Why has the Labour Ward gone to the Dark Side?

AIMSI welcomes this guest blog post from Dan Oakes, RM and Founder of Neighbourhood Midwives

Following the recent revelations about Irish maternity care in the news and social media, I wondered why there are so many different approaches to providing care to a mother in labour. The stories range from having an empowering midwife to a controlling obstetrician, a cruel midwife to a lifesaving obstetrician. Can it be that hard for all caregivers to provide consistent, respectful care? Or is something else at play here?

I am an avid video game enthusiast. I particularly like strategy/city building games. In many of the games I play, the player must choose to rule the subjects in their kingdom either with an iron fist or gentle care. Usually the cost of being a good ruler is higher in terms of time and money, but subjects are far more productive than the kingdom run by an evil player.

These observations are not exclusive to the fictitious video game world. They come right out of what we know of human history and science. Let's look at the situation through the lens of the Stanford Prison Experiment. Zimbardo (2008) writes in The Lucifer Effect: Understanding How Good People Turn Evil that it is not the bad apple that ruins the barrel, rather a bad barrel contaminating the apples. Does this theory mean it is the system that turns practitioners into monsters? Suffice it to say, we can all relate that it takes more time and effort to be kind to our fellow human beings; in fact, it is much easier to be flippant, uncaring and brusque, especially when we are under tremendous pressure.

Are the people helping women in labour in Ireland under tremendous pressure? In the recent prime time report on Portlaoise, the HSE reported that the midwives there are working at a ratio of 1:75. Considering the maximum ratio should be 1:28, I would hazard that not only are the staff under extreme pressure, but also actively encouraged to do whatever it takes to get mother and baby out of the delivery rooms as quickly as possible.

So why does it matter if practitioners are mean, taciturn and overworked? Politicians would say all that matters are the results - baby and mother alive at the end of the day. There. Job done. At what cost? If someone behaves horribly to a woman in labour, her levels of cortisol go through the roof. Cortisol is an antagonist to oxytocin and oxytocin is needed for strong contractions. This means when the woman is stressed by an unrelenting battleaxe in the labour ward, her contractions turn off or become weaker. Labour is lengthened, or stops altogether and then the artificial oxytocin is started. While research is still out about the safety of this particular drug, practitioners know it has a terrible effect on the baby. When syntocinon is used, we have to strap on a continuous fetal heart monitor (CTG) because the effect on the baby has to be measured to determine if the benefit continues to outweigh the risk in a given situation. Research proves that the use of the CTG increases the likelihood of Caesarean section. Again politicians say big deal: our caesarean section rates are acceptable, have you not seen our infant mortality rate?

Caesarean sections are a much larger drain on the system than vaginal deliveries. Emerging research is showing vaginal birth is the key to our immune systems as adults. Without vaginal birth, non-communicable diseases will bankrupt our health system. Not to mention, emergency caesareans can leave mothers and fathers mentally and emotionally scarred. Fewer caesareans would also leave more money to address the atrocious care ratios.

The HSE promises they are looking for strategies for reducing the caesarean rate in Ireland. How about starting with anger management and communication training for all the midwives and Ob/Gyns?

For more information on maternity services in Ireland, please see www.42weeks.ie

To read real stories of the Irish maternity services, please see here: 'Shout Back - Your Say'

and here: AIMS Ireland

AIMS Ireland AGM: Saturday December 7, 2013

                       AIMS Ireland AGM

When:  Saturday, December 7, 2013
Time:    2:30PM
Where: Teacher's Club, Parnell Square, Dublin (across from Rotunda)
Directions: http://www.clubnamuinteoiri.com/

 Speakers

 
"Daughters of the Revolution, Theatre Workshops" - Kate Harris of 4 Elements Theatre Company

 
AIMSI member, Nuala Hoey is speaking about her personal experience of birthing decisions and positive birth choice.

 
"Neglecting Reproductive Autonomy : A legal analysis of consent during pregnancy and childbirth in Ireland" - Barrister, Mary Kirwan


AIMS Ireland AGM

* 2012-2013 Committee Annual Report
* Proposed Motions and Business
* Election of Committee Roles

AIMS Ireland Members: Proposed Motions and Business

Any proposed motions or business for AIMS Ireland in the upcoming year are to be submitted by email to Chair@aimsireland.com by 5pm, Thursday December 5th.

 Committee Roles

AIMS Ireland need to elect all committee roles at the AGM. We are currently taking nominations.

To be eligible for Committee Roles with AIMSI you must fit the following:

* member of AIMS Ireland
* cannot be a medical professional
* be available and willing to commit to a year in elected position

AIMS Ireland Committee Roles:

Secretary
Treasurer
Membership
Press Officer
Women's Support and Information Aide
Events/Fundraising
** Chair
** Vice Chair

** Chair and Vice Chair may be split as Co-Chair if preferred and agreed with committee


AIMS Ireland are also seeking assistance with non-committee roles in a voluntary capacity with issues such as event planning, fundraising assistance, campaigns, surveys/research, graphic design (infographs), video production, etc. If you have skills you would like to contribute to AIMSI please contact us at info@aimsireland.com

 Membership to AIMS Ireland is €20 for a year. Membership entitles you to membership of a private AIMSI online facebook group and election/vote of committee roles and motions. Membership fees go back into women's support services. Please Join Us!! http://www.aimsireland.com/join/?topic=join

Fundraising/Donations to AIMS Ireland go directly to AIMS Ireland research, support services and campaigns. If you would like to organize an event in the aide of AIMS Ireland, please contact us at info@aimsireland.com

AIMS Ireland receives no outside funding - fundraising, donations, and membership provide our sole financial support and go straight back to campaigns and women's services.

Annual Organizational and Financial Reports from AIMSI for 2012-2013 will be made available at the AGM.

Our amazing Treasurer, Alcarine Power, has recently resigned following 5 amazing years with AIMSI. We are so sad to see her go and will miss her immensely.

 Thank You,

AIMS Ireland Team

AIMSI 3 PQ's regarding Misoprostol Dosage Guidelines & Bimbo Onanuga

QUESTION NOS:  638 to 640

DÁIL QUESTIONS addressed to the Minister for Health (Dr. James Reilly)
by Deputy Clare Daly
for WRITTEN ANSWER on 19/11/2013  

 
 *  To ask the Minister for Health if all 11 recommendations following Health Service Executive investigations following the death of a person (details supplied) including number seven, have been fully implemented in the Rotunda Hospital, Dublin.

                                                                                          - Clare Daly T.D.

For WRITTEN answer on Tuesday, 19th November, 2013.

Details Supplied: Bimbo Onanuga

*  To ask the Minister for Health if the Rotunda Hospital, Dublin, have updated their guidelines on the management of intrauterine death to include lowering the dosage of Misoprostol to reflect recommended standards in RCOG.

                                                                                          - Clare Daly T.D.

For WRITTEN answer on Tuesday, 19th November, 2013.

*  To ask the Minister for Health the reason the RCPI/IOG guidelines regarding the use and dosage of misoprostol were not implemented, as per Health Service Executive recommendations.

                                                                                          - Clare Daly T.D.

For WRITTEN answer on Tuesday, 19th November, 2013.

Details Supplied: (Note the October 2013 published HSE guidelines remain unchanged and do not reflect what was recommended following the death of Bimbo Onanuga)?

 
REPLY.
As I responded to the Deputy in my reply of 13th October last, I have been advised that the circumstances surrounding this patient's death were investigated by the HSE under the National Incident Protocol following which 11 actions were recommended.  I have been informed by the HSE that the Rotunda Hospital has now implemented all 11 recommendations.  

In relation to the other issues raised by the Deputy, as these are service matters, I have referred them to the HSE for attention and direct reply.

Minister for Health James Reilly rejects calls for a HIQA review into the death of Bimbo Onanuga

AIMS Ireland last week welcomed the verdict of medical misadventure in the Coroner's Court following the inquest into the death of Bimbo Onanuga in the Rotunda in March 2010.

Bimbo Onanuga died following a medical induction with Misoprostol/Cytotec 29+ weeks into her pregnancy due to the intrauterine death of her baby. Eyewitness accounts describe a catalogue of errors and failures to provide basic care to Bimbo that day.

Following the coroner's verdict, supporters (academics, medical professionals, oganizations and friends) of Bimbo Onanuga, including AIMS Ireland, called for a HIQA review into the failures of basic care and treatment Ms Onanuga received in the Rotunda Hospital in March 2010.

AIMS Ireland reported that there were "Echoes of both Savita and Tania McCabe once again at inquest of Bimbo Onanuga today..." More: http://nocountryforpregnantwomen.blogspot.ie/2013/11/a-matter-of-public-interest-aimsi-calls.html

A HIQA review would be in line with actions taken by the Minister following the death of Savita Halappanavar.

A PQ (Parliamentary Question) was put into the Dáil to the Minister for Health, James Reilly by Deputy Clare Daly.

The Minister has rejected calls for a HIQA review - denying an investigation into the systematic failures of care and treatment Bimbo Onanuga received in the Rotunda Hospital in Dublin.

AIMS Ireland is extremely concerned by the lack of accountability and continued significant efforts to hide the circumstances of Bimbo’s death.

It is astonishing that  given the similarities of failures on record, the Minister has chosen to act, calling for an independent HIQA review into one woman's death, while refusing the other.

The PQ and Reply:

QUESTION NO:  22

DÁIL QUESTION addressed to the Minister for Health (Dr. James Reilly)
by Deputy Clare Daly
for ORAL ANSWER on 13/11/2013  

 
 To ask the Minister for Health if he will order a Health Information and Quality Authority investigation into the circumstances of the care of a person (details supplied) in line with the HIQA investigation into the death of Savita Halappanavar.

                                                                                         Clare Daly T.D.

Details Supplied: An inquest into the death of Ms Bimbo Onanuga concluded on 5 November with a coroner’s verdict of medical misadventure. In the course of treatment in the Rotunda Hospital on 4 March 2010, Ms Onanuga suffered a catastrophic incident and was transferred later that day to the Mater Hospital where she died. The details of her case as laid out in the Coroner’s Court raise fundamental issues about her care and treatment. Will the Minister order a HIQA investigation into the circumstances of Ms Onanuga’s care, in line with the HIQA investigation into the death of Savita Halappanavar.?

 
REPLY.
I would like in the first instance to offer my sympathies to the family involved in this very unfortunate case.

I have been advised that the circumstances surrounding this patient's death were investigated by the HSE under the National Incident Protocol following which 11 actions were recommended.  I have been informed by the HSE that the Rotunda Hospital has now implemented all 11 recommendations.  

I am advised by my Department's Chief Medical Officer that it is not necessary nor is it appropriate for me to request the Health Information and Quality Authority (HIQA) to undertake investigations in a case such as this which has been adequately investigated under the HSE's incident management procedures.  

It is important to state that maternal and peri-natal health statistics indicate that Ireland continues to be a very safe country for a woman to give birth and our safety record compares favourably with other developed countries.

AIMS Ireland calls for a HIQA review into the Death of Bimbo Onanuga and the Catalogue of Sytematic Failures in Basic Care.

AIMS Ireland last week welcomed the verdict of medical misadventure in the Coroner's Court following the inquest into the death of Bimbo Onanuga in the Rotunda in March 2010.

Bimbo Onanuga died following a medical induction with Misoprostol/Cytotec 29+ weeks into her pregnancy due to the intrauterine death of her baby. Eyewitness accounts describe a catalogue of errors and failures to provide basic care to Bimbo that day.

AIMS Ireland are calling for a HIQA review into the death of Bimbo Onanuga

A Catalogue of Sytematic Failures in Basic Care


* Despite conflicting reports, Bimbo Onanuga disclosed her full medical history on booking at the Rotunda. Women are encouraged to disclose full histories in order for their care team to pre-empt any complications which may arise following some medical histories. Gynaecological procedures and investigations, abortion, surgery, injury, previous mode of birth, and more are all histories in which can affect the care paths of women.

* It is the responsibility of maternity providers to ensure individual assessment and appropriate care to women, regardless of her history. It is also the responsibility of maternity providers to inform themselves of women's previous history in order to develop the safest care plan for each woman taking into account her medical history, current pregnancy, her concerns, informed choice, and potential complications.

* It is the responsibility of care providers to listen to concerns raised by women and their families. AIMS Ireland encourage women and their birth partners to express concerns, unusual sensations or pain, if something doesn't 'feel right', and side affects to their care providers. It is the duty of care providers to listen.

* It is the responsibility of maternity providers to ensure that all staff are fully trained on how to provide basic clinical observations and record them in a timely fashion.

Bimbo's failure of basic care

* Bimbo Onanuga was nearly 30 weeks pregnant and was medically induced with Misoprostal on the Gynaecological ward rather than the labour ward.

* One of the principal carers for Bimbo Onanuga during the time of her induction on the gynaecological ward of the Rotunda Hospital was a nurse, not a midwife. The necessary clinical skills for diagnosis and treatment of labour, induction, complications, and basic issues such as experience in palpitation of the uterus are outside the scope of practice for a nurse and require the professional skills of a midwife.

* Bimbo was administered two doses of Misoprostol of 200mcg at three hour intervals - one vaginal and one oral. Recommendations from RCOG state that (I) induction of labour using Misoprostol is not recommended (II) Misoprostol should only be given orally, not internally (III) recommended dosage is 50-100mcg by four hours.

* Misoprostol is an off-label drug. This means that staff are not required to record adverse outcomes relating to this drug. Misoprostol has been linked to uterine hyperstimulation  and uterine rupture in women with scarred and unscarred uteri. There have been recorded instances of rupture in first time mothers whom were given Misoprostol for induction of labour.

 * Bimbo reported to be in 'constant' pain. It is reported that Bimbo was told as the pain was constant, rather than waves of contractions, she was not in labour. Concerns raised by Abiola that Bimbo was experiencing constant and severe pain were reportedly ignored and midwife Shiela Lynch is reported to have said she was exaggerating. Constant and severe pain is unusual and suggests something is out of the normal progression of induction. This was not recognized as 'abnormal'.

* Bimbo's partner Abiola reported that Bimbo could not breath or talk. His attempts to raise the alarm were not followed through.

* On Bimbo's collapse, it was Abiola who first initiated CPR

* It is reported that on Bimbo's collapse the available machine for measuring blood pressure appeared not to be working. Rather than taking the blood pressure manually, staff spent time attempting to get the machine working again.

 * On Bimbo's collapse the medical team prepared for an emergency Caesarean Section. However the bed was too large to fit through the door of the Gynaecological ward and subsequently, an immediate Caesarean Section was instead performed on her bed on the Gynaecological ward.

* There are concerns relating to the medical notes the day Bimbo died. Notes were retrospective, out of sequence, were incomplete, and clinical observations were not recorded.

* Following Bimbo's death investigations were undertaken very quietly through the HSE. At no point was any information made public. Bimbo's death did not receive a full HSE inquiry. Bimbo's death did not receive a public apology. Following 3 PQs, recommendations into HSE investigations into Bimbo's death were released.

* Following the PQs, the HSE released a statement expressing its sincere sympathies to the family involved. However, the family were not contacted directly and are unaware of the statement

* The initial request for an inquest into the death of Bimbo Onanuga was denied by the Coroner ruling she died of natural causes. This was later reviewed and an inquest was granted.


  These are the recommendations from the HSE following investigations into Bimbo Onanuga's death:

1. The need to identify clinical pathways relating to management of women with an intrauterine death in third trimester to complement existing medical management policy.

2. The Guidelines for Medical Management of Intrauterine Death should be revised in line with a review of the medical literature.

3. Details of all patients for Induction of Labour, regardless of place of induction should be centrally documented.

4. This recommendation cannot be disclosed as it contains personal, private, sensitive and confidential information relating to the individual patient.

5. Develop a brief operational outline of the Gynaecology Department to assist staff who are sent there on an occasional/intermittent basis.

6. Due to the complexity of work, there is a need for an updated training needs analysis of all midwifery and nursing staff on the gynaecology ward.

7. There should be a designated individual with responsibility for coordinating, monitoring and auditing the Basic Life Support attendance and Advanced Life Support Skills attendance, ideally a designated Resuscitation Training Officer.

8. An Obstetric Early Warning System should be introduced and evaluated.

9. Install additional phone lines in the ward.

10. A review of the possibility of emergency call bells or designated phones for emergencies in each room should be carried out and measures taken to address this.

11. Hospital wide analysis of all doorways in clinical areas to establish the feasibility of moving a bed in a critical event.

The Rotunda is reported as having changed their guidelines for the management of intrauterine death and fully implementing the 11 HSE guidelines.

However, it is important to note that guidelines on the HSE/RCPI/IOG websites (revised October 2013) are unchanged and recommend the same management guidelines which were in place the day Bimbo died; Misoprostol dosage and scheduling 200mcg by 3 hours.

AIMS Ireland call for a full HIQA review into the death of Bimbo Onanuga and review of guidelines for Management of Intrauterine Death to come in line with those of the UK and RCOG

A Matter of Public Interest - AIMSI calls on transparency & accountability following details into death of Bimbo Onanuga. Press Release: Echoes of both Savita and Tania McCabe once again at inquest of Bimbo Onanuga today, according to maternity advocacy group. AIMS Ireland calls for accountability and clinical review following verdict of misadventure as a matter of 'public interest'

Echoes of both Savita and Tania McCabe once again at inquest of Bimbo Onanuga today, according to maternity advocacy group

 

AIMS Ireland calls for accountability and clinical review following verdict of medical misadventure

Press Release:

(Tuesday, November 5, 2013) The Association for Improvements in the Maternity Services Ireland (AIMS Ireland) today petitioned for accountability, a review into clinical care practices, and national guidelines on the use of the drug misoprostol (cytotec) following the verdict of medical misadventure returned at the inquest into the death of Bimbo Onanuga at the Dublin Coroner’s Court today. Bimbo Onanuga's inquest has once again exposed underlying critical flaws in basic clinical care within an Irish maternity unit, echoing concerns raised following reports into the deaths of both Savita Halapanavar and Tania McCabe.

The HIQA report into the death of Savita Halapanavar published last month found ‘The most basic means of identifying any patient at risk of clinical deterioration is to observe the patient’s general condition and regularly monitor and track their clinical observations. This should be a basic component of caring for any patient.’ Abiola Adesina, Bimbo Onanuga’s partner, told the inquest yesterday that Bimbo was rolling around and in constant pain following admission to the Rotunda Hospital in March 2010 and that attempts to raise concerns were disregarded as a normal progression of labour. Bimbo, who had a number of risk factors in relation to the intrauterine foetal death, had received misprostol (cytotec) to induce labour.

Krysia Lynch, Co-Chair of AIMS Ireland, commented "The parallels between Savita, Tania, and now, Bimbo, are staggering. We see once again a catalogue of basic fundamental failures from a lack of documentation to basic clinical observations. Most crucially, we once again see a comprehensive failure by health care providers to listen to women. This is a reoccurring complaint from women contacting AIMS Ireland - they do not feel their concerns are acknowledged or listened to. In a critical medical event, this can be the difference between recovery or death."

On the issue of the use of the drug cytotec, Lynch added "Misoprostol has been linked to uterine rupture  in women with and without scarred uteri and is not recommended for use in induction. The Royal College of Physicians in Ireland (RCPI) guidelines on cytotec use sit outside those of the Royal College of Obstetricians and Gynaecologists (RCOG) in the UK, which raises a red flag and unanswered questions. AIMS Ireland is calling for full accountability and transparency. We ask the Rotunda, did Bimbo receive the basic care, monitoring and a care plan consistent with her clinical needs? Was she appropriately and effectively monitored given the use of the drug misoprostol? Has the Rotunda taken proper and appropriate steps to update staff about the use of the drug misoprostol? Why do their guidelines continue to sit outside those of the RCOG? We also raise concerns regarding queries to the disclosure of Bimbo's previous termination at the inquest. Our sources have revealed that this history was fully disclosed and this information was available to care providers. From the onset, the Rotunda hospital has made attempts to conceal information relevant to the case - including a litany of errors, mishaps, and failures of basic care to Bimbo. We publicly call on the Rotunda to clarify on these matters. This is a matter of public interest."

Concluding, Lynch said “We very much welcome this verdict of medical misadventure from the Coroner Brian Farrell. Despite significant efforts to hide the circumstances of Bimbo’s death, the truth is now on public record. After fighting for many years for this inquest and to have her story heard, Bimbo’s family is finally vindicated.”

ENDS

 

For further information, contact:

Krysia Lynch, AIMS Ireland 087 754 3751

Jene Hinds Kelly, AIMS Ireland 087 681 9095

UK & Irish guidelines on the use of Cytotec/Misoprostol for medical induction of labour after an intrauterine foetal death (IUFD)

RCOG Guideline

The RCOG Green-top Guideline No.55 Late Intrauterine Fetal Death and Stillbirth, published in October 2010 recommends the use of low doses of misoprostol (50 or 100 micrograms depending upon gestational age) when inducing labour:

“The RCOG is aware that protocols employing much larger doses of misoprostol are still being employed in the UK, with consequent potentially associated adverse effects. Each maternity unit is advised to review their protocol for the management of induction of labour under these circumstances and to adopt the recommended misoprostol dosaging. Currently, misoprostol is only available in the form of a 200 microgram tablet; however the required dosage of 50 or 100 micrograms can be obtained by cutting the tablet or by dilutional methods. Your hospital pharmacist will be able to assist you with this if necessary.”
http://www.rcog.org.uk/...

RCPI Guidelines

Royal College of Physicians I reland (RCPI) Guideline: #4 Intrapartum fetal heart rate monitoring - Appendix 4:
http://www.rcpi.ie/article.php?locID=1.5.71.492

On the day of diagnosis of IUFD
Mifepristone 200mg PO
36-48 hours after diagnosis
24-34 weeks Misoprostol 200mcg PV followed by 200mcg PO 3 hourly x 4 doses
>34 weeks Misoprostol 100mcg PV followed by 100mcg PO 3 hourly x 4 doses
A second course may be started after 24 hours and with medical review

Cytotec (Misoprostol) drug label: http://www.rxlist.com/cytotec-drug.htm

Cytotec/Misoprostol - Research

A 2006 Cochrane Review of Misoprostol for induction showed that while oral use of Misoprostol was shown to be an effective induction method, this is not without increased risks. Misoprostol increases risk of uterine hyperstimulation. The uterus may contract too frequently (more than five contractions in 10 minutes), the contractions may last too long (2 minutes or more per contraction), or the uterus may not relax enough between contractions. A casual relationship between uterine rupture and use of Misoprostol in scarred and unscarred uteri is acknowledged, Cochrane notes this requires further investigations but is a cause for concern.

Unfortunately, it is almost impossible to show true risks of misoprostol in induction of labour, because according to the Cochrane review (2010) - "It is not registered for induction of labour, and has therefore not undergone the systematic testing for appropriate dosage and safety required for registration".

The 'off label' use makes it a drug that has never been through rigorous clinical trials and it is, by proxy, not subject to reporting of adverse reactions or outcomes.

 

How many maternal deaths invoving Cytotec have to happen before it is removed from 'off label' use?

 

We'll never know, because no one records Cytotec as a cause or a factor in these deaths.

In the inquest of Bimbo Onanuga, Rotunda's Sam Coulter-Smith is on record as saying:


"Dr Coulter-Smith said there are risks when using misoprostal if there has been previous scarring or perforation of the uterus, but there was nothing in Ms Onanuga's medical notes to indicate such a risk." (RTE news)

"A post-mortem examination later revealed that there was scarring due to a previous termination of pregnancy. But that knowledge came only in hindsight." (RTE news)

AIMS Ireland Counter-Points:

* Undisclosed sources to AIMS Ireland report that Bimbo Onanuga was upfront about her previous termination and report that this information is in her booking notes.

* The occurrence of uterine hyperstimulation and instances of uterine rupture following Misoprostol have been reported in women with scarred and unscarred uterus.

From the Cochrane Review 2010:

"There have been several reports of uterine rupture following misoprostol labour induction with and without previous caesarean section (Bennett 1997; Sciscione 1998; Blanchette 1999; Matthews 1999; Khosla 2002). One unpublished case of uterine rupture occurred in a nulliparous woman following misoprostol use (EM Smith, personal communication). At term plus 12 days she received misoprostol 100 mcg vaginally. After six hours her cervix was found to be 7 cm dilated, and she progressed to full dilatation within a further 70 minutes. Fetal distress was suspected. Ventouse application produced no descent, so delivery was effected by caesarean section. The infant showed no signs of life at birth. After resuscitation, life was sustained for a few hours only. A posterior uterine tear arising from the cervix and spiraling up the posterior aspect of the uterus was discovered and repaired. because such uterine tears are rare in nulliparous women without prolonged labour or syntocinon use, a causal relationship with the use of misoprostol must be considered."

 

 

 

And:

 

 

"In a subsequent abstract (Merrell 1996), they described labour inductions with vaginal misoprostol in 345 women with live fetuses and 86 with intrauterine deaths. There was one unexplained maternal death; two uterine ruptures, one of which followed a previous caesarean section; eight caesarean sections for fetal distress and one for uterine hyperstimulation; and 10 perinatal deaths."

 

 

See More: Vaginal misoprostol for cervical ripening and induction of labour - Cochrane 2010 http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000941.pub2/full 

 

Matter of Public Interest

 

The Rotunda made significant efforts to conceal the circumstances in this case and the initial request into an inquest into Bimbo's death was denied. It was only after constant pressure and support from whistleblowers, advocacy groups, politician Clare Daly who put forward the PQs, and Bimbo's amazing and strong family that the coroner granted an inquest and the lithany of errors and failures of basic clinical care contributing to the circumstances surrounding Bimbo's death began to emerge. It is a matter of public interest that the details of these circumstances are acknowledged.

AIMSI is currently finalizing a catalogue of these errors to be published later today.

 

 

 References:

RTE News: Medical misadventure ruling at Onanuga inquest http://www.rte.ie/news/2013/1105/484745-inquest-bimbo-onanuga/

November 5, 2013 - Coroner rules Bimbo Onanuga (pictured above) died by 'medical misadventure'

Is induction of labour with Cytotec (Misoprostol) worth the risk? 

AIMS Ireland welcomes the verdict of ‘medical misadventure’ delivered in the Dublin Coroner’s Court in the case of Bimbo Onanuga, who died in the Rotunda Maternity Hospital in March 2010. The term ‘medical misadventure’ means that Bimbo Onanuga died of “an unintended result of an intended action” (RTE TV News, November 5, 2013). The Coroner welcomed changes in practice that had taken place in the Rotunda since Bimbo’s death but he also questioned various medical witnesses on the drug Cytotec (Misoprostol) and its off label use for induction of labour. While the administration of Cytotec will not be recorded as a cause of death in the case of Bimbo - or any other woman or baby who dies after being exposed to this 'off label' drug - it is still worthy of note that the Coroner's inquest focused on its use for induction of labour in Ireland and questioned the safety and efficacy of its 'off label' use.

Cytotec (Misoprostol) is a drug that is indicated for use in reducing gastric ulcers. It also has the side effect of producing uterine contractions and after it was approved by the FDA in the USA, it began to be used ‘off label’ for induction of labour in maternity services. This ‘off label’ use of approved medications is supported by the FDA and other similar medicines agencies worldwide as long as this use is based on sound medical evidence. 

A Cochrane review in 2010 of ‘Vaginal Misoprostol for cervical ripening and induction of labour’ raised serious questions about the evidence that supports ‘off label’ use of misoprostol. This review posits that what is of particular concern in the ‘off label’ use of misoprostol are “several reports of uterine rupture following misoprostol labour induction with and without previous caesarean section”. It also suggests that “in countries in which misoprostol is being used for non-registered obstetric indications, there is a need for health authorities and professional organisations to clarify the medico-legal implications”. In other words, it is of great importance that health authorities, such as the HSE. publish clear guidelines for practitioners to ensure the safety of a drug - particularly one that lacks well designed clinical trials that support efficacy and safety of use. 

In an article called The Freedom to Birth - The Use of Cytotec to Induce Labour: A Non-Evidence Based Intervention published in the Journal of Perinatal Education (2009) the author, Madeline Oden, discusses the need to be aware of the evidence-based interventions that are used in childbirth. The American College of Obstetricians and Gynecologists (ACOG) makes recommendations that have become the standard of care for labor and birth and Oden expalins that these recommendations sometimes deviate from the evidence-based ones supported by published research. The routine practices of episiotomies, induction, and denying food to the mother during labor without true medical indication have all been shown to be unnecessary interventions and can contribute to a spiraling effect of adverse events up to and including deaths of the mothers and/or infants. The off-label use of Cytotec (misoprostol) to induce labor and soften the cervix is an excellent example of an unnecessary intervention that is not supported by research (Enkin et al., 2000) (see Table) yet is rapidly becoming the standard of care, despite the evidence demonstrating the catastrophic events that can occur when it is used.

A Mother’s story - Madeline Oden discusses her experience of Cytotec

In December 2001, my 32-year-old daughter, Tatia Oden French, entered a well-known hospital in Oakland, California, to have her first child. She was in perfect health. The baby was in perfect health. The pregnancy was “unremarkable.” Tatia was almost 2 weeks past the due date, and the doctor wanted to induce her. After much stalling on Tatia's part, she reluctantly agreed to submit to induction. The agent used was Cytotec (misoprostol). None of the medical staff told us anything about Cytotec. When I asked what Cytotec was, I was told it is “the standard of care… we use it all the time.” Tatia said it was “not approved by the FDA [U.S. Food and Drug Administration] for use in labor.” Nothing else was said about the potential side effects, the dangers to the mom and child, or the alternatives. However, phrases such as “You don't want to go home with a dead baby, do you?” were said. The pressure was on. Tatia conceded. She told me to go home and that she would call me, believing it would be a long night. We told each other we loved each other and, having not decided on which specialty she would focus on in medical school, she smiled and said, “Maybe I'll be an OB/GYN.”

Ten hours after Tatia was induced with Cytotec, both she and her baby girl, Zorah, were dead. When I asked Tatia's doctor what happened, she just said, “It was a very rare adverse effect of Cytotec, but it does happen.” Still not comprehending what had just happened, I heard myself ask the doctor, “Could you at least tell me that you will not use that drug again?” Surprised, she looked at me and said, “No, I cannot promise that.” Finally, my two sons, Tatia's dad, Tatia's husband, and I were allowed into the operating room where Tatia and Zorah were lying perfectly still. We gathered and said a prayer around both of them. When I left the hospital, it was raining and gray and cold. I heard myself say out loud, “That drug is going to go away.”

After her daughter’s untimely death, Madeline Oden began to campaign for the cessation of the use of Cytotec for the induction of labour. She founded the Tatia Oden French Memorial Foundation in an effort to empower women around the issues of childbirth and pregnancy. The main focus of the foundation is on maternal mortality, ‘off label’ use of drugs, such as Cytotec, and informed consent. The danger of using a drug like Cytotec as an ‘off label’ medication is that no accurate statistics are kept on adverse events when it is used to induce labor. Oden says: “Pregnant women are still being given Cytotec, and some come through unscathed. However, many women and babies are permanently harmed.”

For more information about The Tatia Oden French Memorial Foundation, log on to the organization's Web site (http://www.tatia.org/)

For more information on Bimbo Onanuga and the AIMSI campaign to have her case heard at the Coroner’s Court, see http://nocountryforpregnantwomen.blogspot.ie/2013/11/inquest-into-death-of-bimbo-onanuga.html