Evidence
Overview of 2018 surveillance methods
Overview of 2018 surveillance methods
NICE's surveillance team checked whether recommendations in intrapartum care for healthy women and babies (NICE guideline CG190) remain up to date.
The surveillance process consisted of:
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Feedback from topic experts via a questionnaire.
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A search for new or updated Cochrane reviews and national policy.
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Examining related NICE guidance and quality standards and NIHR signals.
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A search for ongoing research.
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Examining the NICE event tracker for relevant ongoing and published events.
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Literature searches to identify relevant evidence.
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Assessing the new evidence against current recommendations to determine whether or not to update sections of the guideline, or the whole guideline.
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Consulting on the decision with stakeholders, except if we propose to update and replace the whole guideline.
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Considering comments received during consultation and making any necessary changes to the proposal.
For further details about the process and the possible update decisions that are available, see ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual.
Evidence considered in surveillance
Search and selection strategy
We searched for new evidence related to the whole guideline.
We found 104 studies in a search for randomised controlled trials, systematic reviews and qualitative studies published between 10 February 2014 and 3 October 2018.
We also included 4 studies identified in comments received during consultation on the 2019 surveillance review.
From all sources, we considered 108 studies to be relevant to the guideline.
See appendix A for details of all evidence considered, and references.
Selecting relevant studies
Due to the large number of studies identified in the initial search, the following strategies were taken to ensure only relevant studies were selected:
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Any evidence originating from non-OECD countries were excluded unless they were deemed to be applicable to a UK setting.
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For evidence relating to pain relief interventions, studies were only included if they reported pain score items.
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Single studies already taken into account in a Cochrane review were excluded.
Ongoing research
We checked for relevant ongoing research; of the ongoing studies identified, 5 studies were assessed as having the potential to change recommendations; therefore we plan to check the publication status regularly, and evaluate the impact of the results on current recommendations as quickly as possible. These studies are:
Intelligence gathered during surveillance
Views of topic experts
We considered the views of topic experts, including those who helped to develop the guideline. For this surveillance review, topic experts completed a questionnaire about developments in evidence, policy and services related to the NICE guideline.
We sent questionnaires to 16 topic experts and received 4 responses. The topic experts were recruited to the NICE Centre for Guidelines Expert Advisers Panel to represent their specialty.
Two of the experts felt that the guideline is in need of update, whereas 2 did not. Areas identified for update included the cardiotocography (CTG) classification tables and definitions of normal progression of labour. One expert highlighted that the CTG classification tables in the NICE guideline may be too complicated for use and those provided by the International Federation of Gynaecology and Obstetrics (FIGO) are preferred by clinicians. The expert called for the tables in the NICE guideline to be simplified, highlighting that CTG misinterpretation is a large factor in intrapartum care problems. In light of these concerns and to reduce the risk of CTG misinterpretation, we will amend the tables accordingly (see editorial and factual inaccuracies).
The new evidence highlighted by topic experts around progression of normal birth was not in scope for the guideline as it was related to induction of labour and caesarean section.
Other sources of information
We considered all other correspondence received since the guideline was published. The National Maternity Review published a report on Better Births in February 2016 which was considered in this surveillance review. It contains recommendations to improve outcomes for maternity services and has led to the launch of the government's Maternity Transformation Programme which is currently underway in the NHS. We reviewed the report against the guideline recommendations and decided no impact is expected.
Views of stakeholders
Stakeholders are consulted on all surveillance reviews except if the whole guideline will be updated and replaced. Because this surveillance proposal was to update part of the guideline, we consulted with stakeholders.
Overall, 23 stakeholders commented: 5 represented charitable organisations, 5 represented trusts, 2 were commercial organisations, 1 was a government organisation, 5 were royal colleges, 2 were universities and 3 were professional bodies. Twenty stakeholders agreed with the decision to update the guideline and 3 did not state a response. Due to the large number of responses, only the main themes are summarised below. See appendix B for full details of stakeholders' comments and our responses.
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Intravenous oxytocin: a large number of stakeholders raised a concern about the practicalities of delivering intravenous oxytocin during active management of the third stage of labour. They highlighted that this delivery method is not suitable across all birth settings, particularly for home births and midwife-led units. We have acknowledged this concern and note that the applicability of the new evidence may be limited to births in obstetric units. We will pass on the comments to the developers for consideration during the guideline update.
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CTG classification table: many stakeholders were in agreement with the topic experts in the concerns raised around the usability of these tables. They agreed that the tables are too complicated for use and many use the equivalent information from the tables in FIGO guidance. In light of these concerns and to reduce the risk of CTG misinterpretation, we will amend the tables accordingly (see editorial and factorial inaccuracies).
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Uterotonic drugs: 2 stakeholders highlighted the emerging evidence on carbetocin as a replacement for oxytocin during active management of the third stage of labour, due to its temperature stable properties. An updated Cochrane review and a randomised controlled trial published after the literature search cut-off dates were highlighted and have been considered in this surveillance review (see appendix A for a summary of the findings). The new evidence indicates that carbetocin may be comparable to oxytocin in the prevention of postpartum haemorrhage, both in terms of clinical effectiveness and in minimal side effects. However, there is still some uncertainty in the evidence and we anticipate that an ongoing trial (IMox) in this area will provide more clarity. We are monitoring the progress of this trial and will consider the impact on recommendations when the results are available.
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Pushing in the second stage: we asked stakeholders for feedback on adherence to recommendation 1.9.9 in the guideline which advises that pushing should be delayed for at least 1 hour in women with regional analgesia, upon confirmation of full cervical dilation. We asked this to help interpret the impact of a new trial comparing the effect of immediate and delayed pushing during the second stage of labour on spontaneous vaginal birth. Results indicate that there were no differences between groups for rates of spontaneous vaginal delivery, neonatal morbidity or perineal lacerations. However, women who were instructed to push immediately had significantly lower rates of postpartum haemorrhage and shorter duration of the second stage. Eleven stakeholders responded to say that delayed pushing is standard practice in their organisation and they are not aware of any implementation issues with recommendation 1.9.9. After considering the new evidence, stakeholder feedback and after seeking further opinion from the topic experts, we have decided that the guideline will not be impacted at this point. Given that there are inconsistencies with previous studies, more research is required to confirm these findings and provide more evidence on the outcome of postpartum haemorrhage.
See ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual for more details on our consultation processes.
Editorial and factual inaccuracies
Editorial amendments
During surveillance of the guideline we identified the following points in the guideline that should be amended:
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The final bullet point in recommendation 1.10.15 which reads 'above 180 beats/minute', needs to be aligned with the previous bullet point as it is currently out of sync.
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Research recommendation 1 on models of midwifery-led care should be stood down. Continuity of care in maternity services is now a national policy in the UK following on from the National Maternity Review report Better Births and the subsequent Maternity Transformation Programme. It is no longer necessary to have a research recommendation in this area.
Refresh of recommendations
An amendment to tables 10 and 11 in the section on monitoring during labour is required. Feedback from topic experts and stakeholders indicated that the table contents are difficult to interpret and may be causing errors in practice. They advised that the tables provided in other national guidance are more user-friendly. In light of these concerns and to reduce the risk of CTG misinterpretation, we will amend the tables accordingly.
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