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Clinical Trial

Experts have 'concerns' about Rotunda trial involving induction of healthy first-time mothers

The trial is focused on home induction of women with uncomplicated pregnancies.

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.

The Home Induction Trial aims to assess two different methods of induction for healthy first-time mothers at 39 weeks pregnant. After the induction begins, they return home to await labour. 

The trial began in November 2020 and 86 women have so far taken part, the Rotunda said.  

However, academics and healthcare professionals in the women’s health sector have outlined a number of key concerns they have with the way in which the trial is being advertised and marketed to people who are pregnant and who may want to take part. 

They feel that an information leaflet about the trial is “overplaying the potential benefit” of inducing labour at 39 weeks. 

Some also take issue with the fact inductions are being offered in this way to women who have had no major complications in their pregnancies and who may not otherwise have needed to be induced on the basis of this information. 

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.

There is not a wide body of evidence available on the risks/benefits of inducing labour at 39 weeks, and people who spoke to The Journal said the potential negative aspects of an induction should not be overlooked when they are not deemed necessary.

Induced labour can feel more painful and lead to a higher likelihood of an assisted delivery using forceps or suction to help the baby out, according to the NHS in the UK. 

A spokesperson for the Rotunda Hospital said: “For those women who choose induction of labour at 39 weeks, little is known about the most effective method. The Home Induction Trial aims to assess methods of induction in the outpatient setting at 39 weeks in first time mothers.

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. 

The principal investigator is Professor Fergal Malone, the master of the Rotunda Hospital.


Valerie Smith, a professor in midwifery at the Trinity College Dublin school of nursing and midwifery, and her colleagues in this department sent a letter to the principal investigator of this trial in February. No response has yet been received. 

Professor Smith said their letter outlined concerns which arose after reading a patient information leaflet and a poster advertising the trial to women. 

“On that basis of reading and seeing both of those pieces of information, we sought some clarity around some of the way the information was presented,” Professor Smith told The Journal. 

“We do welcome inducing women at home and that option of care, however the trial itself has a policy of inducing at home using two different methods at gestations of 39 to 39+4 weeks [+4 refers to the number of days].

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. 

“Most international guidelines recommends induction of labour at 41 weeks and beyond so it appeared to be quite an unusual deviation.”

A patient information leaflet about the trial said it is researching the induction of labour at home, and determining the best way to induce women “safely and effectively”. 

Under a heading ‘Why is this study being done?’, the leaflet outlines a number of positives of inductions including that research examining outpatient induction “has found it to be safe, and often preferred by mothers as they are happier in the comfort of their own homes”.

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”.

Professor Smith said:

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 HSE said one of the main risks with inducing labour is that contractions could become “too frequent” which can harm the baby. 

There are no sources indicated in the leaflet, but details are included for two doctors involved who people are advised to contact if they are looking for additional information. 

“What it appeared to us from reading the information leaflet was that the information and source of the source of the information largely came from the ARRIVE trial,” Professor Smith said.

This is a trial published in 2018 involving pregnant women who were induced at 39 to 39+4 weeks. 

The trial said results showed a “significantly lower frequency of caesarean delivery” in people who were induced at 39 weeks compared to those who weren’t (18.6% vs 22.2%). 

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.

Professor Smith said: “The concerns we have is if the information being presented to women is based on that trial, it should be presented in the context of information for benefits of induction for labour in the context of hospital induction of labour, not at home.”

Further, she said there are a number of characteristics of the trial that women should be made aware of – including that the median age of participants was 24 years, 43.4% of participants were white and more than half had a BMI of 30 or over (categorised as obese). 

She said these concerns were expressed in the letter which further outlined their belief that the “information being presented to women for the ‘home trial’ falls short” of providing “sufficient information for informed consent”. 

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. 

The study will take place for 12-24 months or until 465 people participate, the leaflet said.

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”. 

It also said being induced early can allow for delivery before complications later in pregnancy – such as a baby being smaller, potentially reducing the risk of a baby’s shoulders getting stuck during delivery.

The risks mentioned include that contractions during the induction can be painful.

It added: “There is a small risk that any substance or device we use can lead to infection. This is unlikely as both [substances and devices] are sterile and inserted under sterile conditions.”

It said there is a “small risk” of developing uterine hyperstimulations, which is more than five contractions in ten minutes, or a contraction lasting longer than two minutes. However, it said this is generally reversed if the induction device is removed. 

‘Not used on healthy pregnancies’

Dr Krysia Lynch, chair of the Association for Improvements in Maternity Services – Ireland (AIMS), said women had contacted her group with questions and concerns about the trial. 

“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. 

“The viewpoint from them was that there was a lot of discussion about why you might want to be involved, but little discussion about why you might not want to be involved and the potential risks.”

Whilst it’s important to carry out research, it seems unusual to look at healthy women who would never be asked to have an induction anyways.

Dr Lynch added that “induction is a really useful tool” for those who have risk factors or for other reasons, but in general it’s “not used on healthy pregnancies”. 

She said some mothers may like the appeal of planning an induction date to have a baby in time for a big event or if they live far away from a hospital.

“People have reasons for wanting and choosing an induction, but in general it’s not something people choose when they don’t have to.” 

‘Downplays negative side effects’ 

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”.

Dr Huschke said: “It makes it sound like having an induction for no medical reason at 39 weeks is safer than waiting for physiological birth to happen.

I want women to know what they are getting themselves into.

She said it’s “horrific” that the experience of an induction for a first-time mother is ignored in the conversation about interventions in the leaflet provided.  

“It’s as if the experience of the mother doesn’t matter,” she said. 

Dr Huschke said she has tried to engage with the researchers and the ethics board who approved the trial but “nobody has ever responded to my emails”. 

Tracy Donegan, a midwife, received the patient information leaflet about this trial through a Freedom of Information request in February and is strongly critical of it. 

“It’s targeting healthy, well, first-time mothers who have absolutely no complications,” she said. 

She further criticised the “minimal mention of any risks” on the leaflet provided to women.

Donegan said several pregnant women reached out to her who claimed they were contacted directly by researchers about this trial.

The Journal asked a spokesperson for the Rotunda about this practice but no response was received before publication. The researchers involved in the trial were also contacted but declined to speak. 

Donegan said people considering the trial should “think really carefully about it and have an in-depth discussion with a midwife or obstetrician for the demonstrated risks of inducing”. 

Induction as part of the trial 

The trial leaflet said induction will start with one of two methods – the first involves inserting a small device into the vagina beside the cervix which will slowly release a hormone to ready the cervix for labour. People who don’t go into labour within 24 hours are examined again. 

The second type of induction is a mechanical induction – this involves inserting a gel-based device into the cervix.

This is a material that absorbs moisture from the cervix and expands to stretch the cervix, allowing it to open and break the pregnant person’s waters.

The researchers said that this may lead to contractions and labour, but with a reassessment if this doesn’t happen within 12-24 hours.

After the induction begins, if there are no concerns the women are discharged home for 12-24 hours. 

The leaflet said women are advised to return to hospital if they get regular contractions, if their waters break, or if there are any concerns about themselves or their baby. 

The leaflet noted that people can withdraw at any stage of the study.

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