Electronic intrapartum fetal monitoring: a systematic review of international clinical practice guidelines

BACKGROUND Electronic fetal monitoring or fetal assessment using a cardiotocograph is currently the most commonly employed tool for intrapartum surveillance. Furthermore, there are numerous guidelines informing best practice worldwide. OBJECTIVE This systematic review aimed to compare and appraise all available practice guidelines on intrapartum electronic fetal monitoring to describe the similarities and variations in recommendations. STUDY DESIGN A systematic protocol was developed per Preferred Reporting Item for Systematic Review and Meta-Analysis Protocols. A total of 4 independent reviewers were involved with independent searches and quality assessment using the Appraisal of Guidelines for Research and Evaluation Instrument for guideline quality reporting. RESULTS Overall, 7 international practice guidelines were included in this systematic review. Appraisal of Guidelines for Research and Evaluation Instrument showed higher scores for scope and purpose and for clarity of presentation; however, the overall assessment varied between 25% and 89%. When individual characteristics of electronic fetal monitoring or cardiotocograph were compared, all guidelines and guidance were essentially trying to describe the characters similarly, with critical differences described in the full article. CONCLUSION In the context of globalization, a uniform approach for defining terminology, classifying characters and similar interpretation of results is needed for electronic fetal monitoring. Therefore, we should consider a unified, simple, logistically approved, and acceptable guideline, which is probably accepted worldwide.


Introduction
Electronic fetal monitoring (EFM) or cardiotocography (CTG) is the current mainstay of intrapartum fetal monitoring worldwide. At its inception, there were no objective data or evidence to support its use, and there was certainly no randomized trial. A recent systematic review 1 concluded that the use of CTG or EFM made no difference to clinical outcomes, such as cesarean delivery or instrumental deliveries. Several guidelines have been developed by institutions or international bodies to govern practice in several hospitals. Although there are agreements with these guidelines, there are also differences and variations. For example, fetal heart tracing is classified as "abnormal" attribute variations. 2,3 CTG or EFM has significant interobserver variability in interpretation. 4 Particularly, the American College of Obstetricians and Gynecologists (ACOG) guideline shows the highest interobserver agreement for category II tracings and the lowest interobserver agreement for category I and III tracings. In addition, the variations for the prediction of acidemia varies between the ACOG and International Federation of Gynecology and Obstetrics (FIGO) guidelines. Furthermore, there were low but fair interobserver variations when comparing the French guideline with the FIGO guideline. The choice between these guidelines could have an impact on first cesarean delivery decision. 5 Data from the last 60 minutes before delivery have shown that it is difficult to accurately estimate fetal acidemia. 6 This could be related to (1) the inter-and intraobserver differences in interpretation of EFM of CTG, (2) the actual definition of fetal heart rate features used for the interpretation, and (3) a sustained, systematic error in the build of all guidelines across CTG or EFM. Consequently, there have been attempts to move away from pattern recognition to physiological approach at CTG interpretation, possibly trying to reduce the variations. 7 It is more likely that the use of additional high-tech advances, such as remote wearable technology 8 and computer-analyzed technologies 9 and artificial intelligence, may likely replace the human interphase or interpretation for investigations, such as CTG or EFM. However, not having a defined or common agreement is likely to compromise this future perspective for any progress in EFM.
In summary, several guidelines are used worldwide with a background understanding of interobserver variance and observed variations, such as prediction of acidemia among international practice guidelines. Newer technologies are arising with the use of these basic principles. Considering all these factors together, there is currently no study available to compare all the international practice guidelines to understand the commonalities and differences and to improve the further standard of care. Therefore, we presented a systematic review of CTG or EFM guidelines, explicitly looking at recommendations that are particularly focused on how to describe CTG or EFM.

Methods Sources
A priori protocol was defined per Preferred Reporting Item for Systematic Review and Meta-Analysis Protocols (PRISMA-P), 10 which included defined objectives, criteria for guideline selection, and approach to assessing outcomes. All reviewers had undertaken relevant training on Appraisal of Guidelines for Research and Evaluation (AGREE) on the AGREE Enterprise website 11 and had previous experience in local and international guideline appraisals. The protocol developed was registered on the International Prospective Register of Systematic Reviews (CRD42018085085). The review was reported in accordance with the PRISMA statement. 12 The initial literature search was performed on June 27, 2019, by M.M. and J.R. and repeated by our librarian A.P., and the search was further updated on July 19, 2020, and the contents of the publication updated with the final revised search. Electronic databases included in the searches were PubMed, Embase, Cochrane Central Register of Controlled Trials, Scopus, and Web of Science. Furthermore, hand search was performed. The search words included electronic fetal monitoring, cardiotocography, pregnancy, obstetrics, and labo*. In addition, we specifically searched for clinical practice guideline-producing bodies, including the National Guideline Clearinghouse, the National Institute for Health and Care Excellence, FIGO, the Scottish Intercollegiate Guidelines Network, the ACOG, the Royal College of Obstetricians and Gynaecologists, the Society of Obstetricians and Gynaecologists of Canada, the German Society of Gynecology and Obstetrics, and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Other international bodies, including the World Health Organization and international societies of obstetrics and gynecology from Belgium, France, and the rest of the world, were also searched to completely include all internationally developed and organizationally affiliated accepted practice guidelines (Figure).

Guideline selection
All titles and abstracts were screened on the basis of the selection criteria by M.M. and J.R. independently to select the relevant guidelines per the protocol. Furthermore, all titles and abstracts were rescreened and compared for validity by G.L. and P.J. independently. For uncertain titles and abstracts, a group consensus was obtained. All 4 primary reviewers independently screened the full contents of the selected guidelines and then assessed them using the AGREE II platform electronically to collate the published results. The AGREE II scoring by independent reviewers only had minor expected variations, which was summated using the AGREE II software, and therefore did not have any major discrepancy.

Selection criteria
Inclusion. Published clinical practice guidelines of national or international bodies were included if the (1) recommended guidelines included the mode of identifying all features of EFM or CTG and provided a recommendation or actions necessary to manage the identified features appropriately and (2) if the recommendation could be part of an independent EFM or CTG intrapartum guideline or could be part of the main guideline of pregnancy, which includes intrapartum care with EFM or CTG.
Exclusion. The following guidelines were excluded from the review: 1. Regional or institutional guidelines 2. Guidelines more than 15 years old with current or updated versions 3. Scientific papers, including committee opinions, scientific impact

AJOG MFM at a Glance
Why was this study conducted?
To study the variations and similarities of international practice guidelines on electronic intrapartum fetal monitoring.
Key findings All guidelines are essentially trying to describe the characteristics similarly with some essential variations identified and described.
What does this add to what is known?
The pieces of information for future guideline developments regarding a unified global approach for interpreting and standardizing electronic intrapartum monitoring. ajog.org Original Research 6. Recommendation on intrapartum fetal blood sampling In addition, general characteristics, including the status of publication, type of organization, and type or grade of recommendations, were examined. Furthermore, 2 guidelines were excludeda Japanese guideline 13 because it was based on fetal heart rate pattern only and therefore could not be compared with other guidelines and a Polish guideline 14 because it was as an adaptation of the ACOG guideline (it was excluded to avoid duplication).

Quality assessment
A total of 4 reviewers (M.M., J.R., G.L., and P.J.) underwent and completed appropriate training in the use of the quality assessment instrument (AGREE II) and then used the instrument independently. 11 The distribution and collation were performed by M.M. and were reviewed by S.L. Each of the 23 items in all 6 domains was assessed on a 7-point scale. A score of 7 indicated exceptional quality reporting and that all the criteria and considerations articulated by AGREE II were met. A score of 1 indicated an absence of information or that the concept is poorly reported. A score between 6 and 2 indicated that the quality of reporting did not fully or only partially complied with AGREE II. The percentage of the maximum score in each domain was calculated. The final score calculated by M.M. and reviewed by S.L. was then agreed for consensus by all authors.

Results
This systematic review using AGREE II included 7 guidelines 2,3,15−19 published from 2007 to 2020, and 5 of these guidelines have been recently updated. 2,3,15 −17 The general characteristics of the guidelines are represented in Table 1.
We specifically looked into the recommendations per our inclusion criteria, and apart from fetal blood sampling, all guidelines had reported on all the other recommendations. The guideline recommendations are provided in Table 2.
The AGREE II scores showed similarities and variations in each guideline or guidance produced. The scope and purpose (63%−97%) of the guidelines and presentation clarity (60%−91%) were high. However, the overall assessment varied between 25% and 89%, and the variation was predominantly because of the lack of information in the published guidelines with respect to rigor development (28%−90%) and editorial independence (19%−67%) ( Table 3).

Discussion
This systematic review showed much higher scores for the scope and purpose of the 7 guidelines, suggesting that most developments of guidelines focused on the overall objectives of the guidelines. The guidelines specifically describe health questions, such as the need for CTG or EFM in clinical practice. The clarity of presentation is specific and unambiguous, and all guidelines provide key recommendations for clinical practice, which are highlighted in the guidelines and easy to follow.
The overall assessment varied between 25% and 89%, predominantly because of the unavailability of information per AGREE II. Most information could not be extracted from the published guidelines, some of which included the systematic search methods not described, the criteria for selecting evidence not described in the guideline, and the strength and limitation of evidence not well described.
In addition, editorial independence varied (19%−67%) because some of the guidelines did not address the views of the funding body that influence the This study showed similarities and differences in various national and international guidelines in the interpretation of CTG (Tables 4−7).
The areas of dissimilarities where we believe there could be discussions on standardization included defining the baseline heart rate, bradycardia, and/or duration of prolonged bradycardia. There needs to be a unified approach, as these variations could be associated with neonatal outcomes secondary to nonstandardization.
There is a need to form a consensus about whether or not to include a sinusoidal pattern in the guidelines or whether the sinusoidal pattern belongs to the baseline rate or variability group. In addition, some guidelines describe prolonged deceleration in the baseline, whereas others do in the deceleration category. This may not necessarily affect the clinical management and outcome of the monitored neonates but may confuse those delivering clinical practice worldwide as to why the parameters are in different groups.
EFM or CTG is known to have an interobserver agreement but with variation, 4 and a Cochrane systematic review 1 showed that CTG monitoring in labor reduced the rate of neonatal seizures, with no clear difference in cerebral palsy, infant mortality, or neonatal well-being. However, CTG use was associated with increased maternal morbidity, including increased cesarean delivery interventions and instrumental deliveries. All of these anomalies could be related to variations in interpretation.
Single characters of EFM or CTG studied, such as the accepted baseline rate, have addressed differences in the baseline rates and suggested accepted standards. 20 Furthermore, we should objectively assess other EFM or CTG characters and whether they should be used in standard guidelines.       21,22 suggested that even the use of "decision support software" in intrapartum fetal monitoring played no role in outcomes compared with CTG alone. The study excluded the associated human factors in the study group and showed no difference in the outcome. This finding could be attributed to the fact that the clinical guidance on EFM or CTG monitoring contains some conflicting factors that might lead to different interpretations and therefore sometimes fail to identify when to deliver.
Therefore, this commonly used tool for intrapartum fetal monitoring needs much more rigorous testing to determine its diagnostic accuracy. There need to be accurately defined and unified standards. There is a requirement for more studies on individual components of EFM of CTG, for example, the baseline rate study. 20 Overall, CTG requires further study and analysis to fully understand how an accepted consensus guideline can be reached.
Based on these findings and implications, we would recommend a "world consensus CTG guideline." Representatives or groups with EFM or CTG expertise should be identified worldwide and brought together to construct a "consensus international guideline."

Conclusion
This study showed that the 7 international practice guidelines reviewed had very well-defined scopes describing their development and were presented very well with clarity. However, guideline development committees should also attempt to describe the rigorous development process, such as a summary on evidence search, criteria for selecting the obtained evidence, and the strengths and limitations. All these should be provided either in the guideline or as a supplement. The guideline development committee should always declare their conflict of interest to offer editorial independence and broader acceptance of understanding without any conflicts.
This study demonstrated that guidelines worldwide generally convey the same principles behind interpreting intrapartum EFM or CTG, but practice differences exist.
In the context of globalization, a uniform approach by all the guideline-producing bodies to provide a single, simple, logistically approvable guideline or a synchronous approach by international guideline-developing committees to work together to minimize variation is recommended. Using agreed terminology, in particular, there should be a consensus description of bradycardia and prolonged deceleration as these may affect the outcome of sentinel hypoxic events.
In addition, the deficiencies of EFM of CTG need more research along with consensus reporting or guideline approach worldwide. In the context of globalization, an internationally accepted unified guideline is a practical solution; however, this means that all guideline-producing bodies or societies need to think about how best to produce this. &