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.
Age range
18 Years
Sex
FEMALE
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NVP prevalence.
Timeframe: 18 to 22 weeks
Percentage of cases based on PUQE
Timeframe: 18 to 22 weeks
NVP related questions
Timeframe: 18 to 22 weeks
Mean and SD of onset for each symptom and its duration
Timeframe: 18 to 22 weeks
Correlations between demographic data and the presence of symptoms
Timeframe: 18 to 22 weeks
Correlation with the use of both therapies
Timeframe: 18 to 22 weeks
Correlation between severity of symptoms and consequences on women's personal life.
Timeframe: 18 to 22 weeks
Number of cases with hospitalization
Dionisio F Barattini, MD Europe, Opera CRO
Timeframe: 18 to 22 weeks
Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire
Timeframe: 18 to 22 weeks