Wednesday, 6 November 2013

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.”

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.”

RCPI Guidelines

Royal College of Physicians I reland (RCPI) Guideline: #4 Intrapartum fetal heart rate monitoring - Appendix 4:

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:

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."

"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 
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.



RTE News: Medical misadventure ruling at Onanuga inquest

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