Prevalence of Hyperemesis Gravidarum

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum) [Срок оценки: First trimester of pregnancy (up to 13 weeks of gestation)]

Вторичные конечные точки (12)

• Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum) [Срок оценки: Second trimester of pregnancy (between 14 an 27 weeks of gestation)]
• Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum) [Срок оценки: Third trimester of pregnancy (>= 28 weeks of gestation)]
• Prevalence of uncomplicated pregnancy-related nausea and vomiting [Срок оценки: First trimester of pregnancy (up to 13 weeks of gestation)]
• Prevalence of uncomplicated pregnancy-related nausea and vomiting [Срок оценки: Second trimester of pregnancy (between 14 an 27 weeks of gestation)]
• Prevalence of uncomplicated pregnancy-related nausea and vomiting [Срок оценки: Third trimester of pregnancy (>= 28 weeks of gestation)]
• Prevalence of hyperemesis gravidarum, with or without hospitalization [Срок оценки: First trimester of pregnancy (up to 13 weeks of gestation)]
• Prevalence of hyperemesis gravidarum, with or without hospitalization [Срок оценки: Second trimester of pregnancy (between 14 an 27 weeks of gestation)]
• Prevalence of hyperemesis gravidarum, with or without hospitalization [Срок оценки: Third trimester of pregnancy (>= 28 weeks of gestation)]
• Prevalence of hyperemesis gravidarum with hospitalization [Срок оценки: First trimester of pregnancy (up to 13 weeks of gestation)]
• Prevalence of hyperemesis gravidarum with hospitalization [Срок оценки: Second trimester of pregnancy (between 14 an 27 weeks of gestation)]
• Prevalence of hyperemesis gravidarum with hospitalization [Срок оценки: Third trimester of pregnancy (>= 28 weeks of gestation)]
• Distribution of mild, moderate and severe nausea and vomiting [Срок оценки: First trimester of pregnancy (up to 13 weeks of gestation)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 1 центр

• Reseau de Santé en Périnatalité d'Auvergne — Clermont-Ferrand

Публикации

• Gadsby R, Barnie-Adshead AM, Jagger C. A prospective study of nausea and vomiting during pregnancy. Br J Gen Pract. 1993 Jun;43(371):245-8. PMID 8373648
• Einarson TR, Piwko C, Koren G. Quantifying the global rates of nausea and vomiting of pregnancy: a meta analysis. J Popul Ther Clin Pharmacol. 2013;20(2):e171-83. Epub 2013 Jul 13. PMID 23863575
• Attard CL, Kohli MA, Coleman S, Bradley C, Hux M, Atanackovic G, Torrance GW. The burden of illness of severe nausea and vomiting of pregnancy in the United States. Am J Obstet Gynecol. 2002 May;186(5 Suppl Understanding):S220-7. doi: 10.1067/mob.2002.122605. PMID 12011890
• Mazzotta P, Stewart D, Atanackovic G, Koren G, Magee LA. Psychosocial morbidity among women with nausea and vomiting of pregnancy: prevalence and association with anti-emetic therapy. J Psychosom Obstet Gynaecol. 2000 Sep;21(3):129-36. doi: 10.3109/01674820009075620. PMID 11076334
• Eliakim R, Abulafia O, Sherer DM. Hyperemesis gravidarum: a current review. Am J Perinatol. 2000;17(4):207-18. doi: 10.1055/s-2000-9424. PMID 11041443
• Heitmann K, Nordeng H, Havnen GC, Solheimsnes A, Holst L. The burden of nausea and vomiting during pregnancy: severe impacts on quality of life, daily life functioning and willingness to become pregnant again - results from a cross-sectional study. BMC Pregnancy Childbirth. 2017 Feb 28;17(1):75. doi: 10.1186/s12884-017-1249-0. PMID 28241811
• Lacasse A, Rey E, Ferreira E, Morin C, Berard A. Validity of a modified Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) scoring index to assess severity of nausea and vomiting of pregnancy. Am J Obstet Gynecol. 2008 Jan;198(1):71.e1-7. doi: 10.1016/j.ajog.2007.05.051. PMID 18166311
• Lacasse A, Berard A. Validation of the nausea and vomiting of pregnancy specific health related quality of life questionnaire. Health Qual Life Outcomes. 2008 May 9;6:32. doi: 10.1186/1477-7525-6-32. PMID 18471301

Идентификаторы

NCT: NCT06415084 · RNI 2024 VENDITTELLI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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