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Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum (French-HELP)

11 août 2026 mis à jour par: Centre Hospitalier Universitaire de Nīmes

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

300

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • France
      • Alès, France
        • Centre Hospitalier Alès-Cévennes
        • Contact:
      • Béziers, France
      • Mende, France
      • Montpellier, France
      • Nîmes, France, 30029
        • CHU de Nîmes
        • Contact:
          • Anissa Megzari
          • Numéro de téléphone: 04.66.68.42.36
          • E-mail: drc@chu-nimes.fr
      • Sète, France
      • Toulouse, France

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Pregnant women with nausea or vomiting that began before 16 weeks of gestation with no other identifiable cause

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Women with HG
Autre: HELP score
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
Women with severe HG
Autre: HELP score
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum
Délai: Month 21
Month 21
Area under the curve for the PUQE score to diagnose hyperemesis gravidarum
Délai: Month 21
Month 21

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Area under the curve for the FRENCH HELP score to diagnose severe hyperemesis gravidarum
Délai: Month 21
Month 21
Area under the curve for the PUQE score to diagnose severe hyperemesis gravidarum
Délai: Month 21
Month 21
Discordance rate between FRENCH HELP and PUQE
Délai: Month 21
Percentage of women reclassified as severe using the HELP score who were not classified as such using the PUQE score
Month 21
Rate of women whose management would have been altered by using the HELP score
Délai: Month 21
percentage (%)
Month 21
Predictive values of FRENCH HELP score on miscarriage
Délai: Month 21
Classed as pregnancy loss before 15 weeks of gestation
Month 21
Predictive values of PUQE score on miscarriage
Délai: Month 21
Classed as pregnancy loss before 15 weeks of gestation
Month 21
Newborn small for gestational age
Délai: At birth (Max 9 months)
Classed as birth weight < 10th percentile
At birth (Max 9 months)
Preterm birth
Délai: At birth (Max 37 weeks)
Classed as delivery before 37 weeks of gestation
At birth (Max 37 weeks)
Gestational hypertension
Délai: Before birth (max 9 months)
Classed as blood pressure >140 mmHg systolic and/or 90 mmHg diastolic occurring after 20 weeks of gestation
Before birth (max 9 months)
Pre-eclampsia
Délai: Before birth (max Month 9)
Classed as gestational hypertension and proteinuria >0.3 g/24 hours
Before birth (max Month 9)
Labor characteristics
Délai: At birth (Max Month 9)
Classed as: spontaneous labor, induction, cesarean section, instrumental delivery, postpartum hemorrhage
At birth (Max Month 9)
Fetal heart rate abnormalities during labor
Délai: At birth (max month 9)
Yes/no
At birth (max month 9)
Birth weight
Délai: At birth (max 9 months)
grams
At birth (max 9 months)
newborn Apgar score < 7
Délai: At birth (max 9 months)
Yes/no
At birth (max 9 months)
Umbilical cord blood pH
Délai: At birth (max 9 months)
At birth (max 9 months)
Umbilical cord blood PCO2
Délai: At birth (max 9 months)
mmHg
At birth (max 9 months)
Umbilical cord blood PO2
Délai: At birth (max 9 months)
mmHg
At birth (max 9 months)
lactate levels in umbilical arterial blood
Délai: At birth (max 9 months)
mmol/L
At birth (max 9 months)
newborns transferred to a neonatal unit
Délai: At birth (max 9 months)
Yes/no
At birth (max 9 months)
presence of a congenital malformation
Délai: At birth (max 9 months)
Yes/no
At birth (max 9 months)
presence of depression
Délai: 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.
Month 9
Convergent validity of FRENCH HELP against PUQE score
Délai: Month 21
PUQE score - 3 questions regarding nausea, vomiting, and retching, scored from 1 to 15, where score is ≥ 13 is classified as severe.
Month 21
Convergent validity of FRENCH HELP against WHOQOL quality-of-life score
Délai: 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").
Month 21

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Centre Hospitalier Universitaire de Nīmes

Les enquêteurs

  • Chercheur principal: Stephanie Huberlant, Centre Hospitalier Universitaire de Nîmes

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 novembre 2028

Achèvement de l'étude (Estimé)

1 novembre 2028

Dates d'inscription aux études

Première soumission

11 août 2026

Première soumission répondant aux critères de contrôle qualité

11 août 2026

Première publication (Réel)

17 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AOI GCS/2025/S

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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