Clinical trial NCT04926727: Prevalence And Burden Of Nausea And Vomiting In Pregnant Women
Official title: Prevalence And Burden Of Nausea And Vomiting In Pregnant Women. An Italian Survey (PURITY)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nausea Gravidarum
Vomiting of Pregnancy
Keywords: Nausea of Pregnancy
Vomiting of Pregnancy
Survey
Italy
Nuperal®
Lead sponsor: Italfarmaco
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2021-06-15
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women between the 18th and 22nd week. Inclusion criteria

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.


Eligibility criteria: 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)

Primary outcomes:
measure: NVP prevalence.
timeFrame: 18 to 22 weeks
measure: Percentage of cases based on PUQE
timeFrame: 18 to 22 weeks
measure: NVP related questions
timeFrame: 18 to 22 weeks
measure: Mean and SD of onset for each symptom and its duration
timeFrame: 18 to 22 weeks
measure: Correlations between demographic data and the presence of symptoms
timeFrame: 18 to 22 weeks
measure: Correlation with the use of both therapies
timeFrame: 18 to 22 weeks
measure: Correlation between severity of symptoms and consequences on women's personal life.
timeFrame: 18 to 22 weeks
measure: Number of cases with hospitalization
timeFrame: 18 to 22 weeks
measure: Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire
timeFrame: 18 to 22 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Policlinico di Napoli - Università di Napoli "Federico II"
state: Corso Umberto I 40
city: Chieti
country: Italy
facility: P.O. SS.ma Annunziata di Chieti della ASL di Chieti
state: Via Dei Vestini
city: Milano
country: Italy
facility: Ospedale dei Bambini "Vittore Buzzi"
state: Via Lodovico Castelvetro, 32
Study officials:
References: