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

2026年8月11日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

観察的

入学 (推定)

300

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • フランス
      • Alès、フランス
        • Centre Hospitalier Alès-Cévennes
        • コンタクト：
      • Béziers、フランス
      • Mende、フランス
      • Montpellier、フランス
      • Nîmes、フランス、30029
        • CHU de Nîmes
        • コンタクト：
      • Sète、フランス
      • Toulouse、フランス

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Women with HG
他の：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
他の：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

この研究は何を測定していますか？

主要な結果の測定

結果測定
時間枠
Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum
時間枠：Month 21
Month 21
Area under the curve for the PUQE score to diagnose hyperemesis gravidarum
時間枠：Month 21
Month 21

二次結果の測定

結果測定
メジャーの説明
時間枠
Area under the curve for the FRENCH HELP score to diagnose severe hyperemesis gravidarum
時間枠：Month 21
Month 21
Area under the curve for the PUQE score to diagnose severe hyperemesis gravidarum
時間枠：Month 21
Month 21
Discordance rate between FRENCH HELP and PUQE
時間枠：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
時間枠：Month 21
percentage (%)
Month 21
Predictive values of FRENCH HELP score on miscarriage
時間枠：Month 21
Classed as pregnancy loss before 15 weeks of gestation
Month 21
Predictive values of PUQE score on miscarriage
時間枠：Month 21
Classed as pregnancy loss before 15 weeks of gestation
Month 21
Newborn small for gestational age
時間枠：At birth (Max 9 months)
Classed as birth weight < 10th percentile
At birth (Max 9 months)
Preterm birth
時間枠：At birth (Max 37 weeks)
Classed as delivery before 37 weeks of gestation
At birth (Max 37 weeks)
Gestational hypertension
時間枠：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
時間枠：Before birth (max Month 9)
Classed as gestational hypertension and proteinuria >0.3 g/24 hours
Before birth (max Month 9)
Labor characteristics
時間枠：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
時間枠：At birth (max month 9)
Yes/no
At birth (max month 9)
Birth weight
時間枠：At birth (max 9 months)
grams
At birth (max 9 months)
newborn Apgar score < 7
時間枠：At birth (max 9 months)
Yes/no
At birth (max 9 months)
Umbilical cord blood pH
時間枠：At birth (max 9 months)
At birth (max 9 months)
Umbilical cord blood PCO2
時間枠：At birth (max 9 months)
mmHg
At birth (max 9 months)
Umbilical cord blood PO2
時間枠：At birth (max 9 months)
mmHg
At birth (max 9 months)
lactate levels in umbilical arterial blood
時間枠：At birth (max 9 months)
mmol/L
At birth (max 9 months)
newborns transferred to a neonatal unit
時間枠：At birth (max 9 months)
Yes/no
At birth (max 9 months)
presence of a congenital malformation
時間枠：At birth (max 9 months)
Yes/no
At birth (max 9 months)
presence of depression
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Centre Hospitalier Universitaire de Nīmes

捜査官

  • 主任研究者：Stephanie Huberlant、Centre Hospitalier Universitaire de Nîmes

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2028年11月1日

研究の完了 (推定)

2028年11月1日

試験登録日

最初に提出

2026年8月11日

QC基準を満たした最初の提出物

2026年8月11日

最初の投稿 (実際)

2026年8月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月17日

QC基準を満たした最後の更新が送信されました

2026年8月11日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AOI GCS/2025/S

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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