NauseaNCT06055192
Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022
An observational study of Nausea and Vomiting of Pregnancy, run by Effik SA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nausea, Vomiting of Pregnancy
- What is being tested?
- Survey
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 women during the weeks 18-22 of their pregnancy
Who may be able to join
- Subjects will be eligible for inclusion if all the following criteria are respected:
- 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.
Who cannot join
- Subjects fulfilling one or more of the following exclusion criteria will not be included in the study:
- Twin pregnancy.
- Medically assisted procreation (MAP).
About this study
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
Read the detailed description
Nausea with or without vomiting (Nausea and Vomiting in Pregnancy - NVP) in early pregnancy (before 9 and up to 16 weeks of gestation) is very common (50-80%); these symptoms rarely persist throughout pregnancy (10-20%). Even if NVP aetiology remains unknown, the cause is most likely multifactorial NVP severity can be assessed with the validated, 24-hour Pregnancy-Unique Quantification of Emesis (PUQE-24) Scale.
Management and treatment of NVP focus on reducing symptoms, improving quality of life, preventing serious complications, and minimising foetal effects of maternal pharmacologic treatment. It is advised to follow dietary and lifestyle recommendations, followed by available alternative and pharmacological treatments.
Swissmedic has recently approved doxylamine as a drug for the treatment of NVP symptoms in combination with pyridoxine (Cariban®, Effik SA, Switzerland). Its efficacy and safety have been widely studied. A 2014 data re-analysis of a previous meta-analysis took into account a total of 139414 women in reports about the safety of antihistamines and 129108 in reports about the safety of doxylamine. In these studies, 23485 women were exposed to antihistamines and 14624 were exposed to doxylamine. Neither increased foetal risk for congenital malformations nor other adverse pregnancy outcomes were demonstrated. The safety of the drug is additionally supported by extensive international literature.
Moreover, a recent study showed that Cariban® behaves as a prolonged-release formulation, which correlates with rapid absorption and arising of the actives in the plasma, but also long-lasting and sustained bioavailability, especially when administered following the complete posology. These results would underlie its demonstrated efficacy to relieve nausea and vomiting of pregnancy (NVP) under clinical settings.
The exposure to doxylamine-pyridoxine in pregnancy (or to the combination of doxylamine and pyridoxine) is classified as safe, and its use is recommended as first-line therapy of nausea and vomiting in pregnancy by the American College of Obstetricians and Gynaecologists (ACOG) Guidelines, by the Society of Obstetricians and Gynecologists of Canada and organizations such as Mother to Baby (formerly known as Organization of Teratogen Information Services.
An epidemiological study, published in 2015, stated that the prevalence of nausea in Switzerland was 70,6%. It is to be noted that women who reported nausea also had a high burden of co-morbidity, especially heartburn and reflux symptoms and an association of NPV with symptoms of depression and sick leave was shown.
It is possible that the recent introduction of an association of doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg (Cariban®, Effik SA Switzerland) on the Swiss market and the recent publication of the SGGG Expert letter on NVP and hyperemesis gravidarum (1) could have had a substantial impact on the extent of this disturbance, the awareness of the therapists and the perception of the women.
In this context, a Survey will be carried out. A Survey is a procedure which, through a scientific method of detection (a questionnaire to be submitted to a representative sample of subjects related to the issue of the research) allows to collect, and subsequently to analyse, the data to study the relationships between different variables would yield significant scientific results.
The objectives of the study are: Evaluate the prevalence and burden that the symptoms of nausea and vomiting have in pregnant women in Switzerland.
The following outcomes will be evaluated:
- Demographic data (including ethnicity: Caucasian, African, Asian, or Other).
- NVP prevalence.
- Percentage of mild, medium, and severe cases based on PUQE-24.
- Percentage of answer allocation to NVP related questions.
- Onset for each symptom and its duration.
- Correlations between demographic data (age, first pregnancy status, multiparity, geographical origin, kinds of work and educational qualification) and the presence of symptoms and their severity.
- Correlation of the above-mentioned parameters with the use of non-pharmacological, pharmacological or both therapies.
- Analysis of drug therapies, of their correlation with the severity of the symptoms during pregnancy and with the possible outcomes of the same.
- Correlation between the severity of the symptoms and the consequences on the woman's personal life (family, work, etc.).
- Number of cases with hospitalization in relation to total and severity of symptoms (PUQE-24).
- Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire (weight of the new-born, gestational age at birth and any complications).
- Conditions
- Nausea, Vomiting of Pregnancy
- Being tested
- Survey
- Keywords
- Nausea, Vomiting, Pregnancy
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Evaluate the prevalence and burden that the symptoms of nausea and vomiting have in pregnant women in Switzerland
Measured: 185 days
Secondary outcomes (11)
Secondary Outcome Measure
demographic data (including ethnicity: Caucasian, African, Asian or Other).
Measured: 185 days
Secondary Outcome Measure
NVP prevalence
Measured: 185 days
Secondary Outcome Measure
Percentage of mild, medium, and severe cases based on PUQE-24.
Measured: 185 days
Secondary Outcome Measure
Percentage of answer allocation to NVP related questions
Measured: 185 days
Secondary Outcome Measure
Onset for each symptom and its duration
Measured: 185 days
Secondary Outcome Measure
Correlations between demographic data (age, first pregnancy status, multiparity, geographical origin, kinds of work and educational qualification) and the presence of symptoms and their severity.
Measured: 185 days
Secondary Outcome Measure
Correlation of the above-mentioned parameters with the use of non-pharmacological, pharmacological (e.g., Cariban®) or both therapies.
Measured: 185 days
Secondary Outcome Measure
Analysis of drug therapies, their correlation with the severity of the symptoms during pregnancy and with the possible outcomes of the same
Measured: 185 days
Secondary Outcome Measure
Correlation between the severity of the symptoms and the consequences on the woman's personal life (family, work, etc.).
Measured: 185 days
Secondary Outcome Measure
Number of cases with hospitalization in relation to total and severity of symptoms (PUQE-24).
Measured: 185 days
Secondary Outcome Measure
Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire (weight of the new-born, gestational age at birth and any complications).
Measured: 185 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Effik SA
- Sponsor type
- University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055192
- Sponsor's protocol ID
- OPEFF/0122/SU
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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
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/
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.
PubMed 39612885Ebrahimi 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.
PubMed 19941704Koren 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.
PubMed 12011891Koren 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.
PubMed 32811235Lee 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.
PubMed 21601782McParlin 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.
PubMed 27701665Nuangchamnong 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.
PubMed 24748822Madjunkova 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.
PubMed 24574047Gilboa 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.
PubMed 25307228Einarson 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.
PubMed 3229352McKeigue 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.
PubMed 7974252Koren 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.
PubMed 20843504
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022
- ClinicalTrials.gov ID
- NCT06055192
- Acronym / sponsor ID
- OPEFF/0122/SU
- Conditions
- Nausea, Vomiting of Pregnancy
- Keywords
- Nausea, Vomiting, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Effik SAUniversity, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Nausea with or without vomiting (Nausea and Vomiting in Pregnancy - NVP) in early pregnancy (before 9 and up to 16 weeks of gestation) is very common (50-80%); these symptoms rarely persist throughout pregnancy (10-20%). Even if NVP aetiology remains unknown, the cause is most likely multifactorial NVP severity can be assessed with the validated, 24-hour Pregnancy-Unique Quantification of Emesis (PUQE-24) Scale.
Management and treatment of NVP focus on reducing symptoms, improving quality of life, preventing serious complications, and minimising foetal effects of maternal pharmacologic treatment. It is advised to follow dietary and lifestyle recommendations, followed by available alternative and pharmacological treatments.
Swissmedic has recently approved doxylamine as a drug for the treatment of NVP symptoms in combination with pyridoxine (Cariban®, Effik SA, Switzerland). Its efficacy and safety have been widely studied. A 2014 data re-analysis of a previous meta-analysis took into account a total of 139414 women in reports about the safety of antihistamines and 129108 in reports about the safety of doxylamine. In these studies, 23485 women were exposed to antihistamines and 14624 were exposed to doxylamine. Neither increased foetal risk for congenital malformations nor other adverse pregnancy outcomes were demonstrated. The safety of the drug is additionally supported by extensive international literature.
Moreover, a recent study showed that Cariban® behaves as a prolonged-release formulation, which correlates with rapid absorption and arising of the actives in the plasma, but also long-lasting and sustained bioavailability, especially when administered following the complete posology. These results would underlie its demonstrated efficacy to relieve nausea and vomiting of pregnancy (NVP) under clinical settings.
The exposure to doxylamine-pyridoxine in pregnancy (or to the combination of doxylamine and pyridoxine) is classified as safe, and its use is recommended as first-line therapy of nausea and vomiting in pregnancy by the American College of Obstetricians and Gynaecologists (ACOG) Guidelines, by the Society of Obstetricians and Gynecologists of Canada and organizations such as Mother to Baby (formerly known as Organization of Teratogen Information Services.
An epidemiological study, published in 2015, stated that the prevalence of nausea in Switzerland was 70,6%. It is to be noted that women who reported nausea also had a high burden of co-morbidity, especially heartburn and reflux symptoms and an association of NPV with symptoms of depression and sick leave was shown.
It is possible that the recent introduction of an association of doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg (Cariban®, Effik SA Switzerland) on the Swiss market and the recent publication of the SGGG Expert letter on NVP and hyperemesis gravidarum (1) could have had a substantial impact on the extent of this disturbance, the awareness of the therapists and the perception of the women.
In this context, a Survey will be carried out. A Survey is a procedure which, through a scientific method of detection (a questionnaire to be submitted to a representative sample of subjects related to the issue of the research) allows to collect, and subsequently to analyse, the data to study the relationships between different variables would yield significant scientific results.
The objectives of the study are: Evaluate the prevalence and burden that the symptoms of nausea and vomiting have in pregnant women in Switzerland.
The following outcomes will be evaluated:
- Demographic data (including ethnicity: Caucasian, African, Asian, or Other).
- NVP prevalence.
- Percentage of mild, medium, and severe cases based on PUQE-24.
- Percentage of answer allocation to NVP related questions.
- Onset for each symptom and its duration.
- Correlations between demographic data (age, first pregnancy status, multiparity, geographical origin, kinds of work and educational qualification) and the presence of symptoms and their severity.
- Correlation of the above-mentioned parameters with the use of non-pharmacological, pharmacological or both therapies.
- Analysis of drug therapies, of their correlation with the severity of the symptoms during pregnancy and with the possible outcomes of the same.
- Correlation between the severity of the symptoms and the consequences on the woman's personal life (family, work, etc.).
- Number of cases with hospitalization in relation to total and severity of symptoms (PUQE-24).
- Correlation between symptoms in pregnancy and outcomes based on data from the post pregnancy questionnaire (weight of the new-born, gestational age at birth and any complications).
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 women during the weeks 18-22 of their pregnancy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Subjects fulfilling one or more of the following exclusion criteria will not be included in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySurvey | Other | – |
Primary outcome
Primary Outcome Measure
Time frame: 185 days
Evaluate the prevalence and burden that the symptoms of nausea and vomiting have in pregnant women in Switzerland
11 secondary outcomes
Secondary Outcome Measure
Time frame: 185 days
Secondary Outcome Measure
Time frame: 185 days
Secondary Outcome Measure
Time frame: 185 days
Secondary Outcome Measure
Time frame: 185 days
Secondary Outcome Measure
Time frame: 185 days
Secondary Outcome Measure
Time frame: 185 days
Secondary Outcome Measure
Time frame: 185 days
Secondary Outcome Measure
Time frame: 185 days
Secondary Outcome Measure
Time frame: 185 days
Secondary Outcome Measure
Time frame: 185 days
Secondary Outcome Measure
Time frame: 185 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- BackgroundSR 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
- Backgroundfedlex-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
- BackgroundWMA - 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: PubMed 39612885Martinez 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.
- Background: PubMed 19941704Ebrahimi 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.
- Background: PubMed 12011891Koren 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.
- Background: PubMed 32811235Koren 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.
- Background: PubMed 21601782Lee 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.
- Background: PubMed 27701665McParlin 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.
- Background: PubMed 24748822Nuangchamnong 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.
- Background: PubMed 24574047Madjunkova 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.
- Background: PubMed 25307228Gilboa 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.
- Individual participant dataSharing planned: No
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea and Vomiting of Pregnancy, run by Effik SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 185 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055192, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.