Nausea GravidarumPURITYNCT04926727
Prevalence And Burden Of Nausea And Vomiting In Pregnant Women
An observational study of Nausea Gravidarum and Vomiting of Pregnancy, run by Italfarmaco at 3 sites in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nausea Gravidarum, Vomiting of Pregnancy
- What is being tested?
- Survey
- How many people
- 600 participants
- Where
- 3 sitesItaly
- Study dates
- 4 Oct 2021to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women between the 18th and 22nd week. Inclusion criteria
Who may be able to join
- 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.
Who cannot join
- Twin pregnancy.
- Medically assisted procreation (MAP)
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
P.O. SS.ma Annunziata di Chieti della ASL di Chieti
Chieti, Via Dei Vestini, 66100
Ospedale dei Bambini "Vittore Buzzi"
Milan, Via Lodovico Castelvetro, 32, 20154
Policlinico di Napoli - Università di Napoli "Federico II"
Naples, Corso Umberto I 40, 80138
About this study
Official title: 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.
Read more
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
- Being tested
- Survey
- Keywords
- Nausea of Pregnancy, Vomiting of Pregnancy, Survey, Italy, Nuperal®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
NVP prevalence.
Nausea, vomiting pregnancy prevalence
Measured: 18 to 22 weeks
Percentage of cases based on PUQE
Percentage of mild, medium and severe cases based on PUQE.
Measured: 18 to 22 weeks
NVP related questions
Percentage of answer allocation to Nausea Vomiting Pregnancy related questions
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.).
Measured: 18 to 22 weeks
Number of cases with hospitalization
Number of cases with hospitalization in relation to total and severity of symptoms (PUQE).
Measured: 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).
Measured: 18 to 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start4 Oct 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Italfarmaco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926727
- Sponsor's protocol ID
- OPITA/0120/SU
- Acronym
- PURITY
- Status last verified
- Sep 2021
- First submitted
- 10 Jun 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence And Burden Of Nausea And Vomiting In Pregnant Women. An Italian Survey (PURITY)
- ClinicalTrials.gov ID
- NCT04926727
- Acronym / sponsor ID
- PURITY / OPITA/0120/SU
- Conditions
- Nausea Gravidarum, Vomiting of Pregnancy
- Keywords
- Nausea of Pregnancy, Vomiting of Pregnancy, Survey, Italy, Nuperal®
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- ItalfarmacoIndustry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 4 Oct 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Survey600 Pregnant women between the 18th and 22nd week. * 200 from Northern Italy; * 200 from Central Italy; * 200 from Southern Italy and the Islands. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women between the 18th and 22nd week. Inclusion criteria
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Twin pregnancy.
- Medically assisted procreation (MAP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyObservational study | Other | Pregnant women |
Primary outcome
NVP prevalence.
Time frame: 18 to 22 weeks
Nausea, vomiting pregnancy prevalence
Percentage of cases based on PUQE
Time frame: 18 to 22 weeks
Percentage of mild, medium and severe cases based on PUQE.
NVP related questions
Time frame: 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
Time frame: 18 to 22 weeks
Mean and Standard Deviation of onset for each symptom and its duration
Correlations between demographic data and the presence of symptoms
Time frame: 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.
Correlation with the use of both therapies
Time frame: 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.
Time frame: 18 to 22 weeks
Correlation between severity of symptoms and consequences on women's personal life (family, work, etc.).
Number of cases with hospitalization
Time frame: 18 to 22 weeks
Number of cases with hospitalization in relation to total and severity of symptoms (PUQE).
Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Nausea Gravidarum
Not yet recruitingObservational study
Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
Hyperemesis Gravidarum, Nausea and Vomiting of Pregnancy
RecruitingPhase 1/2
Hyperemesis Gravidarum Risk Reduction With Metformin
Hyperemesis Gravidarum
Not yet recruiting
Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy
Nausea Gravidarum, Hyperemesis Gravidarum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea Gravidarum and Vomiting of Pregnancy, run by Italfarmaco at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dionisio F Barattini, MD Europe, Opera CRO (+39 3355437574, franco.barattini@tigermedgrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NVP prevalence. (time frame: 18 to 22 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.