Strategies for intrapartum foetal surveillance in low- and middle-income countries: A systematic review

Background The majority of the five million perinatal deaths worldwide take place in low-resource settings. In contrast to high-resource settings, almost 50% of stillbirths occur intrapartum. The aim of this study was to synthesise available evidence of strategies for foetal surveillance in low-resource settings and associated neonatal and maternal outcomes, including barriers to their implementation. Methods and findings The review was registered with Prospero (CRD42016038679). Five databases were searched up to May 1st, 2016 for studies related to intrapartum foetal monitoring strategies and neonatal outcomes in low-resource settings. Two authors extracted data and assessed the risk of bias for each study. The outcomes were narratively synthesised. Strengths, weaknesses, opportunities and threats analysis (SWOT) was conducted for each monitoring technique to analyse their implementation. There were 37 studies included: five intervention and 32 observational studies. Use of the partograph improved perinatal outcomes. Intermittent auscultation with Pinard was associated with lowest rates of caesarean sections (10–15%) but with comparable perinatal outcomes to hand-held Doppler and Cardiotocography (CTG). CTG was associated with the highest rates of caesarean sections (28–34%) without proven benefits for perinatal outcome. Several tests on admission (admission tests) and adjunctive tests including foetal stimulation tests improved the accuracy of foetal heart rate monitoring in predicting adverse perinatal outcomes. Conclusions From the available evidence, the partograph is associated with improved perinatal outcomes and is recommended for use with intermittent auscultation for intrapartum monitoring in low resource settings. CTG is associated with higher caesarean section rates without proven benefits for perinatal outcomes, and should not be recommended in low-resource settings. High-quality evidence considering implementation barriers and enablers is needed to determine the optimal foetal monitoring strategy in low-resource settings.


Blinding of participants, personnel and outcome assessors Assessments should be made for each main outcome (or class of outcomes)
Describe all measures used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Was knowledge of the allocated intervention adequately prevented during the study?

Incomplete outcome data Assessments should be made for each main outcome (or class of outcomes)
Describe the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
Were incomplete outcome data adequately addressed?

Selective outcome reporting
State how the possibility of selective outcome reporting was examined by the review authors, and what was found.
Are reports of the study free of suggestion of selective outcome reporting?

Other sources of bias
State any important concerns about bias not addressed in the other domains in the tool.
If particular questions/entries were pre-specified in the review's protocol, responses should be provided for each question/entry.
Was the study apparently free of other problems that could put it at a high risk of bias?

Possible approach for summary assessments outcome (across domains) within and across studies Risk of bias Interpretation Within a study Across studies
Low risk of bias Plausible bias unlikely to seriously alter the results.
Low risk of bias for all key domains. Most information is from studies at low risk of bias.
Unclear risk of bias Plausible bias that raises some doubt about the results Unclear risk of bias for one or more key domains.
Most information is from studies at low or unclear risk of bias.
High risk of bias Plausible bias that seriously weakens confidence in the results.
High risk of bias for one or more key domains.
The proportion of information from studies at high risk of bias is sufficient to affect the interpretation of the results.

SEQUENCE GENERATION Was the allocation sequence adequately generated? [Short form: Adequate sequence generation?]
Criteria for a judgement of 'YES' (i.e. low risk of bias).
The investigators describe a random component in the sequence generation process such as: Referring to a random number table; Using a computer random number generator; Coin tossing; Shuffling cards or envelopes; Throwing dice; Drawing of lots; Minimization*. *Minimization may be implemented without a random element, and this is considered to be equivalent to being random.
Criteria for the judgement of 'NO' (i.e. high risk of bias).
The investigators describe a non-random component in the sequence generation process. Usually, the description would involve some systematic, non-random approach, for example: Sequence generated by odd or even date of birth; Sequence generated by some rule based on date (or day) of admission; Sequence generated by some rule based on hospital or clinic record number. Other non-random approaches happen much less frequently than the systematic approaches mentioned above and tend to be obvious. They usually involve judgement or some method of non-random categorization of participants, for example: Allocation by judgement of the clinician; Allocation by preference of the participant; Allocation based on the results of a laboratory test or a series of tests; Allocation by availability of the intervention. Criteria for the judgement of 'UNCLEAR' (uncertain risk of bias).
Insufficient information about the sequence generation process to permit judgement of 'Yes' or 'No'.

ALLOCATION CONCEALMENT Was allocation adequately concealed? [Short form: Allocation concealment?]
Criteria for a judgement of 'YES' (i.e. low risk of bias).
Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: Central allocation (including telephone, web-based, and pharmacy-controlled, randomization); Sequentially numbered drug containers of identical appearance; Sequentially numbered, opaque, sealed envelopes. Criteria for the judgement of 'NO' (i.e. high risk of bias).

Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on:
Using an open random allocation schedule (e.g. a list of random numbers); Assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non-opaque or not sequentially numbered); Alternation or rotation; Date of birth; Case record number; Any other explicitly unconcealed procedure.
Criteria for the judgement of 'UNCLEAR' (uncertain risk of bias).
Insufficient information to permit judgement of 'Yes' or 'No'. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement -for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed.

BLINDING OF PARTICIPANTS, PERSONNEL AND OUTCOME ASSESSORS Was knowledge of the allocated interventions adequately prevented during the study? [Short form: Blinding?]
Criteria for a judgement of 'YES' (i.e. low risk of bias).
Any one of the following: No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be influenced by lack of blinding; Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken; Either participants or some key study personnel were not blinded, but outcome assessment was blinded and the nonblinding of others unlikely to introduce bias.
Criteria for the judgement of 'NO' (i.e. high risk of bias).
Any one of the following: No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding; Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken; Either participants or some key study personnel were not blinded, and the non-blinding of others likely to introduce bias.
Criteria for the judgement of 'UNCLEAR' (uncertain risk of bias).
Any one of the following: Insufficient information to permit judgement of 'Yes' or 'No'; The study did not address this outcome.

INCOMPLETE OUTCOME DATA Were incomplete outcome data adequately addressed? [Short form: Incomplete outcome data addressed?]
Criteria for a judgement of 'YES' (i.e. low risk of bias).
Any one of the following: No missing outcome data; Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias); Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups; For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate; For continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size; Missing data have been imputed using appropriate methods. Criteria for the judgement of 'NO' (i.e. high risk of bias).
Any one of the following: Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups; For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate; For continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size; 'As-treated' analysis done with substantial departure of the intervention received from that assigned at randomization; Potentially inappropriate application of simple imputation.
Criteria for the judgement of 'UNCLEAR' (uncertain risk of bias).
Any one of the following: Insufficient reporting of attrition/exclusions to permit judgement of 'Yes' or 'No' (e.g. number randomized not stated, no reasons for missing data provided); The study did not address this outcome.