Thursday, 19 March 2015

Draft Clinical Guidelines for Maternity Care skirt around the issue of informed consent... Again.

Draft Clinical Guidelines for Maternity Care skirt around the issue of informed consent...Again.

Today's Medical Independent ran a piece by Catherine Reilly, "SCA concerned over Executive’s draft clinical oxytocin guideline" in which a survey by the State's Claims Agency expressed concern that draft Irish clinical guidelines, on the use of syntocinon (oxytocin) in maternity services, have no reference to obtaining informed consent.
“There is no reference to obtaining informed consent in the draft guideline under development. Clearly, this is an area that must be addressed,” it stated. “In Ireland, a “substantial number” of claims suggest oxytocin as a causative/contributory factor, it also reported."
Further, the article references claims by a HSE spokesperson who said "at present it is not aware of any national or international guidelines to guide practice on oxytocin augmentation in labour."
A claim that AIMS Ireland have previously refuted on this blog, here: "FAO: HSE - A helpful synopsis of well respected Clinical Guidelines on the use of Synthetic Oxytocin"
Irish National Clinical Guidelines - Informed Decision Making
In the past, AIMS Ireland provided recommendations to Irish draft clinical guidelines - for the VBAC guidelines and Pregnancy and Obesity guideline (2011).
In both instances, AIMS Ireland commented on how guidelines failed to acknowledge informed consent / informed refusal; a key principal of patient centred care. AIMS Ireland recommended that each guideline reference informed decision making, suggesting wording from NICE Clinical Guidelines as a high quality resource. In neither instance were these recommendations implemented.
AIMS Ireland Recommendations to draft clinical guidelines (2011):

Below is our recommendation following consultation for the Pregnancy and Obesity draft guideline, submitted in 2011, in which we clearly reference this issue.

"1. There is no reference for women’s right to informed consent and/or informed refusal or women-centred care on recommendations made within the Guideline. AIMS Ireland would like to see the inclusion of women’s rights to informed consent/refusal and an outline of women-centred care principals within each of Ireland’s Guidelines as per NICE Guideline 55, Intrapartum Care. NICE have used the following introductory forward for their Guideline which we feel is excellent: "

"Women and their families should always be treated with kindness, respect and dignity. The views, beliefs and values of the woman, her partner and her family in relation to her care and that of her baby should be sought and respected at all times. The woman should be fully involved in planning her birth setting so that care is flexible and tailored to meet her needs and those of her baby.

Women should have the opportunity to make informed decisions about their care and any treatment needed. If a woman does not have the capacity to make decisions, healthcare professionals should follow the Department of Health guidelines ‘Reference guide to consent for examination or treatment’ (2001) (available from

Good communication between healthcare professionals and the woman and her family is essential. It should be supported by the provision of evidence-based written information tailored to the needs of the individual woman. Care and information should be appropriate to the woman, and her cultural practices should be taken into account. All information given should also be accessible to women, their partners and families, taking into account any additional needs such as physical, cognitive or sensory disabilities and inability to speak or read English."

#WMTY14 Survey - Consent

In the 2014 AIMS Ireland survey, of nearly 3,000 women whom have given birth in Ireland from 2010-2014, What Matters to YOU? 2014, the issue of informed decision making (informed consent and informed refusal) was looked at in depth.

The survey found that informed consent and informed refusal remain an issue of concern in Irish Maternity Services, with the use of Syntocinon / Oxytocin referenced in comments from women as a specific issue.

Many women expressed that while basic consent was sought, they felt they did not have a choice.  Results also showed a failure to have full benefits, risks, and potential implications for having and not having a test, treatment or procedure explained to them.

"I repeatedly impressed my wish not to have oxytocin and this was disregarded and I was treated like I was being silly. I reluctantly agreed but I felt badgered into submission rather than consenting.”

“Formally yes (consent was obtained), but I wasn’t in favour of being induced, it was never presented as an option but rather as a decision made on my behalf.”

The Full #WMTY14 survey results on Consent can be read here:

In the same survey, 44.6% of first time mothers surveyed said they received Syntocinon / Oxytocin in the first stage of labour, while 20.4% of first time mothers surveyed said they received Syntocinon / Oxytocin during the second stage (pushing). *

These figures are worryingly high and suggest an inappropriate use of synthetic oxytocin outside of evidence based recommendations.

All women should be fully informed of the benefits and risks of synthetic oxytocin in order to facilitate women in informed choice.

Syntocinon/ Pitocin /Oxytocin is a synthetic version of a hormone present in labour which stimulates contractions. Synthetic Oxytocin is routinely used in Irish maternity units to synthetically start (induce) or speed up labour. It is a common component of Active Management of Labour, in which a woman's labour is managed by health care providers, using intervention and drugs, to 'speed up' process. Synthetic Oxytocin is linked to an increase of adverse effects for women. A recent study has also suggested that synthetic oxytocin is an independent risk factor for adverse effects in full term newborns.

* Syntocinon/Oxytocin is a common drug used in maternity units to either induce labour or to accelerate labour.
 * ACOG have cited Sytocinon/oxytocin is an independent risk factor to adverse effects on babies and also is shown to increase adverse effects in birthing women.
* Syntocinon is an independent risk factor for unexpected admission to NICU for fullterm infants lasting more than 24 hours and lower APGAR scores.
* Syntocinon/Oxytocin is an active agent used in Irish units to manage how long women labour.
* In hospitals with a strong Active Management of Labour ethos, half of women will have Syntocinon/Oxytocin in the first stage of labour.
* Sytocinon is routinely used in Irish units by injection to manage the birth of the placenta (3rd stage of labour). The majority of women in Ireland have a managed 3rd stage and many local units have it as policy that the 3rd stage should be managed.
* The makers of syntometrine (syntocinon) specifically state it is not safe to give to women who are breastfeeding/planning to breastfeed their babies

* Note, these figures are total figures for all first time mothers surveyed, inclusive of those using midwife led units and homebirth where syntocinon is not used.

AIMS Ireland Recommendations

It is inconceivable that a health system can stand over guidelines which fail to protect the basic rights of those using the service. Women make good decisions. Provisions must be in place to ensure that each woman is supported to make the best decision for her and her baby in her specific circumstances.

AIMSI would recommend that the issue of consent and provision of unbiased, complete information become areas of importance with Irish maternity units. “Hospital Policy” should not over-ride or give illusion of consent and individual choice for care options, admission, and opting in or out of procedures, tests and treatments. Consent policies should be revisited and printed material become available for every woman booking into maternity units.

Women should be informed of all the benefits, risks, and potential implications for themselves and their baby to have or not have procedures, tests, treatments, and interventions in order to make the best decisions in their circumstances. Women cannot truly give consent unless they understand what it is they are consenting to and are supported in these decisions by health care providers.

AIMS Ireland recommend strongly that a National clinical guideline is implemented to support the principals of informed decision making in Irish maternity services. To facilitate guidance of this, obstetric units should be under obligation to implement already existing National clinical guidelines for evidence based care rather than routine policy which relies heavily on medical management.

Full article in Medical Independent here:

1 comment:

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