Nausea Gravidarum, Vomiting of Pregnancy
Conditions
Keywords
Nausea of Pregnancy, Vomiting of Pregnancy, Survey, Italy, Nuperal®
Brief summary
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.
Interventions
OTHERSurvey
Observational study
Sponsors
Opera CRO, a TIGERMED Group Company
Italfarmaco
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NVP prevalence. | 18 to 22 weeks | Nausea, vomiting pregnancy prevalence |
| Percentage of cases based on PUQE | 18 to 22 weeks | Percentage of mild, medium and severe cases based on PUQE. |
| NVP related questions | 18 to 22 weeks | Percentage of answer allocation to Nausea Vomiting Pregnancy related questions |
| Mean and SD of onset for each symptom and its duration | 18 to 22 weeks | Mean and Standard Deviation of onset for each symptom and its duration |
| Correlations between demographic data and the presence of symptoms | 18 to 22 weeks | 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. |
| Correlation with the use of both therapies | 18 to 22 weeks | Correlation of the use of non-pharmacological, pharmacological or both therapies with the severity of the symptoms during pregnancy and with the possible outcomes. |
| Correlation between severity of symptoms and consequences on women's personal life. | 18 to 22 weeks | Correlation between severity of symptoms and consequences on women's personal life (family, work, etc.). |
| Number of cases with hospitalization | 18 to 22 weeks | Number of cases with hospitalization in relation to total and severity of symptoms (PUQE). |
| Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire | 18 to 22 weeks | 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). |
Countries
Italy
Contacts
Primary ContactDionisio F Barattini, MD Europe, Opera CRO
Backup ContactSimone Guadagna, Clinical Project Manager
Outcome results
None listed