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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • HELP score

    Other intervention

    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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Women with HG1 intervention
Group B: Women with severe HG1 intervention

Trial outcomes

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

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

Time frame
Month 21
4

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

percentage (%)

Time frame
Month 21

Other outcomes

Sponsors and contacts

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