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Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022

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ClinicalTrials.gov Identifier: NCT06055192
Recruitment Status : Not yet recruiting
First Posted : September 26, 2023
Last Update Posted : September 26, 2023
Sponsor:
Collaborator:
Opera CRO, a TIGERMED Group Company
Information provided by (Responsible Party):
Effik SA

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment
Nausea Vomiting of Pregnancy Other: Survey

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Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Other
Official Title: Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Survey
    Survey

Outcome Measures
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Primary Outcome Measures :
  1. Primary Outcome Measure [ Time Frame: 185 days ]
    Evaluate the prevalence and burden that the symptoms of nausea and vomiting have in pregnant women in Switzerland


Secondary Outcome Measures :
  1. Secondary Outcome Measure [ Time Frame: 185 days ]
    demographic data (including ethnicity: Caucasian, African, Asian or Other).

  2. Secondary Outcome Measure [ Time Frame: 185 days ]
    NVP prevalence

  3. Secondary Outcome Measure [ Time Frame: 185 days ]
    Percentage of mild, medium, and severe cases based on PUQE-24.

  4. Secondary Outcome Measure [ Time Frame: 185 days ]
    Percentage of answer allocation to NVP related questions

  5. Secondary Outcome Measure [ Time Frame: 185 days ]
    Onset for each symptom and its duration

  6. Secondary Outcome Measure [ Time Frame: 185 days ]
    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.

  7. Secondary Outcome Measure [ Time Frame: 185 days ]
    Correlation of the above-mentioned parameters with the use of non-pharmacological, pharmacological (e.g., Cariban®) or both therapies.

  8. Secondary Outcome Measure [ Time Frame: 185 days ]
    Analysis of drug therapies, their correlation with the severity of the symptoms during pregnancy and with the possible outcomes of the same

  9. Secondary Outcome Measure [ Time Frame: 185 days ]
    Correlation between the severity of the symptoms and the consequences on the woman's personal life (family, work, etc.).

  10. Secondary Outcome Measure [ Time Frame: 185 days ]
    Number of cases with hospitalization in relation to total and severity of symptoms (PUQE-24).

  11. Secondary Outcome Measure [ Time Frame: 185 days ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   200 women during the weeks 18-22 of their pregnancy
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
200 women during the weeks 18-22 of their pregnancy
Criteria

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).
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
SR 810.301 - Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO) [Internet]. [cited 2022 Jun 13]. Available from: https://www.fedlex.admin.ch/eli/cc/2013/642/en
fedlex-data-admin-ch-eli-cc-2013-643-20140101-en-pdf-a.pdf [Internet]. [cited 2022 Jun 13]. Available from: https://fedlex.data.admin.ch/filestore/fedlex.data.admin.ch/eli/cc/2013/643/20140101/en/pdf-a/fedlex-data-admin-ch-eli-cc-2013-643-20140101-en-pdf-a.pdf
WMA - The World Medical Association-WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects [Internet]. [cited 2022 Jun 13]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
de Tejada BM, Vonzun L, Mandach DUV, Burch A, Yaron M, Hodel M, et al. Nausea and Vomiting of Pregnancy, Hyperemesis gravidarum. :5.
Brott NR, Reddivari AKR. Doxylamine. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 [cited 2023 Jun 22]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK551646/
APGO. APGO. Nausea and vomiting of pregnancy. APGO Educational series on women's health issues. Boston: Jespersen & Associates, LLC; 2013. 2013.
Nausea and Vomiting of Pregnancy (NVP). 2022;
Office FS. Births [Internet]. [cited 2022 Jun 14]. Available from: https://www.bfs.admin.ch/bfs/en/home/statistiken/bevoelkerung/geburten-todesfaelle/geburten.html

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Responsible Party: Effik SA
ClinicalTrials.gov Identifier: NCT06055192    
Other Study ID Numbers: OPEFF/0122/SU
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Effik SA:
Nausea
Vomiting
Pregnancy
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive