Clinical trial NCT06415084: Prevalence of Hyperemesis Gravidarum
Official title: Hyperemesis Gravidarum Prevalence : A Repeated Cross-sectional Population Based Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nausea and Vomiting
Keywords: Nausea vomiting
Pregnancy
Disease prevalence
Hyperemesis gravidarum
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Effik
name: Université d'Auvergne
name: AUDIPOG
First posted: 2024-05-16
Enrollment: 604
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women will be recruited for the study during their first-trimester ultrasound. They will be informed of the study by the sonographer, who will give them the link to access the first online study questionnaire. This questionnaire will enable tthe collect of the women's consent to particpate to the study, after online verification of eligibility criteria.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum)
timeFrame: First trimester of pregnancy (up to 13 weeks of gestation)
Secondary outcomes:
measure: Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum)
timeFrame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)
measure: Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum)
timeFrame: Third trimester of pregnancy (>= 28 weeks of gestation)
measure: Prevalence of uncomplicated pregnancy-related nausea and vomiting
timeFrame: First trimester of pregnancy (up to 13 weeks of gestation)
measure: Prevalence of uncomplicated pregnancy-related nausea and vomiting
timeFrame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)
measure: Prevalence of uncomplicated pregnancy-related nausea and vomiting
timeFrame: Third trimester of pregnancy (>= 28 weeks of gestation)
measure: Prevalence of hyperemesis gravidarum, with or without hospitalization
timeFrame: First trimester of pregnancy (up to 13 weeks of gestation)
measure: Prevalence of hyperemesis gravidarum, with or without hospitalization
timeFrame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)
measure: Prevalence of hyperemesis gravidarum, with or without hospitalization
timeFrame: Third trimester of pregnancy (>= 28 weeks of gestation)
measure: Prevalence of hyperemesis gravidarum with hospitalization
timeFrame: First trimester of pregnancy (up to 13 weeks of gestation)
measure: Prevalence of hyperemesis gravidarum with hospitalization
timeFrame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)
measure: Prevalence of hyperemesis gravidarum with hospitalization
timeFrame: Third trimester of pregnancy (>= 28 weeks of gestation)
measure: Distribution of mild, moderate and severe nausea and vomiting
timeFrame: First trimester of pregnancy (up to 13 weeks of gestation)
measure: Distribution of the modified-PUQE score
timeFrame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)
measure: Distribution of mild, moderate and severe nausea and vomiting
timeFrame: Third trimester of pregnancy (>= 28 weeks of gestation)
measure: Self-administered "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy" (NVP-QOL) questionnaire
timeFrame: First trimester of pregnancy (up to 13 weeks of gestation)
measure: Self-administered "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy" (NVP-QOL) questionnaire
timeFrame: Second trimester of pregnancy (between 14 an 27 weeks of gestation)
measure: Self-administered "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy" (NVP-QOL) questionnaire
timeFrame: Third trimester of pregnancy (>= 28 weeks of gestation)
measure: Self-administered "World Health Organization's Quality of Life-BREF " (WHOQOL-BREF) questionnaire
timeFrame: First trimester of pregnancy (up to 13 weeks of gestation)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Reseau de Santé en Périnatalité d'Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Françoise Vendittelli
role: PRINCIPAL_INVESTIGATOR
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