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

Study acronym: French-HELP
StatusNot Yet Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Nov 2028 → Feb 2029
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Record History

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  1. Notable Start date: Aug 2026 to Nov 2026
    • Primary and study completion pushed from Nov 2028 to Feb 2029
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 9 of 23 entries
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07767071
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions
(from sponsor)
Hyperemesis Gravidarum, Nausea and Vomiting of Pregnancy
Related terms Hyperemesis Gravidarum, Nausea
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov