An observational study in Hyperemesis Gravidarum and Nausea and Vomiting of Pregnancy, sponsored by Centre Hospitalier Universitaire de Nīmes. Not yet recruiting at 7 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational
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.
40 studies on the registry are indexed under Hyperemesis Gravidarum; 6 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 15 observational studies indexed under Hyperemesis Gravidarum.
Browse Hyperemesis Gravidarum studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women with nausea or vomiting that began before 16 weeks of gestation with no other identifiable cause
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: HELP score
Other: 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
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
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
Time frame: At birth (max 9 months)
newborn Apgar score < 7
Yes/no
Time frame: At birth (max 9 months)
Umbilical cord blood pH
Time frame: At birth (max 9 months)
Umbilical cord blood PCO2
mmHg
Time frame: At birth (max 9 months)
Umbilical cord blood PO2
mmHg
Time frame: At birth (max 9 months)
lactate levels in umbilical arterial blood
mmol/L
Time frame: At birth (max 9 months)
newborns transferred to a neonatal unit
Yes/no
Time frame: At birth (max 9 months)
presence of a congenital malformation
Yes/no
Time frame: At birth (max 9 months)
presence of depression
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.
Time frame: Month 9
Convergent validity of FRENCH HELP against PUQE score
PUQE score - 3 questions regarding nausea, vomiting, and retching, scored from 1 to 15, where score is ≥ 13 is classified as severe.
Time frame: Month 21
Convergent validity of FRENCH HELP against WHOQOL quality-of-life score
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").
Time frame: Month 21
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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