Prevalence And Burden Of Nausea And Vomiting In Pregnant Women (PURITY)

Italfarmaco

Status: Unknown

Conditions: Nausea Gravidarum; Vomiting of Pregnancy

Treatments: Other: Survey

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04926727

OPITA/0120/SU

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

600 participants in 1 patient group

Pregnant women

Description:

600 Pregnant women between the 18th and 22nd week. * 200 from Northern Italy; * 200 from Central Italy; * 200 from Southern Italy and the Islands.

Treatment:

Other: Survey