The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Insertion of a double balloon catheter for induction of labour in pregnant women without previous caesarean section, in July 2015.
Induction of labour is the most commonly performed obstetric intervention. It occurs in up to 20% of pregnancies in the UK and is generally carried out when the risks of continuing pregnancy outweigh the benefits. It is usually more painful than spontaneous labour, and epidural analgesia and assisted delivery are more likely to be needed.
Maternal and fetal indications for induction of labour include pregnancy-induced hypertensive disorders, diabetes, post-term pregnancy, estimated large-for-date fetus, thrombophilia, intra-uterine fetal growth restriction, oligohydramnios, non-reassuring fetal status and fetal death.
Various methods are used to ripen and dilate the cervix and successfully induce labour in women when the cervix is unfavourable for induction. These include pharmacological methods (prostaglandins in the form of vaginal gels or tablets, or pessaries, and oxytocin as a slow intravenous infusion), surgical methods (amniotomy, alone or with oxytocin) and mechanical methods (laminaria tents and balloon catheters introduced through the cervix into the cervical canal and the extra-amniotic space).
The aim of mechanical interventions is to ripen and dilate the cervix and promote onset of labour by applying pressure on the internal cervical os by indirectly increasing local secretion of prostaglandins and oxytocin, or both. Also, mechanisms which involve neuroendocrine reflexes may promote the onset of uterine contractions. A standard Foley urinary catheter is commonly used, with the balloon inflated in the extra-amniotic space and the catheter then put under tension to pull back against the cervical os.
Sometimes saline solution is also infused in the extra-amniotic space as an adjunct.
The OPCS-4 codes for Insertion of a double balloon catheter for induction of labour in pregnant women without previous caesarean section are:
R15.8 Other specified other induction of labour.
The Clinical Classifications Service has advised NICE that currently these are the most suitable OPCS-4 codes to describe this procedure. The OPCS-4 classification is designed to categorise procedures for analysis and it is not always possible to identify a procedure uniquely.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.