TDon’t worry, this is not a “no vax” article. And it would be too. Pregnancy is perhaps the most delicate moment in a woman’s life. The body changes so much that a new structure is formed (the placenta) and, above all, a new life is born (which then cries all night, but when it smiles…). For this reason, pregnancy must be protected and protected in the best possible way. That’s why i vaccines that are proposed in the nine months are more than safe. And even medicines, if prescribed by a specialist, can be taken with confidence. So where is the news? He has just left a study, “Advance”That analyze thousands of data obtained, very anonymously, from women who have given birth in recent years. Or expecting a baby. It is a “real world evidence” research, i.e. one that can only be done after clinical trials, to reinforce the results or add details to the results already obtained.
It starts with “administrative” data
“When a drug or vaccine is tested, in most cases clinical trials are conducted on men, adults, generally healthy,” explains Professor Alfredo Vannacci, Professor of Pharmacology and Toxicology at the Department of Neurosciences, Pharmaceuticals and Child Health Area, of the University of Florence. “It’s pretty obvious why they are few pregnant women participate in clinical trials. A great attention to the safety of mother and child limits the number of participants to the bare minimum. So most of the research in this field is done with data obtained from a selection of patients, not on the reality of the whole population» clarifies Vannacci. “Advance”, on the other hand, looks retrospectively at which vaccines women received during their pregnancy. How was their health condition, before and after the injection, and what kind of effects they had in the nine months. Or even after giving birth.
Privacy is fully guaranteed
“They analyze each other administrative data only, without ever identifying the person, but obtaining information from medical records, prescriptions, hospitalizations and other health evidence present in the databases of the Local Health Authority, the Region and the major Tuscan hospitals» explains Professor Vannacci, who is also the founder of the university spin-off Dynamedics. “For respect the privacy of every womanwho is still pregnant or who has given birth a few years ago, a code is assigned which then “self-destructs”, so that no one can trace who corresponds to a specific medical information”.
A very hi-tech project
The IT part of the research will be dealt with by, Spindoxa leading company in digital transformation, which will develop the App for managing the collected data and which, at the end of the project, will create a web portal to make the results accessible to all achieved. The project will also be coordinated through the Perinatal Research Laboratory (PeaRL) of the Ciao Lapo Foundation for perinatal health, also founded by Professor Vannacci.
Professor Alfredo Vannacci of the Department of Neuroscience, Drugs and Child Health Area (Neurofarba) is responsible for the “Adavance” study.
The effects of these vaccines will be analysed
During pregnancy, the recommended vaccinations, i.e. those that must be done for the good of the mother and the child, are: diphtheria, tetanus, whooping cough and flu. «If the first three have entered the common sense and almost all mothers do them, the flu shot is still viewed with a lot of skepticism. We think that the flu is not a serious disease and therefore we do not protect ourselves,” he explains Vannacci. «Catching the flu during pregnancy, on the other hand, can create serious problems for both the mother and the fetus. Some strains of the viruses that cause this disease have also led to the deaths of pregnant women. For this the influenza vaccination is strongly recommendedespecially if the pregnancy is in progress between October and February, that is, in the months in which the flu is more widespread» clarifies the pharmacologist.
These vaccinations should be avoided during pregnancy
«The vaccines we use are all safe, but some must not be given during pregnancy. It’s about those with “attenuated virus”like the one for the rubella or the “old” Sabin vaccine for polio» explains Alfredo Vannacci, who is also the university manager for the Pharmacovigilance Center of the Tuscany Region. Those with mRna against Covid-19, on the other hand, are safe even during pregnancy. «No woman had used them before the pandemic. Yet they have proven to be more than reliable, because the safety of vaccines and drugs is also demonstrated with non-clinical studies ». What remains to understand is how high is the protectionhow long it lasts. If it is the same in all new mothers or if it changes according to their age, or health status. This and other information will collect and elaborate the new research project which is funded by Pnr (2021-2027).
Nausea is one of the “companions” of pregnancy. Better to try to keep her under control with gherkins that she immediately resorts to drugs. (Getty Images)
It will also improve knowledge of anxiolytics & Co.
A book could be written on medicines and pregnancy. With many many pages. Word of mouth among mothers claims that “the fewer drugs you take, the better it is for your belly”. This is true, but only partially. “Advance” also wants to find out any risks associated with the use of a medicine that is indispensable and, as such, it cannot be suspended even during pregnancy. Let’s try to give a practical example: more and more women are taking “sleeping drops”. Beyond the endearment, some medicines against insomnia can cause serious damage in the nine months. Better to count the sheep then… «It’s another matter if you suffer from epilepsy. An epileptic seizure is worse than the problems that some medicines used to control the disease can cause» clarifies Vannacci. “Advance” will go to investigate just what they are the pros and cons of certain active principlesi in chronic diseasesfrom diabetes to hypertension, passing through psychiatric disorders.
Waiting for the results…
It will take at least three years to know the first results and understand how to improve the use of certain medicines and vaccines in pregnancy. And in the meantime? Anyone with a big belly and has to take medicines must do it only on doctor’s prescription, preferably a specialist in the sector. And even better if he works in collaboration with a gynecology department of a hospital. In short, do-it-yourself and word of mouth are good for choosing a stroller and pram. For drops and tablets, better ask for a consultation to the Perinatal Toxicology Center of the Careggi Hospital in Florence. Anyone can call him, both before taking a drug, and if you are following a therapy prescribed by a doctor and want reassurance about safety.
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