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NCT Number: NCT07767071

Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier Alès-Cévennes, Alès, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

HELP score

Other

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

Primary outcomes

  1. Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum

    Time frame: Month 21

  2. Area under the curve for the PUQE score to diagnose hyperemesis gravidarum

    Time frame: Month 21

Secondary outcomes

  1. Area under the curve for the FRENCH HELP score to diagnose severe hyperemesis gravidarum

    Time frame: Month 21

  2. Area under the curve for the PUQE score to diagnose severe hyperemesis gravidarum

    Time frame: Month 21

  3. Discordance rate between FRENCH HELP and PUQE

    Time frame: Month 21

    Percentage of women reclassified as severe using the HELP score who were not classified as such using the PUQE score

  4. Rate of women whose management would have been altered by using the HELP score

    Time frame: Month 21

    percentage (%)

  5. Predictive values of FRENCH HELP score on miscarriage

    Time frame: Month 21

    Classed as pregnancy loss before 15 weeks of gestation

  6. Predictive values of PUQE score on miscarriage

    Time frame: Month 21

    Classed as pregnancy loss before 15 weeks of gestation

  7. Newborn small for gestational age

    Time frame: At birth (Max 9 months)

    Classed as birth weight < 10th percentile

  8. Preterm birth

    Time frame: At birth (Max 37 weeks)

    Classed as delivery before 37 weeks of gestation

  9. Gestational hypertension

    Time frame: Before birth (max 9 months)

    Classed as blood pressure >140 mmHg systolic and/or 90 mmHg diastolic occurring after 20 weeks of gestation

  10. Pre-eclampsia

    Time frame: Before birth (max Month 9)

    Classed as gestational hypertension and proteinuria >0.3 g/24 hours

  11. Labor characteristics

    Time frame: At birth (Max Month 9)

    Classed as: spontaneous labor, induction, cesarean section, instrumental delivery, postpartum hemorrhage

  12. Fetal heart rate abnormalities during labor

    Time frame: At birth (max month 9)

    Yes/no

  13. Birth weight

    Time frame: At birth (max 9 months)

    grams

  14. newborn Apgar score < 7

    Time frame: At birth (max 9 months)

    Yes/no

  15. Umbilical cord blood pH

    Time frame: At birth (max 9 months)

  16. Umbilical cord blood PCO2

    Time frame: At birth (max 9 months)

    mmHg

  17. Umbilical cord blood PO2

    Time frame: At birth (max 9 months)

    mmHg

  18. lactate levels in umbilical arterial blood

    Time frame: At birth (max 9 months)

    mmol/L

  19. newborns transferred to a neonatal unit

    Time frame: At birth (max 9 months)

    Yes/no

  20. presence of a congenital malformation

    Time frame: At birth (max 9 months)

    Yes/no

  21. presence of depression

    Time frame: Month 9

    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.

  22. Convergent validity of FRENCH HELP against PUQE score

    Time frame: Month 21

    PUQE score - 3 questions regarding nausea, vomiting, and retching, scored from 1 to 15, where score is ≥ 13 is classified as severe.

  23. Convergent validity of FRENCH HELP against WHOQOL quality-of-life score

    Time frame: Month 21

    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").

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Huberlant

CONTACT

[email protected]

04 66 68 32 20

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: French-HELP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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