Research into the safe use of medication during pregnancy

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Pregnant women sometimes need medication: for example, paracetamol to relieve the pain, or a medication for a life-threatening disease, such as cancer. 'We do not know yet whether each drug works during pregnancy and whether it is safe for both mother and child,' says Paola Mian. She is a scientist and hospital pharmacist at the UMCG and conducts research in the placental laboratory.
Ziekenhuisapotheker Paola Mian

Mian began researching how much paracetamol (acetaminophen) pregnant women need to relieve their pain, such as headaches or back pain. The normal amount of 4 grams of paracetamol spread over the day was safe for the baby but did not relieve the pain in pregnant women well. 'After my PhD research, I was able to say that women need about a third of as much paracetamol to properly relieve their pain, but is that higher dose also safe for the baby?'

Research on different drugs

With many medicines, the question is what the effects are on the unborn baby. Mian does not want to limit herself to paracetamol: she wants to find the best dosages of all kinds of medicines. For example, she has just received money for research into two drugs: trastuzumab, which works against certain types of breast cancer, and a combination of drugs against cystic fibrosis. This combination consists of ivacaftor, tezacaftor, and elexacaftor. 

Little knowlegde on how medicines work during pregnancy

'We know very little about how medicines work during pregnancy because as a society, we are afraid that a medicine will have the wrong effect on unborn babies.' But pregnant women also get sick and sometimes need medication. Doctors ask Mian for a lot of advice about this. 'Doctors want to treat a pregnant woman with a life-threatening illness properly, but they do not want to give an unborn child a dangerous drug. I then try to give advice: my research helps with that.'

Possible consequences for the unborn baby

Through her research, Mian learns a lot about how a drug moves in the body of a pregnant patient. The placenta plays a major role in this: the mother's bloodstream is in contact with the baby's, allowing nutrients – and in some cases medicines – to reach the baby. Mian investigates several things, such as how much a medicine reaches an unborn child through the placenta, whether a drug can cause birth defects in the child, and whether the child will lag in his or her development. 'If we map these points earlier with placental research, we will know how to adjust the dosage of a drug for the pregnant patient.'

Research with placentas

Mian conducts the research in the placental laboratory. She will receive permission from pregnant women to use the placenta for this study after delivery. 'We know when a cesarean section is scheduled at the UMCG. When a pregnant woman has a cesarean section, the researcher is sometimes literally waiting in the hallway. If the pregnant woman has given birth and is given the baby in her arms, the examiner will receive the placenta. When the researcher has the placenta, he runs to the lab, as it were, to do experiments. First, we rinse the placenta to remove blood clots and cells. Then we flush the medicine over the placenta.'

Predictions with a computer model

Mian's experiments yield figures that she can enter into a computer model. That model then predicts how the drug moves through the placenta. 'We can use the computer model to see how much medicine reaches the unborn child from the mother.' Mian can use this to predict the influence of a drug on unborn babies.

Guidelines on medications during pregnancy

With her research, Mian wants to create new guidelines about dosages for medicines during pregnancy. With this, she hopes that pharmacists will be able to give the best advice about medicines, so that mother and child receive the most effective and safe treatment. 'I really see it as something important to help children and pregnant women. It does something to me that these patients may not be getting the right treatment.' She adds: 'If the baby is still in the womb and still has 80 years ahead of it, with the right advice you can make a lot of impact and mean a lot to the child's life.'
 

Grants for research into medicines during pregnancy

Mian has received an NWO grant of 50.000 euros for her research into medicines during pregnancy. In addition, she has received a grant from the Gratama Foundation: they gave 25.000 euros for research into trastuzumab. The Dr. C.J. Vaillant Fund also gave a contribution of 15.000 euros for research into the combination drug against cystic fibrosis ivacaftor, tezacaftor, and elexacaftor).