Prevalence And Burden Of Nausea And Vomiting In Pregnant Women

Study Overview
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Brief Summary
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On February 25th, 2019, ITALFARMACO launched Nuperal® in Italy, an association of doxylamine succinate and pyridoxine hydrochloride authorized by AIFA for the symptomatic treatment of nausea and vomiting in pregnancy (NVP). This drug is also recommended as first choice drug therapy by the American College of Obstetricians and Gynecologists (ACOG) Guidelines and is supported by extensive international literature. 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.

Official Title
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Prevalence And Burden Of Nausea And Vomiting In Pregnant Women. An Italian Survey (PURITY)

Conditions
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Nausea Gravidarum, Vomiting of Pregnancy

Intervention / Treatment
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* Other: Survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian women in physiological pregnancy and between the 18th and 22nd week (time of morphological ultrasound). 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: Twin pregnancy. Medically assisted procreation (MAP)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>600 Pregnant women between the 18th and 22nd week. 200 from Northern Italy; 200 from Central Italy; 200 from Southern Italy and the Islands. | Other: Survey<br>* Observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NVP prevalence. | Nausea, vomiting pregnancy prevalence | 18 to 22 weeks | 
| Percentage of cases based on PUQE | Percentage of mild, medium and severe cases based on PUQE. | 18 to 22 weeks | 
| NVP related questions | Percentage of answer allocation to Nausea Vomiting Pregnancy related questions | 18 to 22 weeks | 
| Mean and SD of onset for each symptom and its duration | Mean and Standard Deviation of onset for each symptom and its duration | 18 to 22 weeks | 
| Correlations between demographic data and the presence of symptoms | Correlations between demographic data (age, first pregnancy status, multiparity, geographical origin, type of work and educational qualification) and the presence of symptoms and their severity. | 18 to 22 weeks | 
| Correlation with the use of both therapies | Correlation of the use of non-pharmacological, pharmacological or both therapies with the severity of the symptoms during pregnancy and with the possible outcomes. | 18 to 22 weeks | 
| Correlation between severity of symptoms and consequences on women's personal life. | Correlation between severity of symptoms and consequences on women's personal life (family, work, etc.). | 18 to 22 weeks | 
| Number of cases with hospitalization | Number of cases with hospitalization in relation to total and severity of symptoms (PUQE). | 18 to 22 weeks | 
| Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire | Correlation between symptoms in pregnancy (and relative severity) and outcomes based on data from the post pregnancy questionnaire (weight of new-born, gestational age at birth and any complications). | 18 to 22 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Survey, Nausea of Pregnancy, Vomiting of Pregnancy, Italy, Nuperal®