|drug484||Biological sampling Wiki||0.35|
|drug4060||psychological assessment Wiki||0.35|
|drug3853||covid-19 positive pregnant women Wiki||0.35|
|drug2323||Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop Wiki||0.35|
|drug316||Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery Wiki||0.35|
|drug4143||theraputic heparin Wiki||0.35|
|drug4177||zinc gluconate and ascorbic acid Wiki||0.35|
|drug3995||no intervention. observational cohort study Wiki||0.35|
|drug43||38 questions questionnaire Wiki||0.35|
|drug1360||GAD-7 (General Anxiety Disorder) scale Wiki||0.35|
|drug1136||EPDS (Edinburgh Postnatal Depression Scale) Wiki||0.35|
|drug4056||prophylactic heparin Wiki||0.35|
|drug3068||Self-administered questionnaires Wiki||0.35|
|drug2394||PHQ-9 (Patient Health Questionnaire) Depression Scale Wiki||0.35|
|D003866||Depressive Disorder NIH||0.29|
|D013315||Stress, Psychological NIH||0.07|
There are 8 clinical trials
Different studies have demonstrated that the absence of companionship during labor and childbirth may be responsible for a negative birth experience, an increased risk of postnatal depression and/or post traumatic stress disorders. These situation may also have a negative impact on mother-child interaction, on marital and family relationship and on the rate of maternal suicide in postpartum. However, these previous results cannot be extrapolated in the current context where the absence of the companionship is imposed by the confinement framework. The objective of the CONFINE study is to assess, for the first time, the birth experience of women in the context of limited social support in the immediate post-partum period due to confinement, as well as the associated over-risk of mental disorders, compared to a post-partum without social restriction.
Description: To detect suspicion of Post-Partum DepressionMeasure: Edinburg Postnatale Depression Scale questionnaire" score at two months after birth Time: through study completion, an average of 16 months
Description: To detect suspicion of Post traumatic stress syndromeMeasure: "Impact of Event Scale - Revised questionnaire" score at two months after birth Time: through study completion, an average of 16 months
The COVID-19 epidemic has a major impact on the organization of hospital structures as a whole. Regarding the functioning of the Maternities, it was decided by the three Maternities of AP-HP. Sorbonne University of the Pitié-Salpêtrière, Trousseau and Tenon sites, from March 20, 2020 to no longer authorize visits during the stay of mothers following childbirth. This prohibition has also been extended to spouses. This measure was guided by a concern to protect both the patients, their newborn and the entire staff of the aftermath. The period surrounding a birth is a period of strong emotional impact with an incidence of postpartum depression estimated at 15% in the general population (1). The separation of women from their spouses during this period could expose them to greater psychological vulnerability. In addition, when they return home, the patients will be isolated from their relatives due to the quarantine, which is an additional risk factor for postpartum depression. The teams of the three maternity units of AP-HP. Sorbonne University have organized themselves to be able to respond to situations of mental vulnerability during their stay with the intervention of maternity psychologists and psychiatrists and child psychiatrists as is done in the treatment usual charge. In addition, anticipating situations of greater vulnerability linked to the health crisis, the Maternity teams decided to set up a follow-up of patients after their return home through a telephone interview with psychologists or student psychologists in Master at D10 - D12 and 6-8 weeks postpartum in order to identify patients at increased risk of postpartum depression and to set up appropriate management if necessary for these patients. We therefore propose through this project to describe the consequences of this separation from the spouse during the postpartum stay and then with the family after returning home within the context of quarantine by assessing the incidence of post-partum depression during this sanitary crisis. A telephone interview of all the patients will be proposed on D10 - D12 and at 6-8 weeks postpartum using specific questionnaire to calculate a score of depression. This early identification will allow the establishment of an adapted psychological follow-up.
Description: assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemicMeasure: Proportion of patients with postpartum depression defined by an EPDS score >12 Time: Between week 6 and week 8
Description: assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemicMeasure: Proportion of patients with postpartum depression defined by an EPDS score >12 Time: Between day 10 and day 12
Description: as above, maternal psychological history as vulnerability factor included : history of perinatal loss, IMG, history of post partum depression.Measure: Presence of psycological maternal risk factor Time: Between day 1 and day 5
Description: Participants will be asked open-ended questions about their post-partum experience in the context of COVID-19 epidemic lockdown. The interviews will be transcribed and tagged with codes which have been extracted from the data. As more data is collected codes can be regrouped into concepts and then categories. These categories are the basis of the "theory model" that emerge from the narrative of the patients. The verbatim of the interview will be analyzed using NVIVO software which allows a grounded theory approach. Using software package as Nvivo (Hutchison, 2010) with automatic analysis of the verbatim to extract codes and concepts provides a transparent account of the data and enhance study validity. Verbatim are download in the software, that extract repeated lexical fields the categories from the mother's narrative. As this is a qualitative study, there are no expected outcomes. Outcomes will be determined by the themes that arise from the post-partum interview process.Measure: Measure Qualitative Interviews by Grounded theory Time: Week 14
Postnatal depression is an important problematic in French population with approximatively 10 -20% of women who suffer from postnatal depression. This pathology may have strong negative impact on both women and neonate's health. The women's satisfaction degree in front of childbirth is an important factor associated with postnatal depression since women unsatisfied of their childbirth and/or women with a complicated childbirth are more encline to suffer from postnatal depression. It is likely that the actual context of Covid 19 pandemia and the change in obstetrical cares organization may have a negative impact on women's satisfaction about their childbirth and so a negative impact on the risk of postnatal depression.
Description: proportion of women with an Edinburgh score higher than 12 between 4 and 6 weeks postpartumMeasure: Report postnatal depression between 4 of 6 weeks during the covid 19 pandemia Time: 4-6 weeks postpartum
Description: Existence of an association with postnatal depression and these factors: socio demographic women's characteristics, modalities of pregnancy management, satisfaction and experience about delivery, postnatal pelvic floor disorders, self rated health for the woman and the child, modalities of delivery, prenatal anxietyMeasure: Report factors associated with postnatal depression between 4 of 6 weeks during the covid 19 pandemia Time: 4-6 weeks postpartum
Description: Scale from 0 to 10 of satisfaction ; answers to the WOMBLSQ4 questionnaire about childbirth experience and satisfactionMeasure: Describe the experience and the satisfaction about delivery during the covid 19 pandemia Time: within the week after delivery
In our study; Anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck Depression and Anxiety Score after the disease regressed are planned. (Beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. High score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms 17-29 points = moderate depressive symptoms 30-63 points = severe depressive symptoms
Description: Evaluation of depression and anxiety score changes of covid-19 positive pregnants Pregnant women are questioned how this period was affected, as the pandemic period loaded with extra stress and caused depression and anxiety.Measure: Evaluation of depression and anxiety score changes of covid-19 positive pregnants Time: 4 months
The aim of this multicenter prospective study is to evaluate the association between the Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic and anaesthesiologic variables
Description: Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)Measure: Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale) Time: 40 days postpartum
Description: Association between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)Measure: Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery) Time: 10 minutes postpartum
Description: Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)Measure: Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain Time: 2 minutes prior to discharge from the Postanaesthesia care unit
Description: Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)Measure: Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain Time: 2 minutes after admission to the Postanaesthesia care unit
Postpartum depression (PPD) already affects up to 1 in 5 women and left untreated costs $150,000 per case over the lifespan. Under normal conditions, just 10% of women with PPD get evidence-based treatment, a situation that has worsened substantially during COVID-19. The purpose of this study is to a assess if self-referred, online adaptation of a 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop for PPD delivered up to 30 women at a time can lead to reductions in PPD, if the workshops are cost-effective, and to assess workshop impact on common complications of PPD (anxiety, partner relationship discord, problems with mother-infant attachment). 334 women will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control). Study measures will be collected at baseline (immediately before treatment workshop) and 12 weeks later (immediately before wait list control workshop).
Description: The gold standard measure of PPD in clinical practice/research. A change of 4 points is recognized as a clinically meaningful/significant improvement.Measure: Edinburgh Postnatal Depression Scale (EPDS) Time: Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.
Description: Healthcare resource utilization data will be collected using a questionnaire based on the Canadian Community Health Survey and the Service Use and Resources Form adapted for the postpartum period and used in previous PPD research. Costs will be calculated using provincial or other standard billing rates.Measure: Cost-effectiveness: Costs of service Time: Resources consumed over the 12-week trial period from the perspective of public healthcare payer will be measured.
Description: The EQ-5D-5L, a utility-based health-related quality of life instrument will be used. Its validity in measuring the impact of depression is established. Its Canadian scoring algorithm will be used. For each participant, a QALY will be calculated by multiplying the health utility for the matching time period (i.e., the area under the curve approach).Measure: Cost-effectiveness: Quality-Adjusted Life Year (QALY) Time: QALYs will be measured over the 12-week trial period.
Description: A 7-item self-report scale of symptoms of generalized anxiety disorder, the most common PPD comorbidity.Measure: Generalized Anxiety Disorder-7 (GAD-7) Time: 12 weeks
Description: 25-item maternal-report scale of mother-infant attachment.Measure: Postpartum Bonding Questionnaire Time: 12 weeks
Description: The SPS is a 24-item self-report measures of the degree to which an individual's social relationships provide support.Measure: Social Provisions Scale Time: 12 weeks
Description: A 37-item meausure of infant behavior and temperament.Measure: Infant Behavior Questionnaire - Revised (Very Short Form) Time: 12 weeks
Description: Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.Measure: Beck Depression Inventory-II (BDI-II) Time: 12 weeks
Postpartum depression (PPD) represent around 15% of birth in developed countries. The context of the COVID-19 epidemy represents a possible source of additional emotional distress. The objective of this study is to determine the screening prevalence and risk factors of postpartum depression, among women who deliver in fourth hospital in the North of France in the context of the COVID epidemy.
Description: Variation of prevalence of clinically-significant post-partum depressive symptomsMeasure: Variation of prevalence of clinically-significant post-partum depressive symptoms Time: up to 35 days after delivery
Women who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.
Description: To compare depression and anxiety HAD score of women who have a medical history ofpost-partum depression according to a follow-up or not during the quarantine by tele-consultation Score less than or egal to 7 = no case Score between 8 and 10 = uncertain case Score higher than or equal to 11 = confirmed caseMeasure: Evaluation of Hospital anxiety and depression scale (HAD) Time: 15 minutes
Description: To compare the result of EPDS in women who have a child of less 2 years old according to a follow-up or not by tele-consultation during the quarantineMeasure: Evaluation of Edinburgh Postpartum Depression Scale (EPDS) Time: 15 minutes
Description: Anxiety and depression of fathers will be assessed with HAD scaleMeasure: Evaluation of HAD score in fathers Time: 15 minutes
Description: EPDS will be assessed in fathers who have a child of less than 2 years oldMeasure: Evaluation of EPDS in fathers Time: 15 minutes
Description: The aim is to show that maternals anxious and depressive symptoms would be correlated to paternals positively symptomsMeasure: Study of the relationship between maternals and paternals symptoms Time: 15 minutes
Description: Look for a correlation between the difficulties in child during the quarantine describe by parents and anxiety and depression symptoms in parents The difficulties in child will be illustrated with the rate of children with difficulties describe by the parentsMeasure: Study of difficuties in child during the quarantine Time: 15 minutes
Description: Description of risk factors and protection factors setting up by the family during this quarantine periodMeasure: Risk and protection factors Time: 15 minutes
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