Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415084
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-07
Brief Title:
Prevalence of Hyperemesis Gravidarum
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Hyperemesis Gravidarum Prevalence a Repeated Cross-sectional Population Based Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHyperEG1
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 03 to 36 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 womens 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 andor 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 andor vomiting uncomplicated or with hyperemesis gravidarum in the second and third trimesters of pregnancy
to assess the prevalence of uncomplicated pregnancy-related nausea andor 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 andor 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 andor 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 andor 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 andor vomiting uncomplicated or with hyperemesis gravidarum and those without 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 womens 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 andor 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 andor vomiting uncomplicated or with hyperemesis gravidarum in the second and third trimesters of pregnancy
to assess the prevalence of uncomplicated pregnancy-related nausea andor 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 andor 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 andor 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 andor 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 andor 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 womans 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 andor vomiting will be questioned again about the existence of nausea and vomiting just after the deadline for the 2nd trimester ultrasounds between 20 WA0 day and 25 WA0 day and 3rd trimester between 30 WA0 day and 35 WA0 day via an online self-questionnaire
A woman can withdraw from the study early for the following reasons
the womans 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 andor vomiting will be questioned again about the existence of nausea and vomiting just after the deadline for the 2nd trimester ultrasounds between 20 WA0 day and 25 WA0 day and 3rd trimester between 30 WA0 day and 35 WA0 day via an online self-questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None