Clinical trial NCT06055192: Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022
Official title: Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Nausea
Vomiting of Pregnancy
Keywords: Nausea
Vomiting
Pregnancy
Lead sponsor: Effik SA
Sponsor class: OTHER
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2023-09-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 200 women during the weeks 18-22 of their pregnancy

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

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).

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* Subjects fulfilling one or more of the following exclusion criteria will not be included in the study:

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

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 185 days
Secondary outcomes:
measure: Secondary Outcome Measure
timeFrame: 185 days
measure: Secondary Outcome Measure
timeFrame: 185 days
measure: Secondary Outcome Measure
timeFrame: 185 days
measure: Secondary Outcome Measure
timeFrame: 185 days
measure: Secondary Outcome Measure
timeFrame: 185 days
measure: Secondary Outcome Measure
timeFrame: 185 days
measure: Secondary Outcome Measure
timeFrame: 185 days
measure: Secondary Outcome Measure
timeFrame: 185 days
measure: Secondary Outcome Measure
timeFrame: 185 days
measure: Secondary Outcome Measure
timeFrame: 185 days
measure: Secondary Outcome Measure
timeFrame: 185 days
Other outcomes:
Locations:
Study officials:
References:
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