Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum (French-HELP)
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Stephanie Huberlant
- Telefonszám: 04 66 68 32 20
- E-mail: stephanie.huberlant@chu-nimes.fr
Tanulmányi helyek
-
-
-
Alès, Franciaország
- Centre Hospitalier Alès-Cévennes
-
Kapcsolatba lépni:
- Jeanne-Claire SIX
- Telefonszám: 04 66 78 32 21
- E-mail: dr.six@ch-ales.fr
-
Béziers, Franciaország
- CH de Béziers
-
Kapcsolatba lépni:
- Samantha HUET
- Telefonszám: 04 67 35 76 07
- E-mail: samantha.huet@ch-beziers.fr
-
Mende, Franciaország
- CH de Mende
-
Kapcsolatba lépni:
- Agnès PREVOST-FEREY
- E-mail: agnesprevostferey@ch-mende.fr
-
Montpellier, Franciaország
- CHU de Montpellier
-
Kapcsolatba lépni:
- Philippe DERUELLE
- Telefonszám: 04 67 33 64 86
- E-mail: p-deruelle@chu-montpellier.fr
-
Nîmes, Franciaország, 30029
- CHU de Nîmes
-
Kapcsolatba lépni:
- Anissa Megzari
- Telefonszám: 04.66.68.42.36
- E-mail: drc@chu-nimes.fr
-
Sète, Franciaország
- CH de Sète
-
Kapcsolatba lépni:
- Angela MORARU
- Telefonszám: 04 67 46 57 57
- E-mail: amoraru@ch-bassindethau.fr
-
Toulouse, Franciaország
- CHU de Toulouse
-
Kapcsolatba lépni:
- Laure CONNAN
- Telefonszám: 5 67 77 12 33
- E-mail: connan.l@chu-toulouse.fr
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
Women with HG
|
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
|
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
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
|---|---|
|
Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum
Időkeret: Month 21
|
Month 21
|
|
Area under the curve for the PUQE score to diagnose hyperemesis gravidarum
Időkeret: Month 21
|
Month 21
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Area under the curve for the FRENCH HELP score to diagnose severe hyperemesis gravidarum
Időkeret: Month 21
|
Month 21
|
|
|
Area under the curve for the PUQE score to diagnose severe hyperemesis gravidarum
Időkeret: Month 21
|
Month 21
|
|
|
Discordance rate between FRENCH HELP and PUQE
Időkeret: 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
Időkeret: Month 21
|
percentage (%)
|
Month 21
|
|
Predictive values of FRENCH HELP score on miscarriage
Időkeret: Month 21
|
Classed as pregnancy loss before 15 weeks of gestation
|
Month 21
|
|
Predictive values of PUQE score on miscarriage
Időkeret: Month 21
|
Classed as pregnancy loss before 15 weeks of gestation
|
Month 21
|
|
Newborn small for gestational age
Időkeret: At birth (Max 9 months)
|
Classed as birth weight < 10th percentile
|
At birth (Max 9 months)
|
|
Preterm birth
Időkeret: At birth (Max 37 weeks)
|
Classed as delivery before 37 weeks of gestation
|
At birth (Max 37 weeks)
|
|
Gestational hypertension
Időkeret: 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
Időkeret: Before birth (max Month 9)
|
Classed as gestational hypertension and proteinuria >0.3 g/24 hours
|
Before birth (max Month 9)
|
|
Labor characteristics
Időkeret: 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
Időkeret: At birth (max month 9)
|
Yes/no
|
At birth (max month 9)
|
|
Birth weight
Időkeret: At birth (max 9 months)
|
grams
|
At birth (max 9 months)
|
|
newborn Apgar score < 7
Időkeret: At birth (max 9 months)
|
Yes/no
|
At birth (max 9 months)
|
|
Umbilical cord blood pH
Időkeret: At birth (max 9 months)
|
At birth (max 9 months)
|
|
|
Umbilical cord blood PCO2
Időkeret: At birth (max 9 months)
|
mmHg
|
At birth (max 9 months)
|
|
Umbilical cord blood PO2
Időkeret: At birth (max 9 months)
|
mmHg
|
At birth (max 9 months)
|
|
lactate levels in umbilical arterial blood
Időkeret: At birth (max 9 months)
|
mmol/L
|
At birth (max 9 months)
|
|
newborns transferred to a neonatal unit
Időkeret: At birth (max 9 months)
|
Yes/no
|
At birth (max 9 months)
|
|
presence of a congenital malformation
Időkeret: At birth (max 9 months)
|
Yes/no
|
At birth (max 9 months)
|
|
presence of depression
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Stephanie Huberlant, Centre Hospitalier Universitaire de Nîmes
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- AOI GCS/2025/S
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .