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

N/ANot Yet RecruitingNCT07767071

Centre Hospitalier Universitaire de Nīmes300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Centre Hospitalier Alès-Cévennes

Alès, France

CH de Béziers

Béziers, France

CH de Mende

Mende, France

CHU de Montpellier

Montpellier, France

CHU de Nîmes

Nîmes, France

CH de Sète

Sète, France

CHU de Toulouse

Toulouse, France

Outcomes

Primary Outcomes

Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum

Time frame: Month 21

Area under the curve for the PUQE score to diagnose hyperemesis gravidarum

Time frame: Month 21

Secondary Outcomes

Area under the curve for the FRENCH HELP score to diagnose severe hyperemesis gravidarum

Time frame: Month 21

Area under the curve for the PUQE score to diagnose severe hyperemesis gravidarum

Time frame: Month 21

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

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

percentage (%)

Time frame: Month 21

Predictive values of FRENCH HELP score on miscarriage

Classed as pregnancy loss before 15 weeks of gestation

Time frame: Month 21

Predictive values of PUQE score on miscarriage

Classed as pregnancy loss before 15 weeks of gestation

Time frame: Month 21

Newborn small for gestational age

Classed as birth weight \< 10th percentile

Time frame: At birth (Max 9 months)

Preterm birth

Classed as delivery before 37 weeks of gestation

Time frame: At birth (Max 37 weeks)

Gestational hypertension

Classed as blood pressure \>140 mmHg systolic and/or 90 mmHg diastolic occurring after 20 weeks of gestation

Time frame: Before birth (max 9 months)

Pre-eclampsia

Classed as gestational hypertension and proteinuria \>0.3 g/24 hours

Time frame: Before birth (max Month 9)

Labor characteristics

Classed as: spontaneous labor, induction, cesarean section, instrumental delivery, postpartum hemorrhage

Time frame: At birth (Max Month 9)

Fetal heart rate abnormalities during labor

Yes/no

Time frame: At birth (max month 9)

Birth weight

grams