Prevalence And Burden Of Nausea And Vomiting In Pregnant Women

• Conditions: Vomiting of Pregnancy; Nausea Gravidarum

• Registration Number: NCT04926727
• Lead Sponsor: Italfarmaco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05
• Study Start: 2021-10-04
• Primary Completion: 2021-12
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of cases based on PUQE	18 to 22 weeks	Percentage of mild, medium and severe cases based on PUQE.
NVP related questions	18 to 22 weeks	Percentage of answer allocation to Nausea Vomiting Pregnancy related questions
Mean and SD of onset for each symptom and its duration	18 to 22 weeks	Mean and Standard Deviation of onset for each symptom and its duration
Correlation with the use of both therapies	18 to 22 weeks	Correlation of the use of non-pharmacological, pharmacological or both therapies with the severity of the symptoms during pregnancy and with the possible outcomes.
Correlation between severity of symptoms and consequences on women's personal life.	18 to 22 weeks	Correlation between severity of symptoms and consequences on women's personal life (family, work, etc.).
Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire	18 to 22 weeks	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).
NVP prevalence.	18 to 22 weeks	Nausea, vomiting pregnancy prevalence
Number of cases with hospitalization	18 to 22 weeks	Number of cases with hospitalization in relation to total and severity of symptoms (PUQE).
Correlations between demographic data and the presence of symptoms	18 to 22 weeks	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.

Trial Locations

Locations (3)

Policlinico di Napoli - Università di Napoli "Federico II"; 🇮🇹 Napoli, Corso Umberto I 40, 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