Nausea Clinical Trial
Official title:
Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022
Verified date | September 2023 |
Source | Effik SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The latest data on the prevalence of nausea in pregnancy in Switzerland is dated 2015 but has been hypothesised that the recent introduction on the market of new drugs against this symptom could modify its epidemiology. For this reason, we have planned the present survey, calculating an adequate sample size of Swiss pregnant women (the population of interest) and, according to a cross-sectional design, planning the collection of response variables with the aim of estimating the prevalence of burden and nausea and vomiting in pregnancy
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | October 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Subjects will be eligible for inclusion if all the following criteria are respected: - Women aged = 18 years. - Women in physiological pregnancy and between the 18th and 22nd week of pregnancy (at time of morphological ultrasound). - Women able to communicate adequately with the Investigator and able to read, understand and provide the answers required by the questionnaires in one of the languages in which they will be provided (Italian, German, French or English). - Women able to understand and who can provide valid informed consent to the Survey. Exclusion Criteria: - Subjects fulfilling one or more of the following exclusion criteria will not be included in the study: - Twin pregnancy. - Medically assisted procreation (MAP). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Effik SA | Opera CRO, a TIGERMED Group Company |
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* Note: There are 42 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Outcome Measure | Evaluate the prevalence and burden that the symptoms of nausea and vomiting have in pregnant women in Switzerland | 185 days | |
Secondary | Secondary Outcome Measure | demographic data (including ethnicity: Caucasian, African, Asian or Other). | 185 days | |
Secondary | Secondary Outcome Measure | NVP prevalence | 185 days | |
Secondary | Secondary Outcome Measure | Percentage of mild, medium, and severe cases based on PUQE-24. | 185 days | |
Secondary | Secondary Outcome Measure | Percentage of answer allocation to NVP related questions | 185 days | |
Secondary | Secondary Outcome Measure | Onset for each symptom and its duration | 185 days | |
Secondary | Secondary Outcome Measure | Correlations between demographic data (age, first pregnancy status, multiparity, geographical origin, kinds of work and educational qualification) and the presence of symptoms and their severity. | 185 days | |
Secondary | Secondary Outcome Measure | Correlation of the above-mentioned parameters with the use of non-pharmacological, pharmacological (e.g., Cariban®) or both therapies. | 185 days | |
Secondary | Secondary Outcome Measure | Analysis of drug therapies, their correlation with the severity of the symptoms during pregnancy and with the possible outcomes of the same | 185 days | |
Secondary | Secondary Outcome Measure | Correlation between the severity of the symptoms and the consequences on the woman's personal life (family, work, etc.). | 185 days | |
Secondary | Secondary Outcome Measure | Number of cases with hospitalization in relation to total and severity of symptoms (PUQE-24). | 185 days | |
Secondary | Secondary Outcome Measure | Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire (weight of the new-born, gestational age at birth and any complications). | 185 days |
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