Prevalence of Hyperemesis Gravidarum
NCT06415084 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 604
Last updated 2025-05-06
Summary
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.
Conditions
- Nausea and Vomiting
Sponsors & Collaborators
-
Effik
collaborator INDUSTRY -
Université d'Auvergne
collaborator OTHER -
AUDIPOG
collaborator UNKNOWN -
University Hospital, Clermont-Ferrand
lead OTHER
Principal Investigators
-
Françoise Vendittelli · University Hospital, Clermont-Ferrand
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2026-07-31
- Completion
- 2026-12-31
Countries
- France
Study Locations
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