‘Studies must find room for moms-to-be’

Research says clinical trials exclusion unfair

Pregnant women get bossed around by doctors‚ relatives and strangers dispensing advice on what’s best for their baby.

But a new study says the coercion of mothers-to-be – in particular their exclusion from clinical studies – is unfair and potentially harmful.

Doctors Carleigh Krubiner and Ruth Faden from Johns Hopkins University in the US‚ said there was a need to “protect women through research‚ not just from research”.

For example‚ 97% of 172 drugs approved in the US between 2000 and 2010 have an “undetermined risk for pregnancy” because they have not been tested on pregnant women.

“There is a pressing need to ... gather hard evidence‚ because drugs such as antibiotics and treatments for asthma and nausea are increasingly being prescribed to‚ and taken by‚ pregnant women‚” said the lead author‚ Indira van der Zande‚ in the Journal of Medical Ethics.

Operations manager of the SA Depression and Anxiety Group‚ Cassey Chambers‚ said they received calls from women nervous about taking medications while pregnant.

“While there are no clinical studies testing the effect of medication during pregnancy and the impact on the unborn baby‚ there is a lot of research that tests the impact of untreated mental illness during pregnancy on the baby‚ and [it] can result in a very negative impact on both the mom and the baby‚” said Chambers.

“We always recommend that someone ... works with both their obstetrician/gynaecologist and their psychiatrist to formulate a treatment plan for the pregnancy.”

Blanche Rezant‚ the parentinfant programme manager of The Parent Centre‚ said the organisation aimed to equip pregnant women to make informed choices.

“Nursing staff and paediatricians say different things to women. We take the information to them and they weigh up the pros and cons for themselves and talk to a counsellor about what to do‚” she said. “We do not prescribe to women and our stance is not judgmental.”

After analysing 13 studies on the topic‚ the authors of the latest research challenged the assumption that pregnant women are a “vulnerable group”.

Internationally‚ scientific and ethical committees controlling trials are starting to realise they need to include pregnant women – for example‚ with the emergence of the Zika virus.

Typically‚ however‚ the needs of moms-to-be come second to the unborn babies when