|drug4126||standardized Lung Ultrasound (LUS) examination Wiki||0.33|
|drug228||An auto-questionnaire comprising three psychometric scales Wiki||0.33|
|drug1241||Exercise program Wiki||0.33|
|drug1457||Healthy lifestyle advise Wiki||0.33|
|drug3693||WHO recommendations (waiting condition) Wiki||0.33|
|drug3462||This is an online survey with no intervention. Wiki||0.33|
|drug3807||biological samples, questionnaires and interviews Wiki||0.33|
|drug2785||RT PCR SARS-CoV-2 Wiki||0.33|
|drug2||"Vernonia amygdalina" Wiki||0.33|
|drug2789||RT-PCR and antibody testing Wiki||0.33|
|drug1428||Guided online support program Wiki||0.33|
|D005317||Fetal Growth Retardation NIH||0.33|
|D005322||Fetal Membranes, Premature Rupture NIH||0.33|
|D011254||Pregnancy in Diabetics NIH||0.33|
|D046110||Hypertension, Pregnancy-Induced NIH||0.33|
|D000037||Abruptio Placentae NIH||0.33|
|D000078064||Gestational Weight Gain NIH||0.33|
|D015430||Weight Gain NIH||0.33|
|D011251||Pregnancy Complications, Infectious NIH||0.19|
|D011024||Pneumonia, Viral NIH||0.04|
|D003141||Communicable Diseases NIH||0.03|
|D045169||Severe Acute Respiratory Syndrome NIH||0.01|
|D018352||Coronavirus Infections NIH||0.01|
There are 9 clinical trials
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
The purpose of this study is to assess the health and wellbeing of pregnant and recently pregnant women during the COVID-19 pandemic using an online survey.
Description: Post-traumatic Stress Disorder (PTSD) Symptoms will be assessed by the Impact of Events Scale-6. This scale includes a total of six items: two items from each of the three subscales of the measure, namely intrusion, hyperarousal and avoidance. Participants will be asked to report their PTSD symptoms in the past 7 days on a Likert Scale ranging from 0 (not at all) to 4 (extremely).Measure: Post-traumatic Stress Disorder Time: Anytime during pregnancy or within 6 months after given birth.
Description: Symptoms of anxiety and depression will be measured by the Patient Health Questionnaire-4 (PHQ-4) which combines two ultrabrief screeners: the PHQ-2 and the Generalised Anxiety Disorder Scale. Participants will be asked to report their symptoms of depression and anxiety in the past 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day) for a maximum score of 12.Measure: Anxiety and Depression Time: Anytime during pregnancy or within 6 months after given birth.
This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.
Description: Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samplesMeasure: SARS-CoV-2 Neonatal Infection Time: 7 days
Description: stillbirths and deaths in the first week of lifeMeasure: Perinatal mortality Time: 35 weeks
Description: maternal ICU admission due to COVID-19Measure: ICU maternal admission Time: 35 weeks
Description: Newborn 5 minute Apgar Score < 7Measure: 5 minute Apgar Score < 7 Time: 1 day
Description: Delivery between 24 and 36 weeksMeasure: Preterm labour Time: 35 weeks
Description: Preterm premature rupture of the membranes between 24 and 36 weeksMeasure: PPROM Time: 35 weeks
Description: spontaneous pregnancy loss before 24 weeksMeasure: Miscarriage Time: 14 weeks
The aim of this study is to capture data, laboratory markers, and clinical outcomes of obstetric and neonatal outcomes in cases of COVID-19 during pregnancy in Cuyahoga County.
Description: Viral presence in any of the collected specimensMeasure: Presence of COVID-19 virus Time: At time of delivery
Description: Antibodies detected in any of the collected specimensMeasure: Presence of antibodies to COVID-19 virus Time: At time of delivery and 24 hours of life of the newborn
Description: Innate/Adaptive cell function and immune responseMeasure: Immune responses to COVID-19 virus What is the Immune responses of a mother infected with COVID-19 and neonates? What is the Immune responses of a mother infected with COVID-19 and neonates? Immune response to COVID-19 virus Time: At time of delivery and 24 hours of life of the newborn
Purpose: The emergence of a new coronavirus, coronavirus 2 (SARS-CoV-2) causing a novel infection in the human race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both for individual human lives as well as for the society and for the health care sector. The knowledge on how this new infection affects both the mother and the unborn child as well as the outcomes for the mother and the child in the long run are unknown. What is known is based on case-reports and small case-series solely. Both the coronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring, which leads to the question whether this could be the case also for SARS-CoV-2. Aims: To establish a biobank of biological material from infected as well as non-infected pregnant women and their offspring. To combine this biobank with Swedish quality and health care registers, computerized patient charts and questionnaire data, enabling both short-term follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and child. To study how the pandemic situation affects both the mother and her partner in their experience of pregnancy, childbirth, and early parenthood. Design: A national Swedish multicentre study. Women are included when they have a positive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included at their routine visits (Screening group). Blood samples and other biological material will be collected at different time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy Register as well as obligatory Swedish health registers. The biobank and its linkage to health registers through the Swedish personal identification number will enable future research. Child development will be followed during the first year of life by questionnaires to the parents. Womens' and their partners' experience of childbirth and parenthood will be studied in form of questionnaires based on validated instruments as well as in form of interviews. Sweden is one of few countries with prerequisites enabling a nearly population-based follow-up, even under the pandemic condition with considerable strains for the health care system. Conclusion: This project will help obstetricians and neonatologists in better recognizing the clinical manifestations of the virus, identify possible risk factors during pregnancy and tailor therapies along with providing the right level of surveillance and management during pregnancy, delivery, and child health care. The project will also enable sharing important unusual outcome data with other research collaborators, e.g. outcome for pregnant women with diabetes.
Description: establish a biobank and database with bio-samples from both women that are not tested and presumed healthy as well as possibly ill and women confirmed tested positive for SARS-CoV-2 and their infants linked to Swedish health care registers including socio-economic factors and use serological and viral analyses from the biological samples to evaluate maternal, fetal and neonatal outcomes.Measure: Biobank with linkage to registers Time: 1-20 years
Description: study how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19-pandemic, both for women not tested and for women tested positive for SARS-CoV-2.Measure: Experiences of pregnancy during a pandemic Time: 1 year
The purpose of this study is to characterize the incidence and clinical features of the maternal COVID 19 infection, as well as the associated morbidity of the mother and the child, in the French context
Description: Maternal Criterion: Validated Composite Criterion of Severe Maternal Morbidity (Epimoms study ref 7). Neonatal Criterion: Mortality and Composite Criterion of Severe Neonatal Morbidity Perinatal asphyxia (arterial pH to cord-7.15 and/or an excess base - 10mmol/L and/or lactates-6 mmol/L, Apgar score at 5 minutes -7), neonatal encephalopathy, seizures, intraventricular hemorrhage, cerebral infarction, periventricular leucomalacia, ulcerative enterocolite, sepsis, respiratory distress syndrome, bronchopulmonary dysplasia, central catheter, ventilatory support, transfusionMeasure: Joint evaluation of morbi-mortality for mother and child up to 12 weeks postpartum Time: At12 weeks after delivery
A cohort study of women who deliver at select sites on randomly selected days in 2019 and 2020, and all confirmed COVID-19 infections among pregnant or immediately postpartum women in 2020. The study population includes approximately 24,400 deliveries on randomly selected days in 2019 and 2020, and an additional 1000-2100 confirmed COVID-19 infections among pregnant women or immediately postpartum.
Description: Percentage of patients with at least one of the following: mortality, morbidity related to hypertensive disorders of pregnancy, morbidity related to postpartum hemorrhage, morbidity related to infectionMeasure: Maternal Mortality and Morbidity Composite Time: During pregnancy through 6 weeks postpartum
Description: Percentage of patients that had cesarean deliveryMeasure: Cesarean Delivery Time: Delivery
Description: Percentage of patients with at least one of teh following: death, ICU admission, transfusion of 4 or more units of packed red blood cellsMeasure: Severe maternal morbidity or mortality Time: During pregnancy through 6 weeks postpartum
Description: a. Percentage of patients with the following outcomes: ICU admission, ventilator support, extracorporeal membrane oxygenation (ECMO), pressor support, cardiomyopathy, venous thromboembolism (deep venous thrombosis or pulmonary embolus), arterial thrombosis including cerebrovascular accident, cerebral venous sinus thrombosis, renal failure requiring dialysis, encephalopathy, superficial or deep incisional surgical site infection, multisystem inflammatory syndromeMeasure: Adverse maternal outcomes Time: During pregnancy through 6 weeks postpartum
Description: a. Percentage of neonates with the following outcomes: fetal or neonatal death, preterm birth < 37 weeks gestation, small for gestational age, major congenital malformations, perinatal preterm composite (defined as fetal or neonatal death, severe bronchopulmonary dysplasia, intraventricular hemorrhage grades III-IV, necrotizing enterocolitis, periventricular leukomalacia, retinopathy of prematurity stage III-V, or proven sepsis), perinatal term composite (defined as fetal or neonatal death, respiratory support within first 72 hours, Apgar score <=3 at 5 minutes, hypoxic ischemic encephalopathy, seizure, infection, birth trauma, meconium aspiration syndrome, intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor supportMeasure: Adverse neonatal outcomes Time: Delivery through hospital discharge up to 120 days
Description: Percentage of neonates with infection diagnosed within delivery hospitalizationMeasure: Neonatal infection Time: Delivery through hospital discharge up to 120 days
Description: Number of maternal in-patient hospitalization daysMeasure: Maternal in-patient hospitalization days Time: During pregnancy through 6 weeks postpartum
Description: Percentage of patients admitted to the ICUMeasure: Maternal ICU admission Time: During pregnancy through 6 weeks postpartum
Description: Length of time on labor and delivery from admission to delivery for the delivery hospitalizationMeasure: Duration of labor and delivery Time: During pregnancy through delivery
Description: Length of time from delivery to hospital dischargeMeasure: Neonatal length of stay Time: Delivery through hospital discharge up to 120 days
Description: Length of time from neonatal ICU admission to hospital dischargeMeasure: Neonatal ICU length of stay Time: Delivery through hospital discharge up to 120 days
Study title Spanish Registry of Pregnant Women with COVID-19 Protocol number and version Number 55/20. Version V8. Sponsors This registry is a project promoted by Dr. Oscar Martínez Pérez of the Obstetrics and Gynaecology department of the Puerta de Hierro University Hospital. Principal investigator of the registry National coordinator: Dr. Óscar Martínez Pérez. Obstetrics and Gynaecology Department. Puerta de Hierro University Hospital. Majadahonda. Epidemiologist: Maria Luisa de la Cruz Conti Researchers for each site: 100 sites from 32 Spanish provinces are included (Appendix 1) Funding Neither the hospitals nor the participating investigators will receive any financial compensation for their collaboration. A bank account has been opened at the hospital's Biomedical Research Foundation to receive donations: COV20/00021 - SARS-COV-2 and the COVID-19 disease Call financed by the Carlos III Institute of Health and co-financed with ERDF funds. Abstract Rationale: Knowledge about the impact of the SARS-CoV-2 virus on pregnancy is still scarce and all current recommendations are based on less than 100 cases published in the literature. To identify moderate effects (such as vertical transmission, obstetric morbidity, foetal death, maternal or neonatal death) and to allow accurate risk estimates, larger sample sizes than those currently available are required. Methods: Prospective observational study of pregnant women in whom SARS-CoV-2 infection is suspected at any time during pregnancy with positive test results for SARS-CoV-2, in order to create a registry of baseline characteristics of the pregnant woman, aspects related to the course of pregnancy and delivery, and related to the new-born, with an observation period of up to 14 days after delivery. Subsequently, several phased studies will be conducted to help establish and monitor the set of measures to improve the care of pregnant women. Discussion: The national registry for COVID-19 in pregnancy described here is a tool for sharing and centralizing data related to exposures to SARS-CoV-2 during pregnancy in a structured way. It should speed up the process of prospectively obtaining a large unbiased data set and will collect information at national level.
Description: MATERNAL MORTALITY MORBIDITYMeasure: MATERNAL COMPLICATIONS Time: 1 year
Description: VERTICAL TRANSMISIONMeasure: NEONATAL INFECTION Time: 1 year
Historically and traditionally, the recommendations related to physical exercise during pregnancy have been based more on moral or cultural issues than on scientific evidence. During some phases of history, pregnancy has meant a period of seclusion for women (not only physical). One of the adverse consequences has been the common recommendation of rest as a general rule for pregnant women. Scientific evidence from recent years has achieved a better understanding of the process of pregnancy and childbirth as well as maternal and fetal responses to exercise. Currently, both from a scientific and clinical/obstetric point of view, there is no doubt about the benefits of an active pregnancy for entire body of pregnant woman, and even her child. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation, even more with important associated complications during pregnancy and postpartum period. Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in this sense the necessary measures taken by the different administrations, especially in terms of confinement causes (from now on) a large number of complications affecting different populations. In summary a complex situation without established prevention strategies exists. The pregnant population is, due to the nature of the gestation and delivery process, one of the population groups with the highest risk of adverse outcomes and associated complications and whose consequences include the mother, fetus, newborn and even children. According to an important body of scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining factor for the future human being to evolve regardless of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and observable postnatal pathologies in infants. In addition, current publications report the large number and variety of alterations that the COVID-19 situation causes in pregnant women and that includes the entire female organism. This complex situation does not only affect aspects of a physical or physiological nature, but also psychic and emotional factors. In summary, a new state of confinement or similar situations in the near future (impossibility of groupings, distance between people), avoid during the daily life of pregnant women one of the important and recent recommendations made by the international scientific community: a pregnancy physically active. This is especially relevant, due to the dangerous association between complications of a psychological or emotional nature during pregnancy with pre, peri and postnatal disorders (low birth weights, perinatal complications, altered and prolonged deliveries, etc.), which affect not only to the mother and can determine the health of the future human being. According to the scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining aspect in the health of the future human being and the prevention of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous and recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and different pathologies during and after pregnancy. It is evident the change that COVID-19 and its effects will generate in the lifestyle of the pregnant population and the increased probability of suffering associated pathologies in the next 24-36 months. No preventive actions have yet been planned in Spain and its public hospitals against the impact of COVID-19 on the quality of life of pregnant women. It is urgent to design and perform an adequate strategy of intervention for its possible prevention. From the scientific point of view, the recommendations are clear and concrete, an aerobic exercise program, designed and supervised by professionals from the Sciences of Physical Activity and Sports, is the best option for pregnant women. In this sense, in the last 30 years, physical exercise has proven to have many benefits for pregnant women, without causing risks or adverse effects on maternal-fetal well-being. This is confirmed by an important body of scientific literature on gestational physical exercise and its effects on pregnancy outcomes.
Description: analyze the increase during pregnancyMeasure: Maternal weight gain Time: 9 months
Description: analyze how it varies during pregnancyMeasure: blood pressure Time: 9 months
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: OGTT-O'Sullivan test Time: 1 month
Description: analyze with a questionnaire the value and its interrelationship with physical exercise patternsMeasure: Urinary Incontinence Questionnaire (ICIQ-SF) Time: 9 months
Description: analyze with a questionnaire the variability during pregnancyMeasure: depression scale (CES-D) Time: 9 months
Description: analyze variability during pregnancyMeasure: Behavior of Fetal Heart Rate Time: 3 months
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: gestational age Time: 9 months
Description: analyze whether women have had a vaginal, instrumental or cesarean delivery and its interrelationship with physical exercise patternsMeasure: type of delivery (Vaginal, instrumental or cesarean) Time: 1 month
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: duration of labor Time: 1 month
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: birthweight Time: 1 month
Description: analyze the value and its interrelationship with physical exercise patterns during pregnancyMeasure: child's weight Time: 24 months
Description: analyze the value and its interrelationship with physical exercise patterns during pregnancyMeasure: child's height Time: 24 months
Description: analyze the value and its interrelationship with physical exercise patterns during pregnancyMeasure: mental assessment of the child (depression questionnaire adapted to childhood) Time: 24 months
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: Maternal pains during pregnancy (headache, back pain, pelvic pain, paravertebral, scapular, etc.) Time: 9 months
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: fetal growth and development Time: 9 months
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: Delivery tears Time: 1 month
Description: analyze the appearance (descriptive: yes/no) and its interrelationship with physical exercise patternsMeasure: performing episiotomy during childbirth Time: 1 month
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: Apgar Score Time: 1 month
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: length Time: 1 month
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: cranial perimeter Time: 1 month
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: Landau reflexes test Time: 1 month
Description: analyze the number of admissions and its interrelationship with physical exercise patternsMeasure: neonatal intensive care unit (NICU) Time: 1 month
Description: analyze how it varies during postpartum periodMeasure: Postpartum recovery of pre-pregnancy weight Time: 12 months
Description: analyze with a questionnaire how it varies during postpartum periodMeasure: Edinburgh Postpartum Depression Scale (EPDS) Time: 12 months
Description: analyze the value and its interrelationship with physical exercise patternsMeasure: Perception of health status - SF36 health scale Time: 24 months
Description: analyze the diameter and thickness of muscles in the perineal area and its interrelationship with physical exercise patternsMeasure: Recovery of pelvic floor muscles ultrasound Time: 6 months
Description: analyzewith a questionnaire how it varies during and after pregnancyMeasure: Maternal habits of physical activity - Pregnancy Physical Activity Questionnaire (PPAQ) Time: 12 months
Data processed on September 26, 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