Prevalence And Burden Of Nausea And Vomiting In Pregnant Women

Nausea Gravidarum Clinical Trial

— PURITY  

Official title:

Prevalence And Burden Of Nausea And Vomiting In Pregnant Women. An Italian Survey (PURITY)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04926727
• Other study ID #: OPITA/0120/SU
• Status: Not yet recruiting
• Start date: October 4, 2021
• Est. completion date: May 2022

Study information

• Verified date: September 2021
• Source: Italfarmaco
• Contact: Dionisio F Barattini, MD Europe, Opera CRO
• Phone: +39 3355437574
• Email: franco.barattini[@]tigermedgrp.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Nausea
• Nausea Gravidarum
• Vomiting
• Vomiting of Pregnancy

Intervention

Other:
• Survey
Observational study

Locations

Country	Name	City	State
Italy	P.O. SS.ma Annunziata di Chieti della ASL di Chieti	Chieti	Via Dei Vestini
Italy	Ospedale dei Bambini "Vittore Buzzi"	Milano	Via Lodovico Castelvetro, 32
Italy	Policlinico di Napoli - Università di Napoli "Federico II"	Napoli	Corso Umberto I 40

Sponsors (2)

Lead Sponsor	Collaborator
Italfarmaco	Opera Contract Research Organization a Tigermed company

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NVP prevalence.	Nausea, vomiting pregnancy prevalence	18 to 22 weeks
Primary	Percentage of cases based on PUQE	Percentage of mild, medium and severe cases based on PUQE.	18 to 22 weeks
Primary	NVP related questions	Percentage of answer allocation to Nausea Vomiting Pregnancy related questions	18 to 22 weeks
Primary	Mean and SD of onset for each symptom and its duration	Mean and Standard Deviation of onset for each symptom and its duration	18 to 22 weeks
Primary	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.	18 to 22 weeks
Primary	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.	18 to 22 weeks
Primary	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.).	18 to 22 weeks
Primary	Number of cases with hospitalization	Number of cases with hospitalization in relation to total and severity of symptoms (PUQE).	18 to 22 weeks
Primary	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).	18 to 22 weeks