AIMS Ireland are very surprised to see the HSE state that there are no national or international evidence based guidelines on the use of synthetic oxytocin in labour.
"A spokesperson for the HSE, which jointly operates the National Clinical Programme for Obstetrics and Gynaecology with the RCPI, told MI: “At present, we are not aware of any national or international guidelines to guide practice on oxytocin augmentation in labour. The programme supports the development and use of local guidelines at each maternity unit, but the programme hopes to build a national consensus on a standardised guideline over the next year.” Medical Independent - December 18, 2014
The comment comes from an article
on surveys taken by the States Claims Agency to the 19 Irish public maternity hospitals on the use of synthetic oxytocin in labour following observations that there is a frequency in obstetric claims when the drug is used, suggesting synthetic oxytocin to be a contributing factor.
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. With some Irish units reporting use of synthetic oxytocin in nearly half of first time mothers during labour, AIMS Ireland are deeply concerned that our national policy makers within the Health Service Executive appear to be unaware of clinical practice guidelines on its use.
In August 2013, AIMS Ireland reviewed the evidence and international guidelines for induction of labour and the use of synthetic oxytocin for the article "Induction of Labour - Is it Right for You?" as part of our 42 Weeks Campaign.
AIMS Ireland: Induction of Labour - Is it Right for You?
"A hormone drip containing synthetic oxytocin (Syntocinon®) should only be offered if the membrane sweep or prostaglandins have not been effective in starting labour. It is also offered to women who may have been induced by membrane sweep or prostaglandins but whose contractions and cervical dilation have slowed completely or appear to have stopped. It is not recommended for use until at least 6 hours after receiving prostaglandin gel or 12 hours after removal of the prostaglandin pessary. Whether to consent to induction of labour, or not, is a choice that at least 1 out of 3 women will have to make in her maternity care in Ireland."http://aimsireland.ie/induction-of-labour-is-it-right-for-you/
AIMS Ireland felt it would be helpful to provide a synopsis of these practice guidelines from well respected sources.
International Guidelines on Induction and the Use of Synthetic Oxytocin
“The National Institute for Health and Care Excellence (NICE) in the UK recommends that induction of labour has a large impact on the health of women and their babies, and so needs to be clearly clinically justified."
NICE Guidance Recommendations 2014: Intrapartum Care
https://www.nice.org.uk/guidance/cg190/chapter/1-recommendations
Key points: quoted directly from NICE
1.12.1 Do not offer or advise clinical intervention if labour is progressing normally and the woman and baby are well.
[2007]
1.12.2 In all stages of labour, women who have left the normal care pathway because of the development of complications can return to it if/when the complication is resolved. [2007]
1.12.10 Do not routinely offer the package known as active management of labour (one‑to‑one continuous support; strict definition of established labour; early routine amniotomy; routine 2‑hourly vaginal examination; oxytocin if labour becomes slow). [2007]
1.12.12 Do not use combined early amniotomy with use of oxytocin routinely.
[2007]
1.12.13 If delay in the established first stage is suspected, take the following into account:
- parity
- cervical dilatation and rate of change
- uterine contractions
- station and position of presenting part
- the woman's emotional state
- referral to the appropriate healthcare professional.
Offer the woman support, hydration, and appropriate and effective pain relief. [2007]
1.12.14 If delay in the established first stage is suspected, assess all aspects of progress in labour when diagnosing delay, including:
- cervical dilatation of less than 2 cm in 4 hours for first labours
- cervical dilatation of less than 2 cm in 4 hours or a slowing in the progress of labour for second or subsequent labours
- descent and rotation of the baby's head
- changes in the strength, duration and frequency of uterine contractions. [2007
1.12.22 If oxytocin is used, ensure that the time between increments of the dose is no more frequent than every 30 minutes. Increase oxytocin until there are 4–5 contractions in 10 minutes. (See also recommendation 1.10.3.) [2007]
1.10.35 If there are any concerns about the baby's wellbeing, think about the possible underlying causes and start one or more of the following conservative measures based on an assessment of the most likely cause(s):
- encourage the woman to mobilise or adopt a left‑lateral position, and in particular to avoid being supine
- offer oral or intravenous fluids
- offer paracetamol if the woman has a raised temperature
- reduce contraction frequency by:
- stopping oxytocin if it is being used (the consultant obstetrician should decide whether and when to restart oxytocin) and/or
- offering a tocolytic drug (a suggested regimen is subcutaneous terbutaline 0.25 mg). [new 2014]
WHO: recommendations for induction of labour
http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/9789241501156/en/
Key Points: Quoted directly fromWHO
* Induction of labour should be performed only when there is a clear medical indication for it and the expected benefits outweigh its potential harms.
* In applying the recommendations, consideration must be given to the actual condition, wishes and preferences of each woman, with emphasis being placed on cervical status, the specific method of induction of labour and associated conditions such as parity and rupture of membranes.
* Induction of labour should be performed with caution since the procedure carries the risk of uterine hyperstimulation and rupture and fetal distress.
WHO evidence:
Evidence related to the use of intravenous oxytocin for induction of labour at term was available from a Cochrane systematic review (15). Compared with placebo or expectant management, the use of oxytocin alone was associated with fewer vaginal births not achieved within 24 hours of induction of labour (three trials, 399 participants, RR 0.16, 95% CI 0.1–0.25), fewer admissions to a neonatal intensive care unit (seven trials, 4387 participants, RR 0.79, 95% CI 0.68–0.92), and increased risk of caesarean section (24 trials, 6620 participants, RR 1.17, 95% CI 1.01–1.35) (EB Table 2.1.1).
The use of intravenous oxytocin alone has also been compared with prostaglandins (EB Tables 2.1.2, 2.1.3, 2.1.4). Overall, the use of prostaglandins was associated with a reduced risk of vaginal birth not achieved within 24 hours and fewer caesarean births.
ACOG Induction Guidelines revised in 2013
From ACOG press release: "A physician capable of performing a cesarean should be readily available any time induction is used in the event that the induction isn't successful in producing a vaginal delivery," notes Dr. Ramin. Although rare, there are potential complications with some methods of labor induction. "These guidelines will help physicians utilize the most appropriate method depending on the unique characteristics of the pregnant woman and her fetus."
Guideline on Induction: http://www.acog.org/About-ACOG/ACOG-Departments/Deliveries-Before-39-Weeks/ACOG-Clinical-Guidelines
2013 ACOG: Study Finds Adverse Effects of Pitocin (Synthetic Oxytocin) in Newborns:
“Induction and augmentation of labor with the hormone oxytocin may not be as safe for full-term newborns as previously believed, according to research presented today at the Annual Clinical Meeting of The American College of Obstetricians and Gynecologists. Researchers say this is the first study of its kind to present data on the adverse effects of Pitocin use on newborns...As a community of practitioners, we know the adverse effects of Pitocin from the maternal side,” Dr. Tsimis said, “but much less so from the neonatal side. These results suggest that Pitocin use is associated with adverse effects on neonatal outcomes. It underscores the importance of using valid medical indications when Pitocin is used.”
http://www.acog.org/About-ACOG/News-Room/News-Releases/2013/Study-Finds-Adverse-Effects-of-Pitocin-in-Newborns
ACOG: Oxytocin for Induction PDF:
"The side effects of oxytocin use are principally dose related; uterine tachysystole and Category II or III FHR tracings are the most common side effects. Uterine tachysystole may result in abruptio placentae or uterine rupture. Uterine rupture secondary to oxytocin use is rare even in parous women"
* Uterine Tachysystole is when a woman's uterus is over-stimulated resulting in more than the normal pattern of contractions in a period of 30 minutes.
"Low- or high-dose oxytocin regimens are appropriate for women in whom induction of labor is indicated"
"If uterine tachysystole with Category III FHR tracings occur, prompt evaluation is required and intravenous infusion of oxytocin should be decreased or discontinued correct the pattern (32). Additional measures may include turning the woman on her side and administering oxygen or more intravenous fluid. If uterine tachysystole persists, use of terbutaline or other tocolytics may be considered. Hypotension may occur following a rapid intravenous injection of oxytocin; therefore,
is imperative that a dilute oxytocin infusion be used even in the immediate puerperium."
"The use of a checklist is highly recommended when administering oxytocin. Checklists provide prerequisites at the point of patient care to safely initiate oxytocin and help to identify situations that
require its discontinuation. The Hospital Corporation of America (HCA) and the Institute of Healthcare Improvement (IHI) have developed oxytocin checklists that could be incorporated into your institution’s protocol."
So, with all this information available to consumers at just the click of a mouse how is it that the National Health Service Executive, with governance to make policies affecting the care of women and babies in our maternity services, are not?
Full Article: State Claims Agency surveys maternity services on oxytocin http://www.medicalindependent.ie/57516/state_claims_agency_surveys_maternity_services_on_oxytocin
