Prevalence And Burden Of Nausea And Vomiting In Pregnant Women

NCT04926727 | Unknown

• 1 other identifier: OPITA/0120/SU
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

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.

Conditions

Nausea Gravidarum; Vomiting of Pregnancy

Keywords

Nausea of Pregnancy; Vomiting of Pregnancy; Survey; Italy; Nuperal®

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

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

Interventions

Survey OTHER

Observational study

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Caucasian women in physiological pregnancy between the 18th and 22nd week (time of morphological ultrasound).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Twin pregnancy.
• Medically assisted procreation (MAP)

Sponsors & Collaborators

• Italfarmaco: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (3)

Policlinico di Napoli - Università di Napoli "Federico II"

Napoli, Corso Umberto I 40, 80138, Italy

Location

P.O. SS.ma Annunziata di Chieti della ASL di Chieti

Chieti, Via Dei Vestini, 66100, Italy

Location

Ospedale dei Bambini "Vittore Buzzi"

Milan, Via Lodovico Castelvetro, 32, 20154, Italy

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Dionisio F Barattini, MD Europe, Opera CRO

CONTACT

+39 3355437574; franco.barattini@tigermedgrp.com

Simone Guadagna, Clinical Project Manager

CONTACT

+39 3511251844; simone.guadagna@tigermedgrp.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 15, 2021
• Study Start: October 4, 2021
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

IT (3)