Image: Shutterstock/sukanya sitthikongsak Image: Shutterstock/sukanya sitthikongsak A CLINICAL TRIAL at the Rotunda Hospital funded by a biomedical company has been criticised for the way it presents information on risks and benefits of induced labour to pregnant women.
Currently, the HSE says labour is generally induced if the baby is overdue, a person’s waters have broken but labour hasn’t started, or if the health of the woman or the baby is at risk. The trial is examining two well-known induction methods, one medical method and one mechanical method. This will be the first trial to assess these methods at this gestation in the outpatient setting. The trial is funded by Medicem Technologies and a grant from the Rotunda Foundation. Medicem is the company behind Dilapan-S, a product being used in this trial.
To us that appeared to be a very early gestation to be offering an induction for first-time mothers who have no medical indication for that. It says the study will “potentially benefit all pregnant women who would be able to partake in outpatient induction of labour at 39 weeks, potentially reducing their overall risks and overall caesarean section risk”. We also felt that in the participant leaflet and the poster advertisement, there was an appearance of overplaying the potential benefit while not giving the same attention to potential risk.
The trial was conducted in hospitals in the US. Its results said women who were induced spent more time in the labour and delivery unit, but spent less time in postpartum hospitals. The information leaflet about the trial does highlight that women should clearly understand the risks and benefits of partaking in the study, and that not taking part will not impact their current or future medical care.In terms of the benefits outlined, the leaflet said induction at an earlier stage can decrease your risk of needing a C-section and decrease the risk of “complications for you and your baby”.
“We’ve had numerous contacts directly with women with screenshots of the advertisements inviting healthy women with normal pregnancies – no risk factor whatsoever – to take part in the clinical trial,” she said. “People have reasons for wanting and choosing an induction, but in general it’s not something people choose when they don’t have to.”Dr Susann Huschke, a health researcher, doula and co-founder of the Irish Birth Movement, believes the information provided to women in the leaflet is “misleading and downplays negative effects of non-essential inductions at 39 weeks”.
MichealMartinTD when you spoke about restrictions being lifted didn’t you allow maternity hospitals a get out of free card stating “we have to trust clinicians”!?!? 👏🏼 👏🏼 paulreiddublin DonnellyStephen AIMSIreland BirthMovementIE ReformMaternity RachAnnFagan