Prevalence of Hyperemesis Gravidarum

NCT06415084 | Recruiting

• 1 other identifier: RNI 2024 VENDITTELLI
• Study Type: observational
• Target: 604
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea and Vomiting

Keywords

Nausea vomiting; Pregnancy; Disease prevalence; Hyperemesis gravidarum

Outcome Measures

Primary Outcomes (1)

• Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum)

  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.

  First trimester of pregnancy (up to 13 weeks of gestation)

Secondary Outcomes (18)

• Prevalence of pregnancy-related nausea and/or vomiting (uncomplicated or with hyperemesis gravidarum)

  Second trimester of pregnancy (between 14 an 27 weeks of gestation)

• 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

  First trimester of pregnancy (up to 13 weeks of gestation)

• Prevalence of uncomplicated pregnancy-related nausea and vomiting

  Second trimester of pregnancy (between 14 an 27 weeks of gestation)

• Prevalence of uncomplicated pregnancy-related nausea and vomiting

  Third trimester of pregnancy (>= 28 weeks of gestation)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only pregnant women are included in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Effik: collaborator
• Université d'Auvergne: collaborator
• AUDIPOG: collaborator

Study Sites (1)

Reseau de Santé en Périnatalité d'Auvergne

Clermont-Ferrand, France

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Dochez V, Dimet J, David-Gruselle A, Le Thuaut A, Ducarme G. Validation of specific questionnaires to assess nausea and vomiting of pregnancy in a French population. Int J Gynaecol Obstet. 2016 Sep;134(3):294-8. doi: 10.1016/j.ijgo.2016.01.023. Epub 2016 May 19.

  PMID: 27262942 BACKGROUND

• Baumann C, Erpelding ML, Regat S, Collin JF, Briancon S. The WHOQOL-BREF questionnaire: French adult population norms for the physical health, psychological health and social relationship dimensions. Rev Epidemiol Sante Publique. 2010 Feb;58(1):33-9. doi: 10.1016/j.respe.2009.10.009. Epub 2010 Jan 21.

  PMID: 20096515 BACKGROUND

MeSH Terms

Conditions

Nausea; Vomiting; Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Françoise Vendittelli

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)