AIMS OF THE STUDY: The prevalence of the use of valproate during pregnancy and by women of childbearing age in Switzerland is not known. We aimed to study the use of antiseizure drugs by these women in Switzerland, with a particular focus on valproate.

METHODS: We conducted a retrospective descriptive study using the healthcare claims database of the Swiss health insurance Helsana (2014–18). We established two separate study populations: (1) a cohort of pregnancies leading to a delivery, and (2) all women of childbearing age (15–45 years) who were insured with Helsana for at least one year during the study period. We identified the dispensation of valproate, lamotrigine, carbamazepine, levetiracetam, topiramate, pregabalin, gabapentin, phenobarbital, and phenytoin (1) between delivery and three months prior to the estimated date of the last menstrual period, and (2) by calendar year. We quantified exposure prevalence of each antiseizure drug as the number of women with ≥1 prescription fill per 10,000 (1) pregnancies, and (2) women by calendar year. Results were weighted for the demographic distribution of the Helsana population relative to the Swiss population.

RESULTS: We identified a weighted pregnancy population of 387,418 pregnancies, with a mean maternal age at delivery of 31.9 years (standard deviation 5.1). Lamotrigine was the most frequently dispensed antiseizure drug during pregnancy (20/10,000), followed by levetiracetam (11/10,000), and pregabalin (3.8/10,000). Valproate was dispensed to 1.9/10,000 women during pregnancy and to 1.3/10,000 women within 90 days prior to the last menstrual period but not during pregnancy. The weighted study population of women aged 15–45 years consisted of 2,781,151 women, of whom 74,080 (270/10,000) were exposed to ≥1 of the evaluated antiseizure drugs. Pregabalin was the most frequently dispensed antiseizure drug (64/10,000), followed by lamotrigine (46/10,000), topiramate (32/10,000), and valproate (25/10,000). The use of valproate decreased from 28/10,000 women in 2014 to 21/10,000 women in 2018.

CONCLUSIONS: The prevalence of exposure to valproate during pregnancy was comparable to Denmark and lower than in other European countries. Despite decreasing exposure prevalence, the use of valproate in women of childbearing age in Switzerland seems higher than the actual clinical need.

The issue of contraception and pregnancy tests among minor adolescent women participating in clinical trials, whether healthy or suffering from a disease, represents a challenging issue for paediatricians and researchers, given the potential harmful effect of various therapeutic procedures being tested. First, they need to gauge at what age or developmental stage they need to impose pregnancy tests and contraception. Second, if the adolescent denies any sexual activity, it may be ethically questionable to impose such procedures. Third, these professionals must deal with the issue of confidentiality, taking into account the fact that some adolescents engage in penetrative sexual intercourse without their parents or caregivers knowing. Fourth, in such cases, they must assess the extent to which a minor adolescent can be considered as competent (capable of making autonomous decisions) and deserves privacy and confidentiality. There is indeed a legal obligation for the provider to check that sexual experiences and intercourse take place within a safe relationship. Fifth, if the prescription of contraception is warranted, they have to decide who should assist the adolescent in choosing the method. Finally, with the occurrence of a positive pregnancy test, they may face the rare instance of a competent minor adolescent who refuses to inform her parents. This article has been developed by a group of experts under the auspices of swissethics, the Swiss Association of Research Ethics Committees and SwissPedNet, the umbrella organisation that coordinates the paediatric research in Switzerland. The paper reviews how to address practical and ethical questions regarding minor adolescents of childbearing potential enrolled in a clinical trial that may involve teratogenic medication and offers a series of concrete advice and tools for dealing with problematic situations.

Most paediatric protocols stipulate that adolescents included in clinical trials involving potentially teratogenic drugs should undergo pregnancy tests and use contraception. The circumstances in which such requirements are undertaken, however, has not been sufficiently addressed.

The recommendations presented in this article will assist researchers in assessing which circumstances apply when considering minor adolescents as individuals with childbearing potentials. It also offers concrete suggestions for tackling such situations.

PURPOSE: Vitamin D is primarily known for its role in bone health. However, it has a much more diverse role in the human metabolism. Specifically, deficiency of vitamin D has recently been studied for its possible role in adverse pregnancy outcomes such as preeclampsia, gestational diabetes and preterm birth. Vitamin D levels largely depend on exposure to the sun and are influenced by nutritional habits at only a minimal level. In Switzerland, it is estimated that 40–50% of the population is vitamin D deficient. No specific data on pregnant women is available. The recommendations of the Swiss Federal Commission for Nutrition include a supplement of 600 IU of vitamin D to all pregnant women, despite the lack of data for this population in Switzerland. The primary aim of this study was to determine the prevalence of vitamin D deficiency among the population of pregnant women receiving prenatal care and giving birth at our clinic. We assumed that the prevalence of vitamin D deficiency in pregnant women in Switzerland is significantly higher than what has been estimated. Therefore, the current recommendations for vitamin D supplementation in pregnant women may be insufficient to achieve appropriate vitamin D levels. Furthermore, we aimed to address the issue of the potential influence of vitamin D deficiency on adverse pregnancy outcomes.

METHODS: We performed a retrospective, observational cross-sectional study of 1382 pregnant women attending prenatal care at our department between 2012 and 2015. Serum 25-dihydroxycholecalciferol (25(OH)D) levels were determined in the first trimester, and the patient’s characteristics, the course of the pregnancy, any complications, the delivery and the neonatal outcome were analysed. The risk factors for vitamin D deficiency and its correlation with adverse pregnancy outcomes were assessed using a multivariate analysis.

RESULTS: The clear majority (73.23%) of the population studied were found to be vitamin D deficient, with serum levels of 25(OH)D <50 nmol/l. More importantly, severe vitamin D deficiency (25(OH)D levels below 25 nmol/l) was present in one third (34.2%) of all pregnant women. The mean 25(OH)D level was 36.72 ± 19.63 nmol/l. In the multivariate analysis, those with a high BMI and who belonged to ethnicities comprising people who are generally dark-skinned were found to be associated with lower 25(OH)D serum levels (p <0.0001). We detected a seasonal influence: the mean 25(OH)D level was significantly higher during the summer season (April–September) compared to the winter season (October–March) (p <0.0001). We found an association between low 25(OH)D serum level and gestational diabetes (p = 0.0116). Surprisingly, a low 25(OH)D level was also associated with decreased incidence of postpartum hemorrhage and placental retention (p = 0.02). We found no association between the 25(OH)D serum level and preeclampsia, preterm birth, postdate pregnancy, miscarriage, intrauterine growth restriction, bacterial vaginosis, mode of delivery, or neonatal birth weight and length.

CONCLUSION: We performed a retrospective analysis of serum 25(OH)D concentrations in pregnant Swiss women and found a mean serum 25(OH)D level of about 37 nmol/l and that one third of the overall study population had a serum 25(OH)D level below 25 nmol/l, and were thus seriously vitamin D deficient. Furthermore, the data demonstrate that vitamin D deficiency is associated with gestational diabetes. The current recommendations of vitamin D supplementation of 600 IU in pregnant women are therefore insufficient, and novel strategies, such as general screening for vitamin D deficiency, pre-conceptional timing of the supplementation and individually tailored dosing of vitamin D supplementation seem mandatory, potentially leading to improved maternal health and benefits to children’s long-term health in Switzerland and worldwide. (trial registration ClinicalTrial.gov. Identifier: NCT02904720)

In Switzerland, voluntary termination of pregnancy (VTP) can be performed in all public and private hospitals with an obstetrics/gynaecology department. For various reasons, many Italian women use the Swiss healthcare system, in particular in Canton Ticino, a border region adjacent to Italy in the southern part of Switzerland, when they want to have a VTP. In this study, we aimed to illustrate trends in the VTPs in the Canton Ticino between 2008 and 2015 and demonstrate differences between the Swiss women resident in Switzerland (SSR), foreign women resident in Switzerland (FSR) and foreign women resident abroad (FAR), focusing in particular on the Italian women as during this period there were legal changes in Italy. The number of VTPs was constant on a national level (10,924 in 2008, 10,255 in 2015); in contrast, since 2012 the number has progressively decreased (41%) in Ticino, mainly because of the significant reduction in VTPs in women resident in Italy (decrease of 75.7%). In addition, we wanted to evaluate the impact of the pre-VTP counselling at a family planning centre (FPC) on the VTP decision. The high number of pre-VTP consultations suggests that this service is appreciated and helpful. We observed an encouraging trend in changing the decision to have a VTP after the consultation at the FPC, where 12% of the pregnant women decided to continue the pregnancy. Because of its location, the Canton Ticino is an example how availability of certain drugs, methods and laws can influence the cross-border flow of the patients.

OBJECTIVE: Affected women and health professionals are still often unsure about how to react to exposures to potentially harmful agents during pregnancy. We wanted to find out which agents worry both pregnant women and professionals, under what circumstances the exposures take place, how they are currently dealt with and how serious they are.

METHODS: Making use of the archives of Tox Info Suisse, the foundation that provides poisons information in Switzerland both for members of the general public and for healthcare professionals, we set up an analysis of exposures to possibly harmful agents during pregnancy. Queries during pregnancy between 1995 and 2015 were analysed. Demographic information, exposure and agent characteristics as well as – in a subgroup of cases – the corresponding treatments were considered in the present descriptive, retrospective analysis.

RESULTS: Over the 21-year period, 2871 exposures during pregnancy were identified. The majority of the calls were made by members of the general public (2035, 70.9%; most often by the affected women themselves), followed by physicians (733, 25.5%). General public queries were mostly due to exposures connected with household chemicals (675/2035, 33.2%); those of physicians were most often due to medications (415/733, 56.6%). The majority of agent exposures occurred accidentally at home, at work, outdoors or at various other places (2297/2871, 80.0%). Less frequently, the exposures were intentional and had a suicidal, abusive, criminal or other character (471/2871, 16.4%). Of the 2871 calls, 905 cases with symptoms were recorded. Of the 1268 symptoms, 820 were mild (64.7%), 144 moderate (11.3%), 24 severe (1.9%, including 12 abortions) and 280 were not further specified (22.1%). In 1867 cases (65%), a total of 2331 measures were recommended by Tox Info Suisse, 1961 thereof to be carried out immediately. The two most common immediate measures were exposure interruption (412/1961, 21.0%) and forwarding to another institution (345/1961, 17.6%). In 70 cases, physicians’ follow-up reports could be analysed; paracetamol was the agent most frequently involved (15 cases), followed by mefenamic acid (9) and the household product sodium hypochlorite (9).

CONCLUSIONS: Tox Info Suisse recorded an average of 137 cases of agent exposure during pregnancy per year, mostly due to accidents with household products. Suicidal intentions played a role in a considerable number of exposures. Measures are needed to prevent accidental exposure of pregnant women to toxic substances and to support them in this exceptional life period.