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Can a new score catch severe pregnancy sickness that others miss?

NCT ID NCT07767071

Diagnosis Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This study evaluates whether a French version of the HELP score can more accurately diagnose hyperemesis gravidarum (HG), a severe form of nausea and vomiting in pregnancy, compared to the standard PUQE score. Researchers will enroll 300 pregnant women experiencing nausea or vomiting in their first trimester and compare the diagnostic accuracy of both tools. The HELP score includes questions about hydration, diet, treatment effectiveness, and quality of life, which may better capture the full impact of HG. The goal is to see if this tool can better identify women who need medical intervention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HELP score questionnaire
What this could lead to
If validated, the French HELP scale could give doctors a more accurate tool to spot severe hyperemesis gravidarum, leading to earlier and better care for affected pregnancies.
What could go wrong
This is a validation study, not a treatment trial, so it won't directly improve outcomes. The scale may not prove more accurate than existing tools, and results may not apply beyond the French-speaking population studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hyperemesis gravidarum Nausea

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperemesis gravidarum Nausea and vomiting of pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH de Béziers

    Béziers, France

  • CH de Mende

    Mende, France

  • CH de Sète

    Sète, France

  • CHU de Montpellier

    Montpellier, France

  • CHU de Nîmes

    Nîmes, 30029, France

  • CHU de Toulouse

    Toulouse, France

  • Centre Hospitalier Alès-Cévennes

    Alès, France

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