HELP score
OtherEvaluation 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
NCT Number: NCT07767071
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 opening soon.
Get Notified18 year and older
Female
Observational
Centre Hospitalier Alès-Cévennes, Alès, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Month 21
Time frame: Month 21
Time frame: Month 21
Time frame: Month 21
Time frame: Month 21
Percentage of women reclassified as severe using the HELP score who were not classified as such using the PUQE score
Time frame: Month 21
percentage (%)
Time frame: Month 21
Classed as pregnancy loss before 15 weeks of gestation
Time frame: Month 21
Classed as pregnancy loss before 15 weeks of gestation
Time frame: At birth (Max 9 months)
Classed as birth weight < 10th percentile
Time frame: At birth (Max 37 weeks)
Classed as delivery before 37 weeks of gestation
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
Time frame: Before birth (max Month 9)
Classed as gestational hypertension and proteinuria >0.3 g/24 hours
Time frame: At birth (Max Month 9)
Classed as: spontaneous labor, induction, cesarean section, instrumental delivery, postpartum hemorrhage
Time frame: At birth (max month 9)
Yes/no
Time frame: At birth (max 9 months)
grams
Time frame: At birth (max 9 months)
Yes/no
Time frame: At birth (max 9 months)
Time frame: At birth (max 9 months)
mmHg
Time frame: At birth (max 9 months)
mmHg
Time frame: At birth (max 9 months)
mmol/L
Time frame: At birth (max 9 months)
Yes/no
Time frame: At birth (max 9 months)
Yes/no
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.
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.
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").
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nīmes
Other
Acronym: French-HELP
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