Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06415084

Prevalence of Hyperemesis Gravidarum

Nausea and vomiting during pregnancy represent one of the most common symptoms of pregnancy, affecting 35 to 91% of women. Most often, the symptoms are mild, without impairment of quality of life and disappear at the end of the first trimester. More severe forms constitute hyperemesis gravidarum (HG) (hyperemesis gravidarum). In approximately 35% of women, nausea and vomiting during pregnancy are disabling, alter daily life and professional activity and negatively affect family relationships. For 0.3 to 3.6% of pregnancies, this vomiting is uncontrollable and constitutes the main cause of hospitalization in the first trimester of pregnancy.

Faced with the incomprehension and lack of knowledge of their illness, both in society and in the medical community, patient associations have been created in France to gain recognition for HG and raise awareness among caregivers and women about this illness and its consequences. Vomiting repeatedly for weeks, losing weight sometimes significantly, being weakened, no longer able to cope with daily life, family life and work, is what some women can experience while they are pregnant and that society tells them : "pregnancy is not an illness".

Although HG is common, its real prevalence is unknown, particularly in France, because there have been few studies involving small samples. A population study is desirable because it is likely that the prevalence of these pregnancy aches differs depending on the country. This subject is important because vomiting during pregnancy has an impact on women's quality of life and their desire to become pregnant again.

The main objective of this observation study is to evaluate the prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum), in the general population, in the first trimester of pregnancy.

The secondary objectives are:

* to assess the prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum), in the second and third trimesters of pregnancy, * to assess the prevalence of uncomplicated pregnancy-related nausea and/or vomiting in the three trimesters of pregnancy, * to evaluate the prevalence of hyperemesis gravidarum (with or without hospitalization) in the three trimesters of pregnancy, * to evaluate the prevalence of hyperemesis gravidarum requiring hospitalization in the three trimesters of pregnancy, * to evaluate the distribution of nausea and/or vomiting (mild, moderate and severe) according to the modified-PUQE score, in the three trimesters of pregnancy, * to evaluate the predictive factors for the occurrence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum) in the first trimester of pregnancy, * to assess health-related quality of life in the event of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum), in the three trimesters of pregnancy, * and to compare health-related quality of life between women with pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum) and those without, in the first trimester of pregnancy.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Nausea and Vomiting Female Urogenital Diseases and Pregnancy Complications Hyperemesis Gravidarum Morning Sickness Nausea Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Vomiting

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Reseau de Santé en Périnatalité d'Auvergne

Clermont-Ferrand, France

Location status: Recruiting

Location contact

Françoise Vendittelli, PhD

CONTACT

[email protected]

+33 04 73 75 01 07

About this study

Study design: A repeated population based cross sectional survey.

A woman can withdraw from the study early for the following reasons:

  • the woman's decision,
  • a major protocol deviation,
  • and loss to follow-up (a subject lost to follow-up is a participant who did not answer to all the surveys)

The study may be stopped temporarily or permanently for the following reasons:

  • Recruitment too low or nonexistent,
  • Decision of the sponsor and of the investigator-coordinator.

Methods of recruitment :

The inclusion of women will take place after one of the 1st trimester ultrasounds. They will have to complete, from their home, an online self-questionnaire including, among other things, the modified-PUQE score assessing the severity of nausea and vomiting during the first trimester of pregnancy. Women who have had an early ultrasound, before 10 weeks of amenorrhea (WA), will be re-interviewed at the start of the 2nd trimester via an online questionnaire.

Subsequently, women who responded in the 1st trimester and who present with hyperemesis gravidarum or uncomplicated pregnancy-related nausea and/or vomiting will be questioned, again, about the existence of nausea and vomiting just after the deadline for the 2nd trimester ultrasounds (between 20 WA+0 day and 25 WA+0 day) and 3rd trimester (between 30 WA+0 day and 35 WA+0 day), via an online self-questionnaire.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women having a monitored pregnancy in Auvergne,
  • Major,
  • Speaking French,
  • Socially insured,
  • Having given their agreement to participate in the study.

Exclusion criteria

  • Women refusing to participate in the study,
  • Not speaking French,
  • Major incapacitated persons.

Treatment and study plan

Primary outcomes

  1. Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum)

    Time frame: First trimester of pregnancy (up to 13 weeks of gestation)

    Prevalence of uncomplicated nausea and/or vomiting or with hyperemesis gravidarum. Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss < 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6. Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7.

Secondary outcomes

  1. Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum)

    Time frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)

    Prevalence of uncomplicated nausea and/or vomiting or with hyperemesis gravidarum. Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss < 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6. Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7.

  2. Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum)

    Time frame: Third trimester of pregnancy (>= 28 weeks of gestation)

    Prevalence of uncomplicated nausea and/or vomiting or with hyperemesis gravidarum. Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss < 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6. Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7.

  3. Prevalence of uncomplicated pregnancy-related nausea and vomiting

    Time frame: First trimester of pregnancy (up to 13 weeks of gestation)

    Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss < 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6.

  4. Prevalence of uncomplicated pregnancy-related nausea and vomiting

    Time frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)

    Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss < 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6.

  5. Prevalence of uncomplicated pregnancy-related nausea and vomiting

    Time frame: Third trimester of pregnancy (>= 28 weeks of gestation)

    Uncomplicated pregnancy-related nausea and vomiting is defined as pregnancy-related nausea and vomiting associated with: weight loss < 5%; without clinical signs of dehydration and; a modified-PUQE score ≤ 6.

  6. Prevalence of hyperemesis gravidarum, with or without hospitalization

    Time frame: First trimester of pregnancy (up to 13 weeks of gestation)

    Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7.

  7. Prevalence of hyperemesis gravidarum, with or without hospitalization

    Time frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)

    Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7.

  8. Prevalence of hyperemesis gravidarum, with or without hospitalization

    Time frame: Third trimester of pregnancy (>= 28 weeks of gestation)

    Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7.

  9. Prevalence of hyperemesis gravidarum with hospitalization

    Time frame: First trimester of pregnancy (up to 13 weeks of gestation)

    Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. The women are hospitalized.

  10. Prevalence of hyperemesis gravidarum with hospitalization

    Time frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)

    Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. The women are hospitalized.

  11. Prevalence of hyperemesis gravidarum with hospitalization

    Time frame: Third trimester of pregnancy (>= 28 weeks of gestation)

    Hyperemesis gravidarum is defined as pregnancy-related nausea and vomiting associated with at least one of the following signs: weight loss ≥ 5%; one or more clinical signs of dehydration; a modified-PUQE score ≥ 7. The women are hospitalized.

  12. Distribution of mild, moderate and severe nausea and vomiting

    Time frame: First trimester of pregnancy (up to 13 weeks of gestation)

    Distribution of nausea and vomiting according to the modified-PUQE score: mild (modified-PUQE score ≤ 6), moderate (modified-PUQE score ≥ 7 and ≤ 12) and severe (modified-PUQE score ≥ 13) vomiting.

  13. Distribution of the modified-PUQE score

    Time frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)

    Distribution of nausea and vomiting according to the modified-PUQE score: mild (modified-PUQE score ≤ 6), moderate (modified-PUQE score ≥ 7 and ≤ 12) and severe (modified-PUQE score ≥ 13) vomiting.

  14. Distribution of mild, moderate and severe nausea and vomiting

    Time frame: Third trimester of pregnancy (>= 28 weeks of gestation)

    Distribution of nausea and vomiting according to the modified-PUQE score: mild (modified-PUQE score ≤ 6), moderate (modified-PUQE score ≥ 7 and ≤ 12) and severe (modified-PUQE score ≥ 13) vomiting.

  15. Self-administered "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy" (NVP-QOL) questionnaire

    Time frame: First trimester of pregnancy (up to 13 weeks of gestation)

    The NVP-QOL questionnaire measures health-related quality of life in the last week and contains 30 items covering 4 general domains: physical symptoms and/or aggravating factors (9 items), fatigue (4 items), emotions (7 items), and limitations (10 items). Each item is measured using a 7-point Likert scale from 1 ("none of the time") to 7 ("all the time"). A total score is obtained by summing the scores of each of the 30 items (with reversed score for item 20), and ranges between 30 (corresponding to good QOL) and 210 (corresponding to poor QOL).

  16. Self-administered "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy" (NVP-QOL) questionnaire

    Time frame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)

    The NVP-QOL questionnaire measures health-related quality of life in the last week and contains 30 items covering 4 general domains: physical symptoms and/or aggravating factors (9 items), fatigue (4 items), emotions (7 items), and limitations (10 items). Each item is measured using a 7-point Likert scale from 1 ("none of the time") to 7 ("all the time"). A total score is obtained by summing the scores of each of the 30 items (with reversed score for item 20), and ranges between 30 (corresponding to good quality of life) and 210 (corresponding to poor quality of life).

  17. Self-administered "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy" (NVP-QOL) questionnaire

    Time frame: Third trimester of pregnancy (>= 28 weeks of gestation)

    The NVP-QOL questionnaire measures health-related quality of life in the last week and contains 30 items covering 4 general domains: physical symptoms and/or aggravating factors (9 items), fatigue (4 items), emotions (7 items), and limitations (10 items). Each item is measured using a 7-point Likert scale from 1 ("none of the time") to 7 ("all the time"). A total score is obtained by summing the scores of each of the 30 items (with reversed score for item 20), and ranges between 30 (corresponding to good quality of life) and 210 (corresponding to poor quality of life).

  18. Self-administered "World Health Organization's Quality of Life-BREF " (WHOQOL-BREF) questionnaire

    Time frame: First trimester of pregnancy (up to 13 weeks of gestation)

    The WHOQOL-BREF questionnaire measures generic health-related quality of life in the last two weeks and includes a subset of 26 items. Information from all 26 items is used to calculate scores of four subscales: Physical health, Psychological health, Social relationships, and Environment. Subscales scores range from 0 to 100, with higher scores indicating better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • AUDIPOG
  • Effik
  • Université d'Auvergne

Registry information

Official study title

Hyperemesis Gravidarum Prevalence : A Repeated Cross-sectional Population Based Study

Acronym: PHyperEG1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 16, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.