Prevalence And Burden Of Nausea And Vomiting In Pregnant Women. An Italian Survey (PURITY)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Percentage of cases based on PUQE
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Twin pregnancy.
- •Medically assisted procreation (MAP)
结局指标
主要结局
Percentage of cases based on PUQE
时间窗: 18 to 22 weeks
Percentage of mild, medium and severe cases based on PUQE.
NVP related questions
时间窗: 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
时间窗: 18 to 22 weeks
Mean and Standard Deviation of onset for each symptom and its duration
Correlation with the use of both therapies
时间窗: 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.
时间窗: 18 to 22 weeks
Correlation between severity of symptoms and consequences on women's personal life (family, work, etc.).
Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire
时间窗: 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).
NVP prevalence.
时间窗: 18 to 22 weeks
Nausea, vomiting pregnancy prevalence
Number of cases with hospitalization
时间窗: 18 to 22 weeks
Number of cases with hospitalization in relation to total and severity of symptoms (PUQE).
Correlations between demographic data and the presence of symptoms
时间窗: 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.
次要结局
未报告次要终点