Prevalence And Burden Of Nausea And Vomiting In Pregnant Women
NCT ID: NCT04926727
Last Updated: 2021-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2021-10-04
2022-05-31
Brief Summary
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Numerous epidemiological researches conducted in the US and Norway have highlighted the extent of vomiting and pregnant nausea. Unfortunately to date, there are no information on the prevalence of this phenomenon in Italy, on its impact on women's lives and on the interaction between woman and gynecologists.
The research hypothesis of the present survey is that, using a representative sample of pregnant women in Italy, it will be possible to identify the prevalence and weight of nausea and vomiting symptoms during pregnancy in this country. The study is an open, non-comparative, multicenter survey and the aim is to evaluate the prevalence and weight that the symptoms of nausea and vomiting have in pregnant women in Italy.
The study population will include 600 women found during weeks 18-22 of pregnancy who will arrive at the three sites or will contact the Investigators after the Ethics Committee (EC) approval.
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Pregnant women
600 Pregnant women between the 18th and 22nd week.
* 200 from Northern Italy;
* 200 from Central Italy;
* 200 from Southern Italy and the Islands.
Survey
Observational study
Interventions
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Survey
Observational study
Eligibility Criteria
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Inclusion Criteria
* Women able to communicate adequately with the interviewer and understand the questionnaires.
* Women able to understand and who can provide valid informed consent to the Survey.
Exclusion Criteria
* Medically assisted procreation (MAP)
18 Years
FEMALE
Yes
Sponsors
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Opera CRO, a TIGERMED Group Company
OTHER
Italfarmaco
INDUSTRY
Responsible Party
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Locations
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Policlinico di Napoli - Università di Napoli "Federico II"
Napoli, Corso Umberto I 40, Italy
P.O. SS.ma Annunziata di Chieti della ASL di Chieti
Chieti, Via Dei Vestini, Italy
Ospedale dei Bambini "Vittore Buzzi"
Milan, Via Lodovico Castelvetro, 32, Italy
Countries
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Central Contacts
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Other Identifiers
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OPITA/0120/SU
Identifier Type: -
Identifier Source: org_study_id
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