CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Report for D011248: Pregnancy Complications NIH

(Synonyms: Pregnancy Compli, Pregnancy Complications)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (7)

Name (Synonyms) Correlation
drug2354 RT-PCR and antibody testing Wiki 0.41
drug191 An auto-questionnaire comprising three psychometric scales Wiki 0.41
drug3201 biological samples, questionnaires and interviews Wiki 0.41
drug2907 This is an online survey with no intervention. Wiki 0.41
drug3480 standardized Lung Ultrasound (LUS) examination Wiki 0.41
drug2350 RT PCR SARS-CoV-2 Wiki 0.41
drug1284 Hydroxychloroquine Wiki 0.04

Correlated MeSH Terms (8)

Name (Synonyms) Correlation
D011251 Pregnancy Complications, Infectious NIH 0.41
D011254 Pregnancy in Diabetics NIH 0.41
D011024 Pneumonia, Viral NIH 0.05
D003141 Communicable Diseases NIH 0.03
D011014 Pneumonia NIH 0.02
D007239 Infection NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.02

There are 6 clinical trials

Clinical Trials

1 A Prospective International Lung UltraSound Analysis (ILUSA) Study in Tertiary Maternity Wards During the SARS-CoV-2 Pandemic

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.

NCT04353141 COVID Pregnancy Complications, Infectious Pregnancy Related Pregnancy, High Risk Pregnancy Disease Pneumonia Pneumonia, Viral Diagnoses Disease Diagnostic Test: standardized Lung Ultrasound (LUS) examination
MeSH:Pregnancy Complications, Infectious Pneumonia, Viral Pneumonia Pregnancy Complications

Primary Outcomes

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

2 Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic

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.

NCT04385238 COVID-19 Pregnancy Complications Mental Health Wellness 1 Anxiety Depression Ptsd Coronavirus Other: This is an online survey with no intervention.
MeSH:Pregnancy Complications

Primary Outcomes

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.

3 COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study

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.

NCT04416373 Coronavirus Infection Pregnancy Complications Vertical Transmission of Infectious Disease Breastfeeding Neonatal Infection Diagnostic Test: RT PCR SARS-CoV-2
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pregnancy Complications

Primary Outcomes

Description: Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples

Measure: SARS-CoV-2 Neonatal Infection

Time: 7 days

Secondary Outcomes

Description: stillbirths and deaths in the first week of life

Measure: Perinatal mortality

Time: 35 weeks

Description: maternal ICU admission due to COVID-19

Measure: ICU maternal admission

Time: 35 weeks

Description: Newborn 5 minute Apgar Score < 7

Measure: 5 minute Apgar Score < 7

Time: 1 day

Description: Delivery between 24 and 36 weeks

Measure: Preterm labour

Time: 35 weeks

Description: Preterm premature rupture of the membranes between 24 and 36 weeks

Measure: PPROM

Time: 35 weeks

Description: spontaneous pregnancy loss before 24 weeks

Measure: Miscarriage

Time: 14 weeks

4 COVID-19 and Obstetric Transmission

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.

NCT04418557 COVID Pregnancy Complications Diagnostic Test: RT-PCR and antibody testing
MeSH:Pregnancy Complications

Primary Outcomes

Description: Viral presence in any of the collected specimens

Measure: Presence of COVID-19 virus

Time: At time of delivery

Secondary Outcomes

Description: Antibodies detected in any of the collected specimens

Measure: Presence of antibodies to COVID-19 virus

Time: At time of delivery and 24 hours of life of the newborn

Other Outcomes

Description: Innate/Adaptive cell function and immune response

Measure: 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

5 COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study

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.

NCT04433364 Sars-CoV2 Covid-19 Pregnancy Complications Pregnancy Preterm Pregnancy in Diabetic Neonatal Infection Other: biological samples, questionnaires and interviews
MeSH:Pregnancy Complications Pregnancy in Diabetics

Primary Outcomes

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

6 Covid-19 in Pregnancy: a French Population-based Cohort of Women and Newborns

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

NCT04463758 covid19 In covid19 Infection Pregnancy Complications Neonatal Complications Other: An auto-questionnaire comprising three psychometric scales
MeSH:Pregnancy Complications

Primary Outcomes

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, transfusion

Measure: Joint evaluation of morbi-mortality for mother and child up to 12 weeks postpartum

Time: At12 weeks after delivery

Secondary Outcomes

Measure: Number of women infection COVID-19

Time: During pregnancy and up to 12 weeks

Measure: Severe forms of COVID-19 infection in the mother

Time: Until 12 weeks after delivery

Measure: Severe neonatal morbidity

Time: Until 12 weeks after delivery

HPO Nodes