-22 name: Unive... |
The expected outcome is to slow down a functional decline not only in isolation in the domains trained by the program. conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Experimental trainin... |
<|newrecord|> nctId: NCT06377423 id: A54678775 briefTitle: Comparison Between Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases overallStatus: COMPLETED date: 2021-08-01 date: 2024-01-01 date: 2024-01-10 date: 2024-04-22 date: 2024-04-22 name: Prince Sattam Bin Abdulaziz Universi... |
<|newrecord|> nctId: NCT06377410 id: FF-2023-433 briefTitle: Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients acronym: SyProNAC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-30 date: 2026-11-30 date: 2024-04-22 date: 2024-04-22 name: National University of Ma... |
Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the con... |
Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera h... |
<|newrecord|> nctId: NCT06377397 id: IIRPIG-2023-0000070 briefTitle: Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates acronym: SAUNA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2028-04-14 date: 2024-04-22 date: 2024-04-22 name: Indian Council of... |
The goal of this research study is to find out: |
1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life. |
2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life. |
3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes"). conditions: Sepsis conditions: PROM, Preterm (Pregnancy) conditions: Early-Ons... |
1. Group 1: Intervention group (Selective antibiotic group) |
2. Group 2: Comparison group (Universal antibiotic group) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Project staff, nurses and resident doctors looking after the neonate will not be blinded. The assessment of the primary outcome will be performed by a blinded adjudicator, who is not involved in the r... |
<|newrecord|> nctId: NCT06377384 id: DHP-33-FLIGHT briefTitle: FLIGHT Study for Childhood Chronic Illness overallStatus: RECRUITING date: 2022-04-20 date: 2025-09 date: 2025-09 date: 2024-04-22 date: 2024-04-23 name: Documenting Hope Project class: OTHER briefSummary: The FLIGHT study is an open-label, single-arm, pilo... |
<|newrecord|> nctId: NCT06377371 id: 23-03025815 briefTitle: Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-22 date: 2024-04-22 name: Weill Medical College of Cornell University class: OTHER name: Curium ... |
<|newrecord|> nctId: NCT06377358 id: CEEAH CA31 briefTitle: Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy. overallStatus: COMPLETED date: 2022-05-09 date: 2022-07-25 date: 2023-06-22 date: 2024-04-22 date: 2024-04-22 name: CAPENERGY MEDICAL, SL class: INDUSTRY name: University of Malaga name: Alfonso X... |
20 obese patients will be treated with Tecar Therapy (Radiofrequency). Each patient will have 4 active, automatic plates placed on the abdomen (200 cm2 per plate), two on the right side of the midline and two on the left side. Energy will be applied for 50 minutes, controlling the temperature. Subsequently, 15 minutes ... |
Subcutaneous and visceral fat will be measured by MRI. Anthropometric variables (Body Mass Index, Waist to Hip ratio and skinfold) will be also measured. |
Metabolic and inflammatory effects of the RF treatment will be evaluated measuring adipokines (Leptin, adiponectin and resistin) as well as citokines (IL-6, TNF-a and C reactive Protein). |
Results will be analyzed using the SPSS statistics package. A Kolmogorov-Smirnov test will be applied, if the data behaves normally, parametric tests will be applied. If not, non-parametric tests will be performed. The differences between proportions will be analyzed using Fischer's exact test. The differences between ... |
<|newrecord|> nctId: NCT06377345 id: 202312-00011 briefTitle: Remote Patient Monitoring Solution for Chronic Respiratory Disease Management overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-12-31 date: 2025-03-30 date: 2024-04-22 date: 2024-04-22 name: SingHealth Polyclinics class: OTHER briefSummary: Aim: ... |
Methodology: Using a randomized controlled trial design, this project aims evaluate the effectiveness of AeviceMD in improving patients' outcomes in terms of reducing exacerbation, healthcare utilization, improving quality of life, self-efficacy, and cost effectiveness. Paediatric patients above age 7 and adults will b... |
Importance of study: This study will evaluate if the AeviceMD can help improve disease management and reduce recurrence of asthma exacerbation. |
Potential benefits and risk: AeviceMD allows for remote monitoring and tracking of patients' lung sounds, which could be used by patients to monitor their lung condition and prevent an episode of exacerbation or worsening exacerbations culminating in an admission which who further utilize already limited healthcare res... |
<|newrecord|> nctId: NCT06377332 id: X23-0330 briefTitle: Biomarkers of Dementia in Chronic Sleep and Breathing Disorders acronym: ORACLE overallStatus: RECRUITING date: 2023-12-01 date: 2025-07-01 date: 2025-07-01 date: 2024-04-22 date: 2024-04-22 name: Woolcock Institute of Medical Research class: OTHER briefSummary:... |
Chronic breathing disruptions and poor sleep may lead to cognitive impairment and brain changes linked with early neurodegenerative processes. As such, identifying early markers of cognitive impairment and dementia risk in individuals with chronic respiratory and sleep breathing disorders is crucial for understanding h... |
<|newrecord|> nctId: NCT06377319 id: 101080905 briefTitle: Decision Support System for Diagnosis and Progression of Heart Failure acronym: STRATIFYHF overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-31 date: 2027-07-31 date: 2024-04-22 date: 2024-04-23 name: Coventry University class: OTHER name: Newcas... |
<|newrecord|> nctId: NCT06377306 id: MC study briefTitle: Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes overallStatus: RECRUITING date: 2023-11-05 date: 2026-01-30 date: 2027-01-30 date: 2024-04-22 date: 2024-04-22 name: Wingate Institute class: ... |
The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes. |
200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC. |
Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment. conditions: Menstrual Cycle conditi... |
<|newrecord|> nctId: NCT06377293 id: FEMH-IRB-TSAI2024 briefTitle: Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2025-12 date: 2029-06 date: 2024-04-22 date: 2024-04-23 name: Far Eastern Memorial Hospital class: OTHER br... |
<|newrecord|> nctId: NCT06377280 id: NAV-0011 briefTitle: En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device. overallStatus: RECRUITING date: 2024-01-18 date: 2024-10 date: 2024-12 date: 2024-04-22 date: 2024-04-22 name: Wellspect HealthCare class: INDUSTRY briefSummary: This is an un-controlled... |
Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be perf... |
<|newrecord|> nctId: NCT06377267 id: ESR-20-21103 briefTitle: Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial) acronym: STROBE overallStatus: RECRUITING date: 2024-02-06 date: 2024-04 date: 2025-09 date: 2024-04-22 date: 2024-04-22 name: Vall d'Hebron Institute of Oncolo... |
The study aims to address the challenge of accurately identifying patients with ovarian cancer who would benefit from poly-ADP ribose inhibitors (PARPi) as first-line maintenance therapy. While BRCA1/2-mutated epithelial ovarian cancer (EOC) patients have shown significant benefits from PARPi treatment, the efficacy in... |
Summary: |
The study is a prospective, non-randomized trial designed to evaluate the concordance of the VHIO-CARD-300 test in establishing HR status compared to SOPHiA DDM™ Dx HRD Solution. Additionally, it aims to assess the association between HRD status determined by the VHIO-CARD-300 test and treatment efficacy. Patients with... |
<|newrecord|> nctId: NCT06377254 id: BB/X015173/1 briefTitle: Multi-organ Responses to CHronic Physical Activity and INactivity acronym: CHAIN overallStatus: RECRUITING date: 2024-03-12 date: 2027-12-17 date: 2028-10-31 date: 2024-04-22 date: 2024-04-22 name: University of Nottingham class: OTHER name: Biotechnology an... |
Persistent physical inactivity is thought to be a key contributing factor to the risk of poor health and functional decline occurring in middle-aged and older adults. It is therefore concerning that most middle-aged adults spend \>8hrs/day being sedentary, with average step count of 3000-4000 steps/day. |
To be able to holistically assess the effectiveness of future strategies to address age-related decline in health, and devise public health messages to help individuals reach older age in better health, it is essential that the complex physiological effects that activity and inactivity have across biological systems ar... |
The goal of this intervention study is to compare the impact of physical activity and inactivity on body functioning. Twenty moderately active participants will decrease their physical activity for six months to match the average amount carried out by middle-aged people in the UK. They will then undertake 3-months of r... |
Before and at points during the intervention period, participants will be asked to make some measurements at home and attend the University of Nottingham to have multiple assessments made. These include; |
* fitness, muscle strength and function tests, |
* completion of questionnaires and computer-based brain puzzles |
* having muscle and fat tissue biopsies and blood samples taken. |
* The study also involves having MRI scans. |
This 5-year study will commence in January 2024, with participant recruitment starting in March 2024 and finishing in May 2027. conditions: Sedentary Behavior conditions: Metabolic Syndrome conditions: Age-related Cognitive Decline conditions: Age-Related Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: NON_... |
<|newrecord|> nctId: NCT06377241 id: 2023-1436 id: A536000 type: OTHER domain: UW Madison id: SMPH/OPHTHAL&VIS SCI/GEN type: OTHER domain: UW Madison id: Protocol Version 2/23/2024 type: OTHER domain: UW Madison briefTitle: ScentAware and OCT in MCI vs HC overallStatus: RECRUITING date: 2024-04-15 date: 2024-06 date: 2... |
* Whether the test is as effective and reliable as the standard test |
* Whether there is a link between the results of the smell test and the structure of the back of the eye |
Participants will: |
* complete a short questionnaire |
* have pictures of the inside of their eyes taken |
* perform two smell tests conditions: Alzheimer Disease, Early Onset studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: ScentAware name: UPSIT measure: Compare test scores of ScentAware olfactory test to the scores of the University of Pennsylvania Smell Ide... |
<|newrecord|> nctId: NCT06377228 id: TAK-007-1001 briefTitle: A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2029-04-23 date: 2029-04-23 date: 2024-04-22 date: 2024-04-22 name: Takeda class: INDUSTRY briefSummary: The main aim of the study is t... |
Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007. conditions: Refractory Lupus Nephritis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SI... |
<|newrecord|> nctId: NCT06377215 id: Pro00041729 id: R01DC020514 type: NIH link: https://reporter.nih.gov/quickSearch/R01DC020514 briefTitle: Understanding Aided Speech Perception in Noise overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-03-01 date: 2028-03-01 date: 2024-04-22 date: 2024-04-22 name: Univer... |
<|newrecord|> nctId: NCT06377202 id: SynKIR-110 LTFU briefTitle: Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies overallStatus: RECRUITING date: 2023-11-15 date: 2038-12-15 date: 2038-12-15 date: 2024-04-22 date: 2024-04-24 name: Verismo Therapeutics class: INDUSTRY briefSummary: ... |
<|newrecord|> nctId: NCT06377189 id: 2023-01910 briefTitle: Psychiatric Consultation-Liaison Intervention in Primary Care: A Pilot Study acronym: PLIMeC-P overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-22 date: 2024-04-22 name: Center for Primary Care and Public Healt... |
Primary Care Physicians (PCPs) have a key role in preventing, detecting, and managing mental disorders. Therefore, the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges. It is well demonstrated that multidisciplinary i... |
The mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings, for newly reported mental illness, versus a Treatment As Usual (TAU) control arm. The intervention consists of a CL-psychiatric intervention into private medical practices, provi... |
The pilot study (PLIMeC-P) will determine whether the main planned study (PLIMeC) is feasible and practicable. It will be conducted on two sites, the Neuchâtel Psychiatry Centre (CNP) and the North-west Adult Psychiatry Service (SPANO), Department of Psychiatry of CHUV, Yverdon. For the pilot study (PLIMeC-P), 15 eligi... |
For the main PLIMeC study we will use a mixed method approach, combining various data collection and analysis methods (qualitative and quantitative). Quantitative methods will be used to obtain a breadth of understanding of the phenomenon of interest, and qualitative methods will be used to explore and obtain depth of ... |
<|newrecord|> nctId: NCT06377176 id: NTUNHSEN briefTitle: Postpartum Massage Therapy for Women and Infants: The Effect on Maternal Depression, Stress, Fatigue and Infant Temperament overallStatus: COMPLETED date: 2021-06-16 date: 2021-10-03 date: 2021-10-03 date: 2024-04-22 date: 2024-04-22 name: National Taipei Univer... |
<|newrecord|> nctId: NCT06377163 id: acquired pneumonia in children briefTitle: Bacterial Pathogens Associated With Community-acquired Pneumonia in Children overallStatus: COMPLETED date: 2021-01-01 date: 2021-08-31 date: 2021-08-31 date: 2024-04-22 date: 2024-04-22 name: Delta University for Science and Technology cla... |
This study examined common pathogens of community-acquired pneumonia from 28 days up to 10 years in Dakahlia Governorate. conditions: Children Pneumonia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ACTUAL measure: Complete blood count measure: C-reactive protein (C... |
<|newrecord|> nctId: NCT06377150 id: ABCA4-1382022BO2 briefTitle: Stargardt Disease in Childhood overallStatus: COMPLETED date: 2022-04-01 date: 2024-03-31 date: 2024-03-31 date: 2024-04-22 date: 2024-04-22 name: University Hospital Tuebingen class: OTHER briefSummary: Retrospective chart review study to elucidate the ... |
<|newrecord|> nctId: NCT06377137 id: University of the Porto briefTitle: High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction overallStatus: COMPLETED date: 2023-03-10 date: 2023-04-10 date: 2023-09-01 date: 2024-04-22 date: 2024-04-22 name: Universidade do Porto ... |
The objective of this research is to determine the effects of a 16-week high-intensity SSSG-based exercise intervention on cardiometabolic risk factors, physical fitness, adherence to 24-hour movement patterns, enjoyment and adherence to the intervention in adolescents with metabolic dysfunction and compare them to the... |
The investigators hypothesize that high-intensity SSSG are more effective in improving the obesity-related cardiometabolic risk profile in adolescents with cardiometabolic dysfunction compared to traditional soccer training. |
A parallel 3-arm randomized controlled trial will be conducted in adolescents with overweight and metabolic dysfunction between 11 and 15 years of age. The inclusion criteria are: (i) age between 11-15 years at the time of intervention start; (ii) overweight or obesity (BMI\> 85th percentile); (iii) Abdominal obesity ≥... |
Those eligible to participate in the study will be randomly assigned to one of three groups: i) SSSG group, ii) traditional soccer play group (TSG), or, iii) non-exercise intervention control group (CG). Participants in both exercise intervention groups will undergo a 16-week intervention. The SSSG group will participa... |
The study protocol was approved by the Ethics Committee of the Faculty of Sport of the University of Porto and by the Scientific Ethics Committee of the Adventist University of Chile. conditions: Obesity, Adolescent conditions: Metabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionM... |
<|newrecord|> nctId: NCT06377124 id: UW21-507 briefTitle: A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-03-31 date: 2026-06-30 date: 2024-04-22 date: 2024-04-22 name: The University of Hong Kong class: OTHE... |
The general health information includes an individual session, messaging and phone contact related to general health information, and hotline services. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The outcome assessor was not aware of which groups the patients belonged to. whoMasked: OUTCOMES_ASS... |
<|newrecord|> nctId: NCT06377111 id: PANTHEON-IO briefTitle: A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: University Health Network, Toronto class: OTHER briefSummary: This study is... |
<|newrecord|> nctId: NCT06377098 id: UAB-300010901 id: UAB Dixon Endowed Ch/3102800 type: OTHER_GRANT domain: UAB Dixon Endowed Chair briefTitle: Intrapartum Sildenafil in Laboring Mothers acronym: PRISM overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2028-01-31 date: 2024-04-22 date: 2024-04-... |
The main questions it aims to answer are: |
* What are the fetal heart rate monitoring practices in a low-resource setting? |
* What are the indications for operative delivery in a low-resource? |
* What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil? |
* What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting? |
Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected. |
Participants will: |
* Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor |
* Have the (mothers \& babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag \& mask ventilation, Apgar scores, and seizures. |
* Have a neonatal neurological assessment prior to discharge |
* Have phone call assessments for re-hospitalization or mortality 7 days post-delivery |
* Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call |
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