Hyperemesis Gravidarum Prevalence : A Repeated Cross-sectional Population Based Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 604
- Locations
- 1
- Primary Endpoint
- Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women having a monitored pregnancy in Auvergne,
- •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.
Outcomes
Primary Outcomes
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
- Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum)(Third trimester of pregnancy (>= 28 weeks of gestation))
- Prevalence of uncomplicated pregnancy-related nausea and vomiting(Third trimester of pregnancy (>= 28 weeks of gestation))
- Prevalence of hyperemesis gravidarum, with or without hospitalization(Third trimester of pregnancy (>= 28 weeks of gestation))
- Prevalence of hyperemesis gravidarum with hospitalization(Third trimester of pregnancy (>= 28 weeks of gestation))
- Distribution of mild, moderate and severe nausea and vomiting(Third trimester of pregnancy (>= 28 weeks of gestation))
- Distribution of the modified-PUQE score(Second trimester of pregnancy (between 14 an 27 weeks of gestation))
- Self-administered "Health-Related Quality of Life for Nausea and Vomiting of Pregnancy" (NVP-QOL) questionnaire(Third trimester of pregnancy (>= 28 weeks of gestation))
- Self-administered "World Health Organization's Quality of Life-BREF " (WHOQOL-BREF) questionnaire(First trimester of pregnancy (up to 13 weeks of gestation))