He Study Focuses on Evaluating Current Clinical Practices Rather Than Testing an InterventionNCT06841029
Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum: Evaluation of Clinical Practices in Five Maternity Hospitals in Île-de-France
An observational study of He Study Focuses on Evaluating Current Clinical Practices Rather Than Testing an Intervention, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
This clinical trial aims to evaluate the adequacy of healthcare professionals' clinical practices regarding nausea and vomiting in pregnancy (NVP) and hyperemesis gravidarum (HG) with the recommendations of the National College of French Obstetricians and Gynecologists (CNGOF). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- He Study Focuses on Evaluating Current Clinical Practices Rather Than Testing an Intervention
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2023to 15 Mar 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consisted of 117 healthcare professionals from five maternity hospitals in Île-de-France, of which 104 responses were usable. The participants included: 68 midwives (65.4%) 27 obstetrician-gynecologists (26%) 9 gynecology-obstetrics interns (8.6%) The distribution across hospitals was as follows: Center A: 45 respondents (21 midwives, 17 obstetrician-gynecologists, 7 interns) Center B: 17 respondents (all midwives) Center C: 15 respondents (12 midwives, 3 obstetrician-gynecologists) Center D: 15 respondents (9 midwives, 4 obstetrician-gynecologists, 2 interns) Center E: 12 respondents (9 midwives, 3 obstetrician-gynecologists)
Who may be able to join
- Midwives, obstetrician-gynecologists, and gynecology-obstetrics interns working in the labor and delivery units, high-risk pregnancy units, and obstetric-gynecological emergency units of the five selected maternity hospitals.
Who cannot join
- Midwives or doctors in training (student midwives or medical externs)
- Midwives and obstetrician-gynecologists working in private practice
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial aims to evaluate the adequacy of healthcare professionals' clinical practices regarding nausea and vomiting in pregnancy (NVP) and hyperemesis gravidarum (HG) with the recommendations of the National College of French Obstetricians and Gynecologists (CNGOF). The study involves 117 participants and follows an observational, cross-sectional, multicenter study design conducted in five maternity hospitals in Île-de-France.
- Conditions
- He Study Focuses on Evaluating Current Clinical Practices Rather Than Testing an Intervention
- Keywords
- NVP, hyperemesis gravidarum, clinical practices, adequacy, recommendations,CNGOF
- Medical subject headings
- Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Midwives | Midwives involved in the care of patients suffering from nausea and vomiting of pregnancy and hypermesis gravidarum | |
| Obstetrician-Gynecologists | Obstetrician-Gynecologists involved in the care of patients suffering from nausea and vomiting of pregnancy and hypermesis gravidarum | |
| Gynecology-Obstetrics Interns | Gynecology-Obstetrics involved in the care of patients suffering from nausea and vomiting of pregnancy and hypermesis gravidarum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of healthcare professionals whose management of NVP and HG aligns with CNGOF recommendations.
Measured: data collection period: October 2023-March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start15 Oct 2023
- Primary completion1 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for He Study Focuses on Evaluating Current Clinical Practices Rather Than Testing an InterventionStudies 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
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841029
- Sponsor's protocol ID
- 0051_MATERNITE_
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum: Evaluation of Clinical Practices in Five Maternity Hospitals in Île-de-France
- ClinicalTrials.gov ID
- NCT06841029
- Acronym / sponsor ID
- 0051_MATERNITE_
- Conditions
- He Study Focuses on Evaluating Current Clinical Practices Rather Than Testing an Intervention
- Keywords
- NVP, hyperemesis gravidarum, clinical practices, adequacy, recommendations,CNGOF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 21 Feb 2025 (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.
This clinical trial aims to evaluate the adequacy of healthcare professionals' clinical practices regarding nausea and vomiting in pregnancy (NVP) and hyperemesis gravidarum (HG) with the recommendations of the National College of French Obstetricians and Gynecologists (CNGOF). The study involves 117 participants and follows an observational, cross-sectional, multicenter study design conducted in five maternity hospitals in Île-de-France.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Midwives | – | –Midwives involved in the care of patients suffering from nausea and vomiting of pregnancy and hypermesis gravidarum |
| Obstetrician-Gynecologists | – | –Obstetrician-Gynecologists involved in the care of patients suffering from nausea and vomiting of pregnancy and hypermesis gravidarum |
| Gynecology-Obstetrics Interns | – | –Gynecology-Obstetrics involved in the care of patients suffering from nausea and vomiting of pregnancy and hypermesis gravidarum |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consisted of 117 healthcare professionals from five maternity hospitals in Île-de-France, of which 104 responses were usable. The participants included: 68 midwives (65.4%) 27 obstetrician-gynecologists (26%) 9 gynecology-obstetrics interns (8.6%) The distribution across hospitals was as follows: Center A: 45 respondents (21 midwives, 17 obstetrician-gynecologists, 7 interns) Center B: 17 respondents (all midwives) Center C: 15 respondents (12 midwives, 3 obstetrician-gynecologists) Center D: 15 respondents (9 midwives, 4 obstetrician-gynecologists, 2 interns) Center E: 12 respondents (9 midwives, 3 obstetrician-gynecologists)
Key inclusion criteria (1 listed)
- Midwives, obstetrician-gynecologists, and gynecology-obstetrics interns working in the labor and delivery units, high-risk pregnancy units, and obstetric-gynecological emergency units of the five selected maternity hospitals.
Key exclusion criteria (2 listed)
- Midwives or doctors in training (student midwives or medical externs)
- Midwives and obstetrician-gynecologists working in private practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of healthcare professionals whose management of NVP and HG aligns with CNGOF recommendations.
Time frame: data collection period: October 2023-March 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of He Study Focuses on Evaluating Current Clinical Practices Rather Than Testing an Intervention, run by Centre Hospitalier de Saint-Denis at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of healthcare professionals whose management of NVP and HG aligns with CNGOF recommendations. (time frame: data collection period: October 2023-March 2024). 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 24 Feb 2025.