NCT06055192

Brief Summary

The latest data on the prevalence of nausea in pregnancy in Switzerland is dated 2015 but has been hypothesised that the recent introduction on the market of new drugs against this symptom could modify its epidemiology. For this reason, we have planned the present survey, calculating an adequate sample size of Swiss pregnant women (the population of interest) and, according to a cross-sectional design, planning the collection of response variables with the aim of estimating the prevalence of burden and nausea and vomiting in pregnancy

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

September 20, 2023

Last Update Submit

September 25, 2023

Conditions

Keywords

NauseaVomitingPregnancy

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    Evaluate the prevalence and burden that the symptoms of nausea and vomiting have in pregnant women in Switzerland

    185 days

Secondary Outcomes (11)

  • Secondary Outcome Measure

    185 days

  • Secondary Outcome Measure

    185 days

  • Secondary Outcome Measure

    185 days

  • Secondary Outcome Measure

    185 days

  • Secondary Outcome Measure

    185 days

  • +6 more secondary outcomes

Interventions

SurveyOTHER

Survey

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Details200 women during the weeks 18-22 of their pregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

200 women during the weeks 18-22 of their pregnancy

You may qualify if:

  • Women aged ≥ 18 years.
  • Women in physiological pregnancy and between the 18th and 22nd week of pregnancy (at time of morphological ultrasound).
  • Women able to communicate adequately with the Investigator and able to read, understand and provide the answers required by the questionnaires in one of the languages in which they will be provided (Italian, German, French or English).
  • Women able to understand and who can provide valid informed consent to the Survey.

You may not qualify if:

  • Twin pregnancy.
  • Medically assisted procreation (MAP).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (42)

  • SR 810.301 - Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO) [Internet]. [cited 2022 Jun 13]. Available from: https://www.fedlex.admin.ch/eli/cc/2013/642/en

    BACKGROUND
  • fedlex-data-admin-ch-eli-cc-2013-643-20140101-en-pdf-a.pdf [Internet]. [cited 2022 Jun 13]. Available from: https://fedlex.data.admin.ch/filestore/fedlex.data.admin.ch/eli/cc/2013/643/20140101/en/pdf-a/fedlex-data-admin-ch-eli-cc-2013-643-20140101-en-pdf-a.pdf

    BACKGROUND
  • WMA - The World Medical Association-WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects [Internet]. [cited 2022 Jun 13]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

    BACKGROUND
  • Martinez de Tejada B, Vonzun L, Von Mandach DU, Burch A, Yaron M, Hodel M, Surbek D, Hoesli I. Nausea and vomiting of pregnancy, hyperemesis gravidarum. Eur J Obstet Gynecol Reprod Biol. 2025 Jan;304:115-120. doi: 10.1016/j.ejogrb.2024.11.006. Epub 2024 Nov 5. No abstract available.

    PMID: 39612885BACKGROUND
  • Ebrahimi N, Maltepe C, Bournissen FG, Koren G. Nausea and vomiting of pregnancy: using the 24-hour Pregnancy-Unique Quantification of Emesis (PUQE-24) scale. J Obstet Gynaecol Can. 2009 Sep;31(9):803-807. doi: 10.1016/S1701-2163(16)34298-0.

    PMID: 19941704BACKGROUND
  • Koren G, Boskovic R, Hard M, Maltepe C, Navioz Y, Einarson A. Motherisk-PUQE (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy. Am J Obstet Gynecol. 2002 May;186(5 Suppl Understanding):S228-31. doi: 10.1067/mob.2002.123054.

    PMID: 12011891BACKGROUND
  • Koren G, Cohen R. Measuring the severity of nausea and vomiting of pregnancy; a 20-year perspective on the use of the pregnancy-unique quantification of emesis (PUQE). J Obstet Gynaecol. 2021 Apr;41(3):335-339. doi: 10.1080/01443615.2020.1787968. Epub 2020 Aug 19.

    PMID: 32811235BACKGROUND
  • Lee NM, Saha S. Nausea and vomiting of pregnancy. Gastroenterol Clin North Am. 2011 Jun;40(2):309-34, vii. doi: 10.1016/j.gtc.2011.03.009.

    PMID: 21601782BACKGROUND
  • McParlin C, O'Donnell A, Robson SC, Beyer F, Moloney E, Bryant A, Bradley J, Muirhead CR, Nelson-Piercy C, Newbury-Birch D, Norman J, Shaw C, Simpson E, Swallow B, Yates L, Vale L. Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy: A Systematic Review. JAMA. 2016 Oct 4;316(13):1392-1401. doi: 10.1001/jama.2016.14337.

    PMID: 27701665BACKGROUND
  • Nuangchamnong N, Niebyl J. Doxylamine succinate-pyridoxine hydrochloride (Diclegis) for the management of nausea and vomiting in pregnancy: an overview. Int J Womens Health. 2014 Apr 12;6:401-9. doi: 10.2147/IJWH.S46653. eCollection 2014.

    PMID: 24748822BACKGROUND
  • Madjunkova S, Maltepe C, Koren G. The delayed-release combination of doxylamine and pyridoxine (Diclegis(R)/Diclectin (R)) for the treatment of nausea and vomiting of pregnancy. Paediatr Drugs. 2014 Jun;16(3):199-211. doi: 10.1007/s40272-014-0065-5.

    PMID: 24574047BACKGROUND
  • Gilboa SM, Ailes EC, Rai RP, Anderson JA, Honein MA. Antihistamines and birth defects: a systematic review of the literature. Expert Opin Drug Saf. 2014 Dec;13(12):1667-98. doi: 10.1517/14740338.2014.970164. Epub 2014 Oct 11.

    PMID: 25307228BACKGROUND
  • Einarson TR, Leeder JS, Koren G. A method for meta-analysis of epidemiological studies. Drug Intell Clin Pharm. 1988 Oct;22(10):813-24. doi: 10.1177/106002808802201021.

    PMID: 3229352BACKGROUND
  • McKeigue PM, Lamm SH, Linn S, Kutcher JS. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology. 1994 Jul;50(1):27-37. doi: 10.1002/tera.1420500105.

    PMID: 7974252BACKGROUND
  • Koren G, Clark S, Hankins GD, Caritis SN, Miodovnik M, Umans JG, Mattison DR. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J Obstet Gynecol. 2010 Dec;203(6):571.e1-7. doi: 10.1016/j.ajog.2010.07.030. Epub 2010 Sep 16.

    PMID: 20843504BACKGROUND
  • Chin JW, Gregor S, Persaud N. Re-analysis of safety data supporting doxylamine use for nausea and vomiting of pregnancy. Am J Perinatol. 2014 Sep;31(8):701-10. doi: 10.1055/s-0033-1358772. Epub 2013 Dec 9.

    PMID: 24323370BACKGROUND
  • Seto A, Einarson T, Koren G. Pregnancy outcome following first trimester exposure to antihistamines: meta-analysis. Am J Perinatol. 1997 Mar;14(3):119-24. doi: 10.1055/s-2007-994110.

    PMID: 9259911BACKGROUND
  • Lee J, Einarson A, Gallo M, Okotore B, Koren G. Longitudinal change in the treatment of nausea and vomiting of pregnancy in Ontario. Can J Clin Pharmacol. 2000 Winter;7(4):205-8.

    PMID: 11118967BACKGROUND
  • Persaud N, Chin J, Walker M. Should doxylamine-pyridoxine be used for nausea and vomiting of pregnancy? J Obstet Gynaecol Can. 2014 Apr;36(4):343-348. doi: 10.1016/S1701-2163(15)30611-3.

    PMID: 24798673BACKGROUND
  • Smolina K, Hanley GE, Mintzes B, Oberlander TF, Morgan S. Trends and Determinants of Prescription Drug Use during Pregnancy and Postpartum in British Columbia, 2002-2011: A Population-Based Cohort Study. PLoS One. 2015 May 26;10(5):e0128312. doi: 10.1371/journal.pone.0128312. eCollection 2015.

    PMID: 26011706BACKGROUND
  • Koren G. Safety considerations surrounding use of treatment options for nausea and vomiting in pregnancy. Expert Opin Drug Saf. 2017 Nov;16(11):1227-1234. doi: 10.1080/14740338.2017.1361403. Epub 2017 Aug 9.

    PMID: 28749713BACKGROUND
  • Fejzo MS, Trovik J, Grooten IJ, Sridharan K, Roseboom TJ, Vikanes A, Painter RC, Mullin PM. Nausea and vomiting of pregnancy and hyperemesis gravidarum. Nat Rev Dis Primers. 2019 Sep 12;5(1):62. doi: 10.1038/s41572-019-0110-3.

    PMID: 31515515BACKGROUND
  • Doxylamine/pyridoxine for nausea and vomiting in pregnancy. Drug Ther Bull. 2019 Mar;57(3):38-41. doi: 10.1136/dtb.2018.000053. Epub 2019 Jan 31. No abstract available.

    PMID: 30705026BACKGROUND
  • Brott NR, Reddivari AKR. Doxylamine. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 [cited 2023 Jun 22]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK551646/

    BACKGROUND
  • Biffi A, Rea F, Locatelli A, Cetin I, Filippelli A, Corrao G. Misleading meta-analyses of observational studies may generate unjustified alarms: The case of medications for nausea and vomiting in pregnancy. Pharmacol Res. 2021 Jan;163:105229. doi: 10.1016/j.phrs.2020.105229. Epub 2020 Oct 5.

    PMID: 33031909BACKGROUND
  • Berard A, Sheehy O, Gorgui J, Zhao JP, Soares de Moura C, Bernatsky S. New evidence for concern over the risk of birth defects from medications for nausea and vomitting of pregnancy. J Clin Epidemiol. 2019 Dec;116:39-48. doi: 10.1016/j.jclinepi.2019.07.014. Epub 2019 Jul 26.

    PMID: 31352006BACKGROUND
  • Brent RL. Bendectin: review of the medical literature of a comprehensively studied human nonteratogen and the most prevalent tortogen-litigen. Reprod Toxicol. 1995 Jul-Aug;9(4):337-49. doi: 10.1016/0890-6238(95)00020-b.

    PMID: 7496090BACKGROUND
  • Neutel CI, Johansen HL. Measuring drug effectiveness by default: the case of Bendectin. Can J Public Health. 1995 Jan-Feb;86(1):66-70.

    PMID: 7728721BACKGROUND
  • Saz-Leal P, Zamorano-Dominguez L, Frias J, Guerra P, Saura-Valls M, Roca-Juanes R, Nebot-Troyano J, Garcia-Aguilar E, Vilchez T, Urso K. Bioavailability of Cariban(R) Capsules: A Modified-Release Fixed-Dose Combination of Doxylamine and Pyridoxine to Relieve Nausea and Vomiting During Pregnancy. Drugs R D. 2023 Jun;23(2):185-195. doi: 10.1007/s40268-023-00425-7. Epub 2023 Jun 15.

    PMID: 37318714BACKGROUND
  • London V, Grube S, Sherer DM, Abulafia O. Hyperemesis Gravidarum: A Review of Recent Literature. Pharmacology. 2017;100(3-4):161-171. doi: 10.1159/000477853. Epub 2017 Jun 23.

    PMID: 28641304BACKGROUND
  • Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 189: Nausea And Vomiting Of Pregnancy. Obstet Gynecol. 2018 Jan;131(1):e15-e30. doi: 10.1097/AOG.0000000000002456.

    PMID: 29266076BACKGROUND
  • APGO. APGO. Nausea and vomiting of pregnancy. APGO Educational series on women's health issues. Boston: Jespersen & Associates, LLC; 2013. 2013.

    BACKGROUND
  • Arsenault MY, Lane CA, MacKinnon CJ, Bartellas E, Cargill YM, Klein MC, Martel MJ, Sprague AE, Wilson AK. The management of nausea and vomiting of pregnancy. J Obstet Gynaecol Can. 2002 Oct;24(10):817-31; quiz 832-3. English, French.

    PMID: 12405123BACKGROUND
  • Nausea and Vomiting of Pregnancy (NVP). 2022;

    BACKGROUND
  • Madjunkova S, Maltepe C, Koren G. The Leading Concerns of American Women with Nausea and Vomiting of Pregnancy Calling Motherisk NVP Helpline. Obstet Gynecol Int. 2013;2013:752980. doi: 10.1155/2013/752980. Epub 2013 Apr 15.

    PMID: 23690784BACKGROUND
  • Heitmann K, Solheimsnes A, Havnen GC, Nordeng H, Holst L. Treatment of nausea and vomiting during pregnancy -a cross-sectional study among 712 Norwegian women. Eur J Clin Pharmacol. 2016 May;72(5):593-604. doi: 10.1007/s00228-016-2012-6. Epub 2016 Jan 27.

    PMID: 26815908BACKGROUND
  • Heitmann K, Holst L, Lupattelli A, Maltepe C, Nordeng H. Treatment of nausea in pregnancy: a cross-sectional multinational web-based study of pregnant women and new mothers. BMC Pregnancy Childbirth. 2015 Dec 1;15:321. doi: 10.1186/s12884-015-0746-2.

    PMID: 26628289BACKGROUND
  • 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: 28241811BACKGROUND
  • Rubenfeld GD. Surveys: an introduction. Respir Care. 2004 Oct;49(10):1181-5.

    PMID: 15447800BACKGROUND
  • Safdar N, Abbo LM, Knobloch MJ, Seo SK. Research Methods in Healthcare Epidemiology: Survey and Qualitative Research. Infect Control Hosp Epidemiol. 2016 Nov;37(11):1272-1277. doi: 10.1017/ice.2016.171. Epub 2016 Aug 12.

    PMID: 27514583BACKGROUND
  • von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008.

    PMID: 18313558BACKGROUND
  • Office FS. Births [Internet]. [cited 2022 Jun 14]. Available from: https://www.bfs.admin.ch/bfs/en/home/statistiken/bevoelkerung/geburten-todesfaelle/geburten.html

    BACKGROUND

MeSH Terms

Conditions

NauseaVomiting

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 26, 2023

Study Start

September 1, 2023

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share