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

August 11, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Women with HG
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum
Time Frame: Month 21
Month 21
Area under the curve for the PUQE score to diagnose hyperemesis gravidarum
Time Frame: Month 21
Month 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the curve for the FRENCH HELP score to diagnose severe hyperemesis gravidarum
Time Frame: Month 21
Month 21
Area under the curve for the PUQE score to diagnose severe hyperemesis gravidarum
Time Frame: Month 21
Month 21
Discordance rate between FRENCH HELP and PUQE
Time Frame: 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
Time Frame: Month 21
percentage (%)
Month 21
Predictive values of FRENCH HELP score on miscarriage
Time Frame: Month 21
Classed as pregnancy loss before 15 weeks of gestation
Month 21
Predictive values of PUQE score on miscarriage
Time Frame: Month 21
Classed as pregnancy loss before 15 weeks of gestation
Month 21
Newborn small for gestational age
Time Frame: At birth (Max 9 months)
Classed as birth weight < 10th percentile
At birth (Max 9 months)
Preterm birth
Time Frame: At birth (Max 37 weeks)
Classed as delivery before 37 weeks of gestation
At birth (Max 37 weeks)
Gestational hypertension
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
Before birth (max 9 months)
Pre-eclampsia
Time Frame: Before birth (max Month 9)
Classed as gestational hypertension and proteinuria >0.3 g/24 hours
Before birth (max Month 9)
Labor characteristics
Time Frame: 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
Time Frame: At birth (max month 9)
Yes/no
At birth (max month 9)
Birth weight
Time Frame: At birth (max 9 months)
grams
At birth (max 9 months)
newborn Apgar score < 7
Time Frame: At birth (max 9 months)
Yes/no
At birth (max 9 months)
Umbilical cord blood pH
Time Frame: At birth (max 9 months)
At birth (max 9 months)
Umbilical cord blood PCO2
Time Frame: At birth (max 9 months)
mmHg
At birth (max 9 months)
Umbilical cord blood PO2
Time Frame: At birth (max 9 months)
mmHg
At birth (max 9 months)
lactate levels in umbilical arterial blood
Time Frame: At birth (max 9 months)
mmol/L
At birth (max 9 months)
newborns transferred to a neonatal unit
Time Frame: At birth (max 9 months)
Yes/no
At birth (max 9 months)
presence of a congenital malformation
Time Frame: At birth (max 9 months)
Yes/no
At birth (max 9 months)
presence of depression
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.
Month 9
Convergent validity of FRENCH HELP against PUQE score
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.
Month 21
Convergent validity of FRENCH HELP against WHOQOL quality-of-life score
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").
Month 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephanie Huberlant, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AOI GCS/2025/S

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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