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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.

研究概览

地位

尚未招聘

条件

干预/治疗

其他：HELP score

研究类型

观察性的

注册 (估计的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Stephanie Huberlant
电话号码：04 66 68 32 20
邮箱：stephanie.huberlant@chu-nimes.fr

学习地点

法国
- - Alès、法国
    - Centre Hospitalier Alès-Cévennes
    - 接触：
      
      Jeanne-Claire SIX
      
      电话号码：04 66 78 32 21
      
      邮箱：dr.six@ch-ales.fr
  - Béziers、法国
    - CH de Béziers
    - 接触：
      
      Samantha HUET
      
      电话号码：04 67 35 76 07
      
      邮箱：samantha.huet@ch-beziers.fr
  - Mende、法国
    - CH de Mende
    - 接触：
      
      Agnès PREVOST-FEREY
      
      邮箱：agnesprevostferey@ch-mende.fr
  - Montpellier、法国
    - CHU de Montpellier
    - 接触：
      
      Philippe DERUELLE
      
      电话号码：04 67 33 64 86
      
      邮箱：p-deruelle@chu-montpellier.fr
  - Nîmes、法国、30029
    - CHU de Nîmes
    - 接触：
      
      Anissa Megzari
      
      电话号码：04.66.68.42.36
      
      邮箱：drc@chu-nimes.fr
  - Sète、法国
    - CH de Sète
    - 接触：
      
      Angela MORARU
      
      电话号码：04 67 46 57 57
      
      邮箱：amoraru@ch-bassindethau.fr
  - Toulouse、法国
    - CHU de Toulouse
    - 接触：
      
      Laure CONNAN
      
      电话号码：5 67 77 12 33
      
      邮箱：connan.l@chu-toulouse.fr

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列	干预/治疗
Women with HG	其他：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	其他：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

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Area under the curve for the FRENCH HELP score to diagnose hyperemesis gravidarum 大体时间：Month 21	Month 21
Area under the curve for the PUQE score to diagnose hyperemesis gravidarum 大体时间：Month 21	Month 21

次要结果测量

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centre Hospitalier Universitaire de Nīmes

调查人员

首席研究员：Stephanie Huberlant、Centre Hospitalier Universitaire de Nîmes

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2028年11月1日

研究完成 (估计的)

2028年11月1日

研究注册日期

首次提交

2026年8月11日

首先提交符合 QC 标准的

2026年8月11日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年8月1日

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

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

联系人和位置

学习联系方式

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

取样方法

研究人群

描述

学习计划

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (估计的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

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关键字

其他相关的 MeSH 术语

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