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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nausea Gravidarum; Vomiting of Pregnancy
• Intervention / Treatment: Other: Survey

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Dionisio F Barattini, MD Europe, Opera CRO; Phone Number: +39 3355437574; Email: franco.barattini@tigermedgrp.com
• Study Contact Backup: Name: Simone Guadagna, Clinical Project Manager; Phone Number: +39 3511251844; Email: simone.guadagna@tigermedgrp.com

Study Locations

• Italy
  • Corso Umberto I 40
    • Napoli, Corso Umberto I 40, Italy, 80138
      • Policlinico di Napoli - Università di Napoli "Federico II"
  • Via Dei Vestini
    • Chieti, Via Dei Vestini, Italy, 66100
      • P.O. SS.ma Annunziata di Chieti della ASL di Chieti
  • Via Lodovico Castelvetro, 32
    • Milano, Via Lodovico Castelvetro, 32, Italy, 20154
      • Ospedale dei Bambini "Vittore Buzzi"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women between the 18th and 22nd week. Inclusion criteria

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women; 600 Pregnant women between the 18th and 22nd week.; 200 from Northern Italy;; 200 from Central Italy;; 200 from Southern Italy and the Islands.	Other: Survey; Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NVP prevalence.	Nausea, vomiting pregnancy prevalence	18 to 22 weeks
Percentage of cases based on PUQE	Percentage of mild, medium and severe cases based on PUQE.	18 to 22 weeks
NVP related questions	Percentage of answer allocation to Nausea Vomiting Pregnancy related questions	18 to 22 weeks
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
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
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
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
Number of cases with hospitalization	Number of cases with hospitalization in relation to total and severity of symptoms (PUQE).	18 to 22 weeks
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

Collaborators and Investigators

• Sponsor: Italfarmaco
• Collaborators: Opera CRO, a TIGERMED Group Company

Study record dates

Study Major Dates

• Study Start (Anticipated): October 4, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Survey; Italy; Nausea of Pregnancy; Vomiting of Pregnancy; Nuperal®
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: OPITA/0120/SU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No