Critical signs and symptoms for self-assessment in the immediate postnatal period: an international Systematic Scoping Review and Delphi consensus study

doi:10.21203/rs.3.rs-4358269/v1

Background

Every 2 minutes a woman dies from complications of pregnancy and childbirth. Most maternal deaths occur within the first 24 hours following birth, highlighting the importance of immediate postnatal care (iPNC). Self-care strategies are increasingly being employed to promote women-centred, continuous care provision. Despite international calls for development of strategies promoting self-care, none have been developed for self-monitoring in the immediate postnatal period. Fundamental to the development of a self-monitoring strategy, is an understanding of which signs and symptoms are predictive of maternal morbidity and mortality and can be easily assessed by mothers and birth companions, in health facilities, without the need for equipment. The objective of this study was to develop and achieve international consensus on the key signs and symptoms.

Methods

A multi-step approach involving a systematic scoping review, two- round Delphi Survey, and expert consensus was employed to identify key signs and symptoms that can be self- assessed and predict morbidity and mortality in the immediate postnatal period.

Results

A comprehensive list of 351 key signs and symptoms was identified from 44 clinical practice guidelines. Subsequently, 134 signs and symptoms were reviewed by Delphi respondents and international expert consensus was achieved for 19 key signs and symptoms across seven condition categories. The signs that were considered both important and able to be self-assessed by mothers and birth companions in the first 24 hours following birth included change in consciousness, seizure, severe headache, persistent visual impairment, urinary incontinence, chest pain, shortness of breath, severe pallor, fast heartbeat, rejection of baby, suicidal/infanticidal, fever, heavy blood loss, soft flabby uterus, unable to urinate easily, foul smelling discharge, rigors, syncope/dizziness, abnormal coloured urine.

Conclusion

This study identified key signs and symptoms which can be easily assessed by mothers and birth companions in the immediate postnatal period to identify those most at risk of morbidity and mortality. Further work is needed to validate this screening tool, and adapt it for other regions and countries.

According to the latest United Nations (UN) estimates, a woman dies from complications of pregnancy and childbirth every two minutes.¹ Most maternal mortality occurs within the first 24 hours and a focus on immediate postnatal care (iPNC) is therefore important.^2,3

Despite its lifesaving value, postnatal care is critically neglected. One in five mothers and babies do not have access to life-saving postnatal care interventions.⁴ Furthermore, the COVID-19 pandemic resulted in increasing fragmentation and disruption of essential reproductive health services including postnatal care. There is an urgent need for new and innovative strategies for postnatal care to ensure the accelerated reduction in global maternal deaths needed to achieve the Sustainable Development Goal Target 3.1 by 2030.¹

Recent global crises have highlighted self-care strategies as effective mechanisms to ensure continued provision of services, promote women centred care and achieve universal health coverage. As such the World Health Organization (WHO) has made a call for strategies and interventions that promote self-care.⁵ Yet within the existing list of self-care interventions, there is a lack of strategies for self-monitoring in the immediate postnatal period by mothers, supported by their birth companions, in health facilities.⁶

Developing self-monitoring strategies requires an understanding of the key signs and symptoms and whether these could be easily assessed by mothers and birth companions in the immediate postnatal period. To date, there is no existing research nor consensus on this.

The objective of this study was to achieve international consensus on a list of key immediate postnatal signs and symptoms that are predictive of maternal morbidity and which mothers, or their birth companions could self-assess in health facilities during the immediate postnatal period, without the need for additional equipment.

A multi-step approach was utilised for this process including systematic scoping review, expert review and Delphi survey. (Table 1)

Table 1

Process for establishing content of the Immediate Postnatal Women’s Assessment (ImPoWA) tool
Step	Aims	Participants	Methods
1	Systematic scoping literature review to generate a comprehensive list of signs and symptoms that clinical practice guidelines suggest should be assessed in the immediate postnatal period	N/A	Systematic scoping literature review
2	Review of systematic scoping review findings to agree on the content validity of key signs and symptoms for inclusion in Delphi Survey	Expert Committee	Group Discussion
3	Rating of the importance of signs and symptoms, and suggestion of any new additions	Delphi respondents (identified through snowball sampling)	Delphi Survey
4	Repeat of step 3 with the refined list	Invitations to same Delphi respondents as in step 3 above	Delphi Survey
5	Review of unresolved signs and symptoms, and achieving final consensus on tool content.	Expert Committee	Group Discussion

Step 1: Systematic Scoping Review

A systematic scoping review was undertaken to identify a comprehensive list of signs and symptoms that international clinical practice guidelines (CPG’s) suggest should be assessed within the immediate postnatal period. The review question was broad and as such PROSPERO advised the authors to conduct a scoping review. That said, the authors were committed to conduct the review rigorously and adopt a systematic approach. As such, the review was also conducted in accordance with PRISMA guidelines.⁷

The most recent versions of CPGs, available in English and published between January 2010 and June 2020, were included. Guidelines were excluded that were not specific to postnatal mothers or did not specify signs or symptoms to be assessed during the postnatal period. Primary and secondary research studies, conference abstracts, locally created CPGs, or those focusing on COVID-19 were excluded.

A three-step search strategy was used (Appendix 1). Firstly, a comprehensive search of 15 published and three unpublished databases electronic databases was conducted. Secondly, a search of maternal health professional organisations and societies websites was conducted. Thirdly, the reference lists of selected guidelines were reviewed to identify additional CPGs.

Title and abstract screening was conducted by one reviewer (NB). Full text screening was conducted by two reviewers (TD, NB), with a third reviewer (ADW) available to discuss any disagreements. Data was extracted by TD and NB in duplicate to a pre-created data extraction form. Signs and symptoms were transcribed literally before being organised into categories according to the clinical condition they related to, based on clinical opinion. Any duplicated signs or symptoms were removed at this stage.

The quality of included CPGs was assessed by two reviewers (TD, NB) using the AGREE II tool with a third reviewer (ADW) consulted to discuss discrepancies. ⁸ In line with previous literature, a score of > 60% for each domain was considered sufficient.^8–10 Finally, two reviewers (TD, NB) provided an overall assessment of each guideline, using the following parameters:

‘Recommended’ was assigned if most domains (four or more) scored above 60%.

‘Recommended with modifications’ was assigned if most domains (four or more) scored between 30–60%.

‘Not recommended’ was assigned to any guidelines where most (four of more) of the domains scored below 30%.

Guidelines listed as ‘recommended’ or ‘recommended with modifications’ were selected for inclusion. Those guidelines listed as not recommended were excluded.

Step 2: Expert Committee

A committee of nine experts was purposively selected from members of international and national groups focused on optimising postnatal care provision and uptake (Appendix 2).

The Expert Committee reviewed the systematic scoping review findings to assess content validity. Discussions focused on three questions:

How likely are these signs and symptoms to occur in the first 24 hours following birth?
How essential or likely is the sign or symptom to predict maternal morbidity and morbidity within 24 hours of birth?
Can the sign or symptom be easily assessed by a mother or her birth companion without extensive training?

The Expert Committee were invited to suggest any additional signs and symptoms they deemed pertinent for inclusion.

Step 3 and 4: Delphi Survey

A two-round anonymised electronic Delphi Survey was designed on Joint Information Systems Committee (JISC) software.¹¹

E-mail invitations, including a link to the Delphi Survey, were sent to relevant contacts of the research team to participate in the study. Invitees were encouraged to share the survey in their network resulting in snowball recruitment. The survey was also advertised through social media to gain a global response. Newly identified participants were sent personal e-mail invitations to participate in the study including a link to the survey.

There are no clear guidelines on sample size calculations required for a Delphi Survey.^12,13 Previous models have suggested that a minimum of five in each area of expertise would be sufficient to be provide content validity and varied input to produce meaningful and generalisable results.^12,13 Initial stakeholder mapping identified four key stakeholder groups to be included (Clinicians, Academics/Researchers, Public Health officers and programmers, Women’s Representatives). The researchers aimed towards a minimum sample size of 50 participants to account for potential attrition in Round 2 and likelihood of respondents crossing stakeholder groups.

During the Delphi Survey, participants were asked to rate the importance and possibility for mothers and birth companions to assess each of the signs and symptoms. Participants were asked to rate between 1 and 7 on a Likert scale with 1–2 being ‘not important’, 3–5 being ‘important but not critical’ and 6–7 being ‘critically important’. Participants had the option to select “unable to comment”.

In round 1, a free-text option enabled participants to suggest additional signs and symptoms that were not already listed.

Consensus for the Delphi Survey was defined a priori based on the limits used to develop the core outcome sets.¹⁴ In this study, for an item to have achieved full consensus and be termed ‘critically important’, at least 75% of participants needed to score the item as ‘critically important’ with < 15% of participants scoring the item as ‘not important’. Items that did not achieve consensus and were scored ‘not important’ required at least 75% of participants to score it as such and < 15% to score the item as ‘critically important’. Any items not meeting either category would have achieved some consensus and be termed “somewhat important”.

A sensitivity analysis was conducted for signs and symptoms graded as “somewhat important”. Signs and symptoms with similar phrasings were arranged under a specific sign/symptom category irrespective of condition. The highest score each respondent attributed to any of the signs and symptoms within that category was recorded. Each sign and symptom was graded using the Likert scale, as above.

First round of the Delphi Survey

The first Delphi Survey was open for four weeks. Two reminder emails were sent to non-responders across the survey period.

During the first round of the Delphi Survey, no signs or symptoms could be excluded. An additional 10 signs and symptoms were suggested by the respondents and added, resulting in a new questionnaire with 144 signs and symptoms for the second round of the Delphi Survey.

Second round of the Delphi Survey

Responders to the first Delphi survey were also invited to participate in the second round. No new participants were invited at this stage and non-responders from round 1 were not invited to participate in round 2.

In Round 2, the revised questionnaire containing the 144 signs and symptoms was emailed directly to the Round 1 Delphi respondents. Within the survey, participants were provided with the results from round 1 (percentage of participants rating each sign or symptom as critically important), based on Delphi methodology. This enabled those receiving the survey to reflect on existing responses before completing round 2.¹⁵

The Delphi Survey closed 4 weeks after the start of round 2 and weekly reminder emails were sent until closure of the questionnaire.

Step 5: Consultation meeting

The Expert Committee met to discuss the results of round 1 and 2 of the Delphi Survey. Prior to the meeting, the committee were provided with the collated results from both rounds of the survey. The committee members were asked to prioritise the list of key signs and symptoms deemed most critical (> 75% or above). Duplicates, those considered difficult for the mothers and birth companions to assess, and those occurring over 24 hours after birth were removed from the list. Next the list of signs and symptoms deemed ‘somewhat critical’ were reviewed. Duplicates, and those considered difficult for the mothers and birth companions to assess, were removed from the list. Finally, the committee reviewed all results to reach a final consensus on the key signs and symptoms that could be self-assessed by mothers, with the support of their birth companions.

Ethics approval

for this study was gained through University of Liverpool Ethical Review Committee (Ref: 9743).

Step 1: Systematic scoping review

A total of 20,734 articles relevant to iPNC were identified (Appendix 3) were screened. Forty-four CPGs were identified, which met eligibility criteria, and were included in the review (Appendix 4). Of these guidelines, 13 were intended for an international audience, 30 were specifically for high income countries and six were created for low- and middle-income country (LMIC) settings. Only 11 guidelines were specifically for the postnatal period.

A total of 351 maternal signs and symptoms, across 12 condition categories pertaining to the immediate postnatal period, were identified.

Step 2: Expert Committee

The Expert Committee reviewed the initial list of 351 signs and symptoms for content validity. One duplicate was removed, and 232 signs and symptoms were excluded. One hundred and seven were deemed unlikely to occur within the first 24 hours of birth; 45 were not considered essential for predicting maternal morbidity and mortality; and 79 were considered unsuitable for assessment by a mother or her birth companion, without additional equipment. Alternative phrasing was proposed for six signs and symptoms that had previously been excluded and as such were re-added. An additional nine signs/symptoms were suggested. Discussions resulted in the creation of a list of 134 signs and symptoms, arranged in seven condition categories, to be reviewed during the first round of the Delphi Survey (Appendix 5).

Steps 3 and 4: Delphi Survey

One hundred and thirteen respondents, from 10 countries, completed round one of the Delphi Survey. Fifty-nine of these respondents, from nine countries, subsequently completed round two (52%) Most of the round two respondents (94%) were practising health care workers (Table 2). Most respondents had been working in clinical practice for at least 5 years. There were 51% of respondents from high-income-settings, 37% from lower-middle-income settings and 12% from low-income settings.

Table 2

Demographics of Delphi respondents
		Round 1 (n = 113)		Round 2 (n = 59)
		Number	%	Number	%
Role	Clinicians	101	89	55	94
	Academics/researchers	6	6	2	3
	Public Health officers and programmers	5	4	2	3
	Women’s representatives	1	1	-	-
Length of Duty	> 10 years	61	54	31	53
	5–10 years	26	23	16	27
	2–4 years	15	13	6	10
	1 year or less	11	9	6	10
Country	UK	40	36	28	48
	Nigeria	22	19	7	12
	Uganda	16	14	7	12
	Kenya	14	12	6	10
	Nepal	11	9	4	7
	Tanzania	2	2	2	3
	USA	2	2	2	3
	India	4	4	2	3
	Ghana	1	1	1	2
	Australia	1	1	-	-

Step 5: Expert Committee

When reviewing the results of each round of the Delphi Survey, the Expert Committee highlighted the value of a broad list of signs and symptoms, not limited to specific conditions occurring in the postnatal period, given that many signs and symptoms span multiple conditions. Of the 144 signs and symptoms reviewed in round 2 of the Delphi survey, 35 (24%) were considered ‘critically important’; 109 (76%) ‘somewhat important’; and none were deemed unimportant or excluded (Fig. 1).

‘Critically important’ signs and symptoms

Of the 35 most critically important signs, the Expert Committee excluded 23 of them. Thirteen were duplicates; 10 were deemed difficult for a mother and birth companion to assess without training and equipment or would occur after 24 hours following birth. Twelve were selected for inclusion in the list of key signs and symptoms. These included, “change in consciousness, seizure, severe headache, persistent visual impairment, urinary incontinence, chest pain, shortness of breath, severe pallor, fast heartbeat, rejection of baby, suicidal/infanticidal, fever”.

‘Somewhat important’ signs and symptoms

For the 109 somewhat important signs and symptoms, a sensitivity analysis was conducted. Ten signs and symptoms categories contained at least one sign or symptom that was scored as “critically important” by more than 75% of respondents. These were dizziness, amount of blood loss, foul smelling discharge, hallucinations/delusions, inability to pass urine, depression, rigors, lethargy, coloured urine and soft flabby uterus. Fifty-four signs and symptoms were listed within the ten sign and symptoms categories and excluded as duplicates. Forty-five signs and symptoms were not housed within the ten important signs and symptoms categories and excluded as deemed not important.

The Expert Committee advised renaming two of the signs and symptoms for clarity. Coloured urine was renamed “abnormally coloured urine”, and amount of blood loss was renamed “heavy blood loss”.

Three signs and symptoms; “lethargy”, “hallucinations and delusions” and “depression” were excluded as the Expert Committee considered them to be difficult for a mother and birth companion to assess.

A final list of 19 signs and symptoms that were important and possible to be assessed in the immediate postnatal period were selected as below:

Change in consciousness
Seizure
Severe Headache
Persistent visual impairment
Urinary incontinence
Chest pain
Shortness of breath
Severe pallor
Fast heartbeat
Rejection of baby
Suicidal/infanticidal
Fever
Syncope/dizziness
Heavy blood loss
Foul smelling discharge
Unable to urinate easily
Rigors
Abnormal coloured urine
Soft flabby uterus

Main Findings

This study achieved its aims of developing consensus on the key signs and symptoms, predictive of maternal morbidity and mortality in the immediate postnatal period (first 24 hours following birth), that could be self-assessed by mothers supported by their birth companions. A list of 19 key signs and symptoms, spanning seven condition categories (postpartum haemorrhage, genital tract sepsis, cardiovascular disease, preeclampsia/eclampsia, urinary dysfunction, anaemia, postpartum psychosis), was developed. The research team believe this to be the first evidence-based self-care strategy for use in the immediate postnatal period to be developed.

Strengths and Limitations

The study has several strengths. First, a mixed methods approach was designed. A three-step systematic scoping review identified an expansive list of signs and symptoms from CPGs. Quality assessment was completed using the AGREE II tool to ensure only signs and symptoms from reputable guidelines were included.¹⁶ The Delphi method enabled the involvement of a diverse range of lay and professional stakeholders from geographically distant regions. The use of snowball recruitment using the social media platforms was a useful method of recruitment. Over 90% of participants had at least two years of professional experience. Although the study was led by a UK based research team, there was representation from higher income settings and lower to middle income settings within the Expert Committee and Delphi respondents to enhance the generalisability of the results. The Delphi process also enabled participants to consider the views of others and develop their own opinions. Discussion and debate by the Expert Committee led to further refinement and agreement of the final tool.

There are several limitations to consider. First, although there was a large participation in the survey, representation from each stakeholder group was not evenly distributed with 93% of respondents being health workers in round 2 and there was only one patient representative in round 1. It is likely that some participants belonged to more than one stakeholder group, but data are not available to explore this further. Secondly, no signs and symptoms were deemed “not important” during the Delphi process and could be removed. This is unsurprising as all signs and symptoms were retrieved from international recommendations and as such will all be somewhat important at the very least. The limits for consensus were developed a priori and in line with existing Delphi studies.^14,17 It might however have been prudent to have developed a limit for the ‘somewhat important’ category too or utilised an alternate method for rating such as ranking of outcomes.

Interpretation

The four conditions with the highest number of recommendations associated were postpartum haemorrhage, pre-eclampsia/eclampsia, genital tract sepsis and anaemia. Global findings indicate that PPH, Pre-eclampsia/eclampsia and genital tract sepsis account for more than half of maternal deaths worldwide.¹⁸ Additionally, anaemia is widely regarded as a risk factor for worsening outcomes in those experiencing PPH.¹⁸ Given the high morbidity and mortality associated with these conditions, it would seem logical that more guidelines are available that focus on them. However, most guidelines are specifically for high income settings. This is problematic given that the highest maternal morbidity and mortality occurs in LMIC’s. Additionally, there were few country-specific recommendations which are critical to implementing guidelines into clinical practice. Absence of national guidelines and local protocols in maternal health in LMIC’s has been highlighted as a key barrier preventing implementation of high-quality care.¹⁹ Contextualised guidelines, to promote and support consistent delivery of high-quality care in these settings, are urgently needed.

There were no CPGs focussing solely on the immediate postnatal period. Of the 44 guidelines included in the review, only 25% (11 guidelines) were specified for the postnatal period. Most guidelines covered the antenatal, intrapartum and postnatal period. This was highlighted in a previous systematic review, with only six international guidelines focussing specifically on postnatal care.²⁰ Over the past decade, there has been a move to promote continuity of care, through integration of services. The benefits, and improved health outcomes from this approach, are well documented.^19,21 However, in addition to integration, there is a need to ensure renewed priority to poorly covered services such as iPNC where the morbidity and mortality is greatest.^21,22 Development of specific clinical guidelines on postnatal care would provide the much-needed focus on key health issues, guiding health care providers, programme officers and policy makers in providing comprehensive, high-quality care.

The quality of CPGs reviewed varied greatly with a lack of detail and transparency of the development processes by the guideline developers. These findings are consistent with other quality assessments of clinical practice guidelines in maternal care.^20,23,24 There is a need for guideline development processes to be made explicit, to ensure the content is evidence based and enable practitioners to make informed decisions about whether to adopt the guidance.

There is a paucity of literature on danger signs and symptoms specifically within the first 24 hours of birth. For example, the 2022 WHO postnatal care guidelines and the Ugandan Clinical Guidelines only mention danger signs and symptoms for ongoing counselling beyond the first 24 hours of birth. ^25,26 Within the WHO guidance for ongoing counselling, four conditions were mentioned (postpartum haemorrhage, pre-eclampsia/eclampsia, infection, and thrombo-embolism), and all except thromboembolism have been considered within the list of signs and symptoms. Thromboembolism was considered but disregarded by the Expert Committee as they were reported to be unlikely to occur in the first 24 hours after birth. From the three included categories, all signs and symptoms aligned with those described in the WHO signs and symptoms except epigastric abdominal pain. In the Delphi Survey only 66% of participants ranked this symptom category as critically important and as such it was excluded during sensitivity analysis. The three conditions with the highest number of recommendations associated were postpartum haemorrhage, pre-eclampsia/eclampsia and genital tract sepsis which makes sense, as global findings indicate that these three conditions together account for more than half of maternal deaths worldwide.¹⁸

Despite the risk of maternal mortality and morbidity, after caesarean birth, being five times higher than following vaginal birth, there were no CPGs for assessing signs and symptoms following caesarean birth.^27–29 Only one sign/symptom mentioned caesarean birth, and this was blood loss greater than 1000mls for postpartum haemorrhage. Interestingly, experts in postnatal care highlighted the need for inclusion of signs and symptoms specific to caesarean birth, both during discussions with the Expert Committee and during the Delphi Survey. Given the higher risks of morbidity and mortality associated with caesarean section, there is a need for specific guidance on the assessment of signs and symptoms following caesarean births. This should be separate to that for vaginal birth.

When preparing for the Delphi Surveys, there were often multiple ways to describe each sign and symptom based on differing country or setting. The need for careful attention of the language and phrasings used in a recommendation document is highlighted within the WHO handbook for guideline development.³⁰ Literature has reported on the pitfalls occurring particularly with patient reported tools, where poor language choices can lead to misinterpretation of signs and symptoms.³¹ It is therefore imperative that beyond securing the signs and symptoms, attention is taken to ensure the phrasing and language used for the signs and symptoms are context specific to each setting.

International expert consensus was achieved on a list of 19 key signs and symptoms spanning six condition categories that are important and deemed possible that mothers supported by their birth companions could assess in the first 24 hours postnatally. Further work is needed to ensure that this proposed list is adapted to individual regional and country settings to meet the needs of the women and birth companions in such settings in the context of self-monitoring in the immediate postnatal period.

Ethics approval and consent to participate

All members of the Expert Committee were approached for participation by email providing information of the study. No members declined participation. No renumeration was made to the Expert Committee for their time and contribution to the study.

All members who participated in the Delphi survey were provided information about the study on the survey link. Members provided consent through the survey link. No renumeration was made to the Delphi respondents for their time and contribution to the study.

Consent for publication

Not applicable

Availability of data and materials

Not applicable

Competing interests

The authors declare that they have no competing interests

Funding

Funding for this project was through the University of Liverpool Research and Development Scheme. The funders did not have a role in the conduct of the research.

Authors' contributions

TD, TL and ADW devised the project and methodology. TD and NB conducted the analysis. TD produced the first draft manuscript with input from all authors (TD, NB,AH,LB, MM,EVL, SO, TL, ADW).

Acknowledgements

The authors acknowledge the invaluable contribution from the Delphi respondents during the Delphi Consensus Building process.

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No competing interests reported.

Appendix.docx

Critical signs and symptoms for self-assessment in the immediate postnatal period: an international Systematic Scoping Review and Delphi consensus study

Status:

Version 1

Abstract

Background

Methods

Results

Conclusion

Figures

Background

Methods

Step 1: Systematic Scoping Review

Step 2: Expert Committee

Step 3 and 4: Delphi Survey

First round of the Delphi Survey

Second round of the Delphi Survey

Step 5: Consultation meeting

Results

Step 1: Systematic scoping review

Step 2: Expert Committee

Steps 3 and 4: Delphi Survey

Step 5: Expert Committee

Discussion

Main Findings

Strengths and Limitations

Interpretation

Conclusion

Declarations

References

Additional Declarations

Supplementary Files

Status:

Version 1