Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum (French-HELP)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Stephanie Huberlant
- Número de teléfono: 04 66 68 32 20
- Correo electrónico: stephanie.huberlant@chu-nimes.fr
Ubicaciones de estudio
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Alès, Francia
- Centre Hospitalier Alès-Cévennes
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Contacto:
- Jeanne-Claire SIX
- Número de teléfono: 04 66 78 32 21
- Correo electrónico: dr.six@ch-ales.fr
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Béziers, Francia
- CH de Béziers
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Contacto:
- Samantha HUET
- Número de teléfono: 04 67 35 76 07
- Correo electrónico: samantha.huet@ch-beziers.fr
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Mende, Francia
- CH de Mende
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Contacto:
- Agnès PREVOST-FEREY
- Correo electrónico: agnesprevostferey@ch-mende.fr
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Montpellier, Francia
- CHU de Montpellier
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Contacto:
- Philippe DERUELLE
- Número de teléfono: 04 67 33 64 86
- Correo electrónico: p-deruelle@chu-montpellier.fr
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Nîmes, Francia, 30029
- CHU de Nîmes
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Contacto:
- Anissa Megzari
- Número de teléfono: 04.66.68.42.36
- Correo electrónico: drc@chu-nimes.fr
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Sète, Francia
- CH de Sète
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Contacto:
- Angela MORARU
- Número de teléfono: 04 67 46 57 57
- Correo electrónico: amoraru@ch-bassindethau.fr
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Toulouse, Francia
- CHU de Toulouse
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Contacto:
- Laure CONNAN
- Número de teléfono: 5 67 77 12 33
- Correo electrónico: connan.l@chu-toulouse.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Women with HG
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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
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Women with severe HG
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum
Periodo de tiempo: Month 21
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Month 21
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Area under the curve for the PUQE score to diagnose hyperemesis gravidarum
Periodo de tiempo: Month 21
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Month 21
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Area under the curve for the FRENCH HELP score to diagnose severe hyperemesis gravidarum
Periodo de tiempo: Month 21
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Month 21
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Area under the curve for the PUQE score to diagnose severe hyperemesis gravidarum
Periodo de tiempo: Month 21
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Month 21
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Discordance rate between FRENCH HELP and PUQE
Periodo de tiempo: Month 21
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Percentage of women reclassified as severe using the HELP score who were not classified as such using the PUQE score
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Month 21
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Rate of women whose management would have been altered by using the HELP score
Periodo de tiempo: Month 21
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percentage (%)
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Month 21
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Predictive values of FRENCH HELP score on miscarriage
Periodo de tiempo: Month 21
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Classed as pregnancy loss before 15 weeks of gestation
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Month 21
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Predictive values of PUQE score on miscarriage
Periodo de tiempo: Month 21
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Classed as pregnancy loss before 15 weeks of gestation
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Month 21
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Newborn small for gestational age
Periodo de tiempo: At birth (Max 9 months)
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Classed as birth weight < 10th percentile
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At birth (Max 9 months)
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Preterm birth
Periodo de tiempo: At birth (Max 37 weeks)
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Classed as delivery before 37 weeks of gestation
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At birth (Max 37 weeks)
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Gestational hypertension
Periodo de tiempo: Before birth (max 9 months)
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Classed as blood pressure >140 mmHg systolic and/or 90 mmHg diastolic occurring after 20 weeks of gestation
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Before birth (max 9 months)
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Pre-eclampsia
Periodo de tiempo: Before birth (max Month 9)
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Classed as gestational hypertension and proteinuria >0.3 g/24 hours
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Before birth (max Month 9)
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Labor characteristics
Periodo de tiempo: At birth (Max Month 9)
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Classed as: spontaneous labor, induction, cesarean section, instrumental delivery, postpartum hemorrhage
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At birth (Max Month 9)
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Fetal heart rate abnormalities during labor
Periodo de tiempo: At birth (max month 9)
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Yes/no
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At birth (max month 9)
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Birth weight
Periodo de tiempo: At birth (max 9 months)
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grams
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At birth (max 9 months)
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newborn Apgar score < 7
Periodo de tiempo: At birth (max 9 months)
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Yes/no
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At birth (max 9 months)
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Umbilical cord blood pH
Periodo de tiempo: At birth (max 9 months)
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At birth (max 9 months)
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Umbilical cord blood PCO2
Periodo de tiempo: At birth (max 9 months)
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mmHg
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At birth (max 9 months)
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Umbilical cord blood PO2
Periodo de tiempo: At birth (max 9 months)
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mmHg
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At birth (max 9 months)
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lactate levels in umbilical arterial blood
Periodo de tiempo: At birth (max 9 months)
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mmol/L
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At birth (max 9 months)
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newborns transferred to a neonatal unit
Periodo de tiempo: At birth (max 9 months)
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Yes/no
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At birth (max 9 months)
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presence of a congenital malformation
Periodo de tiempo: At birth (max 9 months)
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Yes/no
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At birth (max 9 months)
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presence of depression
Periodo de tiempo: Month 9
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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.
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Month 9
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Convergent validity of FRENCH HELP against PUQE score
Periodo de tiempo: Month 21
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PUQE score - 3 questions regarding nausea, vomiting, and retching, scored from 1 to 15, where score is ≥ 13 is classified as severe.
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Month 21
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Convergent validity of FRENCH HELP against WHOQOL quality-of-life score
Periodo de tiempo: Month 21
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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").
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Month 21
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stephanie Huberlant, Centre Hospitalier Universitaire de Nîmes
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AOI GCS/2025/S
Información sobre medicamentos y dispositivos, documentos del estudio
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