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.
Study Type
OBSERVATIONAL
Enrollment
600
Observational study
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
NVP prevalence.
Nausea, vomiting pregnancy prevalence
Time frame: 18 to 22 weeks
Percentage of cases based on PUQE
Percentage of mild, medium and severe cases based on PUQE.
Time frame: 18 to 22 weeks
NVP related questions
Percentage of answer allocation to Nausea Vomiting Pregnancy related questions
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.).
Time frame: 18 to 22 weeks
Number of cases with hospitalization
Number of cases with hospitalization in relation to total and severity of symptoms (PUQE).
Time frame: 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).
Time frame: 18 to 22 weeks
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