Hyperemesis GravidarumFrench-HELPNCT07767071
Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
An observational study of Hyperemesis Gravidarum and Nausea and Vomiting of Pregnancy, run by Centre Hospitalier Universitaire de Nīmes at 7 sites in France.
Trial summary
Severe forms of nausea and vomiting of pregnancy (NVP) are classified as hyperemesis gravidarum (HG). NVP is debilitating in approximately 35% of women impairing daily life and professional activities while negatively affecting family relationships. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hyperemesis Gravidarum, Nausea and Vomiting of Pregnancy
- What is being tested?
- HELP score
- How many people
- 300 participants
- Where
- 7 sitesFrance
- Study dates
- Nov 2026to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with nausea or vomiting that began before 16 weeks of gestation with no other identifiable cause
Who may be able to join
- The patient must be a member or beneficiary of a health insurance plan
- Pregnant woman with nausea or vomiting that began during the first trimester of pregnancy (before 16 weeks of gestation) with no other identifiable cause.
- Oral consent given by the participant
Who cannot join
- The subject is in a period of exclusion determined by a previous study
- The subject unable to provide consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Presence of a secondary cause for nausea and vomiting (hepatitis, pancreatitis, atypical forms of appendicitis, pyelonephritis, adnexal torsion, hyperthyroidism, or chronic treatments known to induce vomiting).
- Presence of any pre-existing medical condition or situation that could cause vomiting (restrictive bariatric surgery, eating disorders).
- Inability to complete the questionnaires (lack of French language comprehension, illiteracy, intellectual disability, etc.).
- Patient enrolled in a study evaluating a treatment intended to address nausea and vomiting.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
Centre Hospitalier Alès-Cévennes
Alès
Jeanne-Claire SIX, 04 66 78 32 21, dr.six@ch-ales.fr
CH de Béziers
Béziers
Samantha HUET, 04 67 35 76 07, samantha.huet@ch-beziers.fr
CH de Mende
Mende
Agnès PREVOST-FEREY, agnesprevostferey@ch-mende.fr
CHU de Montpellier
Montpellier
Philippe DERUELLE, 04 67 33 64 86, p-deruelle@chu-montpellier.fr
CHU de Nîmes
Nîmes, 30029
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
CH de Sète
Sète
Angela MORARU, 04 67 46 57 57, amoraru@ch-bassindethau.fr
CHU de Toulouse
Toulouse
Laure CONNAN, 5 67 77 12 33, connan.l@chu-toulouse.fr
About this study
Severe forms of nausea and vomiting of pregnancy (NVP) are classified as hyperemesis gravidarum (HG). NVP is debilitating in approximately 35% of women impairing daily life and professional activities while negatively affecting family relationships. In 0.3% to 3.6% of pregnancies, the vomiting is intractable and represents the leading cause of hospitalization during the first trimester. Severity of symptoms can sometimes lead women to consider terminating the pregnancy or to decide against future pregnancies.
The most widely used tool for assessing NVP and HG is the PUQE score; it asks three questions regarding nausea, vomiting, and retching, and is scored from 1 to 15. A score of ≥13 classifies NVP as severe. However, the PUQE score does not include questions regarding quality of life, which is a key determinant of HG.
Read more
An international definition (the Windsor definition of HG) has been developed, extending beyond mere digestive symptoms. This definition includes: symptom onset in early pregnancy (before 16 weeks of gestation); severe nausea or vomiting; an inability to eat or drink normally; and significant limitation of daily activities or signs of dehydration. This definition aligns better with the full spectrum of symptoms associated with this condition. The US-based Hyperemesis Education and Research (HER) Foundation developed the HELP Score to better assess nausea and vomiting of pregnancy (NVP), particularly severe cases. The tool includes questions regarding the intensity of nausea and vomiting, along with nine additional questions covering hydration, nutrition, treatments and their efficacy, and quality of life. The HELP score ranges from 0 to 60, with scores of 33 to 60 classifying patients as severe; this offers greater scope for assessing levels of severity, and improvement, compared to the PUQE score, which is calculated on a 15-point scale with only 3 points allocated to the severity category.
The HELP score has proved more effective than the PUQE score at identifying patients with severe symptoms requiring intervention, in a study with several methodological limitations, such as reliance on an online questionnaire and a failure to adhere to diagnostic validation standards. Nevertheless, the lack of robust evidence warrants further research using more rigorous methodology to confirm the value of this scoring system.
- Being tested
- HELP score
- Keywords
- HELP score
- Medical subject headings
- Hyperemesis Gravidarum, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELP scoreOther
Evaluation of intensity of nausea and vomiting, covering hydration, diet, treatments and their effectiveness, and quality of life. The HELP score ranges from 0 to 60-with scores of 33 to 60 classifying patients as severe
| Study group | Role | What they receive |
|---|---|---|
| Women with HG | Not described Receives: Other: HELP score | |
| Women with severe HG | Not described Receives: Other: HELP score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum
Measured: Month 21
Area under the curve for the PUQE score to diagnose hyperemesis gravidarum
Measured: Month 21
Secondary outcomes (23)
Area under the curve for the FRENCH HELP score to diagnose severe hyperemesis gravidarum
Measured: Month 21
Area under the curve for the PUQE score to diagnose severe hyperemesis gravidarum
Measured: Month 21
Discordance rate between FRENCH HELP and PUQE
Percentage of women reclassified as severe using the HELP score who were not classified as such using the PUQE score
Measured: Month 21
Rate of women whose management would have been altered by using the HELP score
percentage (%)
Measured: Month 21
Predictive values of FRENCH HELP score on miscarriage
Classed as pregnancy loss before 15 weeks of gestation
Measured: Month 21
Predictive values of PUQE score on miscarriage
Classed as pregnancy loss before 15 weeks of gestation
Measured: Month 21
Newborn small for gestational age
Classed as birth weight < 10th percentile
Measured: At birth (Max 9 months)
Preterm birth
Classed as delivery before 37 weeks of gestation
Measured: At birth (Max 37 weeks)
Gestational hypertension
Classed as blood pressure >140 mmHg systolic and/or 90 mmHg diastolic occurring after 20 weeks of gestation
Measured: Before birth (max 9 months)
Pre-eclampsia
Classed as gestational hypertension and proteinuria >0.3 g/24 hours
Measured: Before birth (max Month 9)
Labor characteristics
Classed as: spontaneous labor, induction, cesarean section, instrumental delivery, postpartum hemorrhage
Measured: At birth (Max Month 9)
Fetal heart rate abnormalities during labor
Yes/no
Measured: At birth (max month 9)
Birth weight
grams
Measured: At birth (max 9 months)
newborn Apgar score < 7
Yes/no
Measured: At birth (max 9 months)
Umbilical cord blood pH
Measured: At birth (max 9 months)
Umbilical cord blood PCO2
mmHg
Measured: At birth (max 9 months)
Umbilical cord blood PO2
mmHg
Measured: At birth (max 9 months)
lactate levels in umbilical arterial blood
mmol/L
Measured: At birth (max 9 months)
newborns transferred to a neonatal unit
Yes/no
Measured: At birth (max 9 months)
presence of a congenital malformation
Yes/no
Measured: At birth (max 9 months)
presence of depression
Measured using the Edinburgh Postnatal Depression Scale - 10 items rated on a scale of 0 to 3, resulting in a total score ranging from 0 to 30.
Measured: Month 9
Convergent validity of FRENCH HELP against PUQE score
PUQE score - 3 questions regarding nausea, vomiting, and retching, scored from 1 to 15, where score is ≥ 13 is classified as severe.
Measured: Month 21
Convergent validity of FRENCH HELP against WHOQOL quality-of-life score
WHOQOL-100 questionnaire - 26 questions measuring four domains: physical health, mental health, social relationships, and environment. Responses to each item are provided using a 5-point Likert scale ranging from 1 (e.g., "Not at all") to 5 (e.g., "Extremely"); these scores are summed and transformed to correspond to a scale ranging from 0 ("poor health-related quality of life") to 100 ("excellent health-related quality of life").
Measured: Month 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Huberlant, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767071
- Sponsor's protocol ID
- AOI GCS/2025/S
- Acronym
- French-HELP
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
- ClinicalTrials.gov ID
- NCT07767071
- Acronym / sponsor ID
- French-HELP / AOI GCS/2025/S
- Keywords
- HELP score
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 17 Aug 2026 (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.
Severe forms of nausea and vomiting of pregnancy (NVP) are classified as hyperemesis gravidarum (HG). NVP is debilitating in approximately 35% of women impairing daily life and professional activities while negatively affecting family relationships. In 0.3% to 3.6% of pregnancies, the vomiting is intractable and represents the leading cause of hospitalization during the first trimester. Severity of symptoms can sometimes lead women to consider terminating the pregnancy or to decide against future pregnancies.
The most widely used tool for assessing NVP and HG is the PUQE score; it asks three questions regarding nausea, vomiting, and retching, and is scored from 1 to 15. A score of ≥13 classifies NVP as severe. However, the PUQE score does not include questions regarding quality of life, which is a key determinant of HG.
An international definition (the Windsor definition of HG) has been developed, extending beyond mere digestive symptoms. This definition includes: symptom onset in early pregnancy (before 16 weeks of gestation); severe nausea or vomiting; an inability to eat or drink normally; and significant limitation of daily activities or signs of dehydration. This definition aligns better with the full spectrum of symptoms associated with this condition. The US-based Hyperemesis Education and Research (HER) Foundation developed the HELP Score to better assess nausea and vomiting of pregnancy (NVP), particularly severe cases. The tool includes questions regarding the intensity of nausea and vomiting, along with nine additional questions covering hydration, nutrition, treatments and their efficacy, and quality of life. The HELP score ranges from 0 to 60, with scores of 33 to 60 classifying patients as severe; this offers greater scope for assessing levels of severity, and improvement, compared to the PUQE score, which is calculated on a 15-point scale with only 3 points allocated to the severity category.
The HELP score has proved more effective than the PUQE score at identifying patients with severe symptoms requiring intervention, in a study with several methodological limitations, such as reliance on an online questionnaire and a failure to adhere to diagnostic validation standards. Nevertheless, the lack of robust evidence warrants further research using more rigorous methodology to confirm the value of this scoring system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with HG | – | Other: HELP score |
| Women with severe HG | – | Other: HELP score |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with nausea or vomiting that began before 16 weeks of gestation with no other identifiable cause
Key inclusion criteria (3 listed)
- The patient must be a member or beneficiary of a health insurance plan
- Pregnant woman with nausea or vomiting that began during the first trimester of pregnancy (before 16 weeks of gestation) with no other identifiable cause.
- Oral consent given by the participant
Key exclusion criteria (8 listed)
- The subject is in a period of exclusion determined by a previous study
- The subject unable to provide consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Presence of a secondary cause for nausea and vomiting (hepatitis, pancreatitis, atypical forms of appendicitis, pyelonephritis, adnexal torsion, hyperthyroidism, or chronic treatments known to induce vomiting).
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 |
|---|---|---|
| HELP scoreEvaluation of intensity of nausea and vomiting, covering hydration, diet, treatments and their effectiveness, and quality of life. The HELP score ranges from 0 to 60-with scores of 33 to 60 classifying patients as severe | Other | Women with HG, Women with severe HG |
Primary outcome
Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum
Time frame: Month 21
Area under the curve for the PUQE score to diagnose hyperemesis gravidarum
Time frame: Month 21
23 secondary outcomes
Area under the curve for the FRENCH HELP score to diagnose severe hyperemesis gravidarum
Time frame: Month 21
Area under the curve for the PUQE score to diagnose severe hyperemesis gravidarum
Time frame: Month 21
Discordance rate between FRENCH HELP and PUQE
Time frame: Month 21
Rate of women whose management would have been altered by using the HELP score
Time frame: Month 21
Predictive values of FRENCH HELP score on miscarriage
Time frame: Month 21
Predictive values of PUQE score on miscarriage
Time frame: Month 21
Newborn small for gestational age
Time frame: At birth (Max 9 months)
Preterm birth
Time frame: At birth (Max 37 weeks)
Gestational hypertension
Time frame: Before birth (max 9 months)
Pre-eclampsia
Time frame: Before birth (max Month 9)
Labor characteristics
Time frame: At birth (Max Month 9)
Fetal heart rate abnormalities during labor
Time frame: At birth (max month 9)
Birth weight
Time frame: At birth (max 9 months)
newborn Apgar score < 7
Time frame: At birth (max 9 months)
Umbilical cord blood pH
Time frame: At birth (max 9 months)
Umbilical cord blood PCO2
Time frame: At birth (max 9 months)
Umbilical cord blood PO2
Time frame: At birth (max 9 months)
lactate levels in umbilical arterial blood
Time frame: At birth (max 9 months)
newborns transferred to a neonatal unit
Time frame: At birth (max 9 months)
presence of a congenital malformation
Time frame: At birth (max 9 months)
presence of depression
Time frame: Month 9
Convergent validity of FRENCH HELP against PUQE score
Time frame: Month 21
Convergent validity of FRENCH HELP against WHOQOL quality-of-life score
Time frame: Month 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
Stephanie Huberlant principal investigator
Centre Hospitalier Universitaire de Nīmes
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperemesis Gravidarum and Nausea and Vomiting of Pregnancy, run by Centre Hospitalier Universitaire de Nīmes at 7 sites 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Huberlant (04 66 68 32 20, stephanie.huberlant@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum (time frame: Month 21). The study lists 2 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 20 Oct 2026.