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There are 3 clinical trials
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.
Description: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.Measure: Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. Time: within 6 weeks (42 days)
Description: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo groupMeasure: Neonatal: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group Time: 4 weeks (28 days) post-delivery
Description: Fever (>100.4°F/38°C) in addition to one or more of the following: fetal tachycardia ≥160 bpm, maternal tachycardia >100 bpm, tender uterus between contractions, or purulent/foul smelling discharge from uterus prior to delivery.Measure: Incidence of chorioamnionitis Time: prior to delivery
Description: Fever (>100.4°F/38°C) in addition to one or more of maternal tachycardia >100 bpm, tender uterine fundus, or purulent/foul smelling discharge from uterus after delivery.Measure: Incidence of endometritis Time: within 42 days post-delivery
Description: Wound infection (Purulent infection of a perineal or Cesarean wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); Abdominopelvic abscess (Evidence of pus in the abdomen or pelvis noted during open surgery, interventional aspiration or imaging); Pneumonia (Fever >100.4°F/38°C and clinical symptoms suggestive of lung infection including cough and/or tachypnea >24 breaths/min or radiological confirmation); Pyelonephritis (Fever >100.4°F/38°C and one or more of the following: urinalysis/dip suggestive of infection, costovertebral angle tenderness, or confirmatory urine culture); Mastitis/breast abscess or infection (Fever >100.4°F/38°C and one or more of the following: breast pain, swelling, warmth, redness, or purulent drainage).Measure: Incidence of other infections Time: within 42 days post-delivery
Description: Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason.Measure: Incidence of use of subsequent maternal antibiotic therapy Time: after randomization to 42 days post-delivery
Description: Time from drug administration until initial discharge after delivery (time may vary by site).Measure: Maternal initial hospital length of stay Time: within 42 days post-delivery
Description: Maternal readmissions within 42 days of deliveryMeasure: Incidence of maternal readmissions Time: within 42 days post-delivery
Description: Maternal admission to special care unitsMeasure: Incidence of maternal admission to special care units Time: within 42 days post-delivery
Description: Maternal unscheduled visit for careMeasure: Incidence of maternal unscheduled visit for care Time: within 42 days post-delivery
Description: Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects.Measure: Incidence of maternal GI symptoms Time: within 42 days post-delivery
Description: Maternal death due to sepsis using the Global Network algorithm for cause of deathMeasure: Incidence of maternal death due to sepsis Time: within 42 days post-delivery
Description: Incidence of other neonatal infections.Measure: Incidence of other neonatal infections (e.g. eye infection, skin infection) Time: within 42 days post-delivery
Description: Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site).Measure: Neonatal initial hospital length of stay Time: within 28 days of delivery
Description: Neonatal readmissions within 42 days of deliveryMeasure: Incidence of neonatal readmissions Time: within 42 days of delivery
Description: Neonatal admission to special care unitsMeasure: Incidence of neonatal admission to special care units Time: within 28 days of delivery
Description: Neonatal unscheduled visit for careMeasure: Incidence of neonatal unscheduled visit for care Time: within 42 days post-delivery
Description: Neonatal death due to sepsis using the Global Network algorithm for causes of deathMeasure: Incidence of neonatal death due to sepsis Time: within 28 days of delivery
Description: Pyloric stenosis within 42 days of delivery, defined as clinical suspicion based on severe vomiting leading to death, surgical intervention (pyloromyotomy) as verified from medical records, or radiological confirmation.Measure: Incidence of pyloric stenosis within 42 days of delivery Time: within 42 days of delivery
Currently there is a great need for an accurately and rapid assessment of patients suspected for Covid-19. Like CT, Lung Ultrasound (LUS) examination can potentially help with the initial triage of patients but also help track the evolution of the disease. LUS can be used in every setting, including settings with limited infrastructure, allowing the reduction of disparities in trials participation. LUS is also a practical approach that can be used by obstetricians/gynecologists, who are the primary care givers in the labour and delivery room. The International Lung UltraSound Analysis (ILUSA) Study is an international multicenter prospective explorative observational study to assess the predictive value of LUS in Covid-19 suspected and diagnosed pregnant patients.
Description: The primary endpoint is diagnostic performance in terms of the area under the receiver operating characteristic curve (AUC, also known as the c-statistic) and sensitivity and specificity with regard to the prediction of poor outcome. Outcome at one week from admission: good outcome includes discharge or inpatient breathing in free air; poor outcome includes patient with oxygen support, patients with CPAP/ high oxygen flow cannula, or patient with endotracheal intubation during the week.Measure: Diagnostic performance of LUS to predict poor outcome Time: outcome one week after enrollment into the study
Complete blood count parameters are routinely evaluated cost-effective markers in diagnosis and clinical follow-up of infectious diseases.There is increasing number of studies to report the course of COVID-19 in pregnancy. The current study aimed to elucidate the changes in hematologic parameters in response to SARS-CoV-2 infection and whether there was an increase in adverse perinatal outcomes such as increased neonatal intensive care unit admission and lower APGAR scores in pregnancies with COVID-19.
Description: cell count per mm3.Measure: complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells). Time: first 1 hour of hospitalization.
Description: 1st and 5th minute newborn assessmentMeasure: APGAR score Time: 5 minutes
Description: centimetersMeasure: maternal and newborn length Time: 5 minutes
Description: kilogramsMeasure: maternal and newborn weight Time: 2 minutes
Description: Celsius degreeMeasure: body temperature Time: 2 minutes
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports