Continuity of care and enhanced support for women experiencing antenatal distress: A pilot randomised controlled trial

doi:10.21203/rs.3.rs-3617637/v1

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Continuity of care and enhanced support for women experiencing antenatal distress: A pilot randomised controlled trial

https://doi.org/10.21203/rs.3.rs-3617637/v1

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Background

Evidence suggests that enhanced midwifery care may lead to reduction of antenatal distress among pregnant women. Nevertheless, the access/uptake and outcomes for expectant mothers from culturally and linguistically diverse (CALD) backgrounds may be limited. Therefore, this study investigated the effects of enhanced midwifery care in reducing antenatal distress among pregnant women presenting with elevated but sub-clinical symptoms of depression in an ethnically diverse, socio-economically, and geographically disadvantaged area in the South Western Sydney Local Health District (SWSLHD).

Methods

A multisite, single-blinded, randomised controlled trial was conducted with a follow-up period of 6 months. Participants included pregnant women attending the Fairfield and/or Liverpool Antenatal clinic with an Edinburgh Depression Scale (EPDS) score of 10–12 and a psychosocial assessment during the first antenatal visit. Participants were randomly allocated to either the intervention group or usual care group. The enhanced midwifery care was led by a dedicated Research Midwife (RM) that provided care coordination/navigation and social care support from pregnancy to the early postnatal period whereas the usual care group received routine antenatal care. Primary outcomes included reduction in mental ill-health symptoms assessed via EPDS and Kessler’s Psychological distress (K10) assessments whereas secondary outcomes included improvement in parenting confidence (Karitane Parenting Confidence Scale (KPCS)). Linear mixed-effects model was used to examine the effects of treatment on outcomes. Fixed-effects such as time, treatment, and time-by-group interactions were also assessed separately for each outcome variable whilst adjusting for confounders.

Results

37 mothers were recruited into the study, 18 were randomised to the intervention group and 19 to the usual care group. Findings of the mixed-effects model showed significant within group differences in EPDS scores as indicated by the significant effect of time but no significant effect of treatment. Further, there were no significant effects of time, treatment, or significant interactions between time and treatment group for K10 and KPCS.

Conclusion

Findings showed non-significant improvements in antenatal distress and parenting confidence among expectant mothers in the enhanced midwifery care model group compared to usual care. Larger and appropriately powered trials are needed to determine whether small differences in care can reach statistical and clinical significance.

Trial registration:

Australian New Zealand Clinical Trials Registry (ACTRN12623000698673).

Antenatal distress

enhanced midwifery care

continuity of care

parenting confidence

CALD

Antenatal distress, characterised by heightened emotional distress and anxiety during pregnancy, is a prevalent concern among expectant mothers and has significant implications for maternal and foetal health [1, 2]. The prevalence of antenatal distress varies widely across studies but has been reported to affect between 10 and 20% of pregnant women [3]. These rates are exacerbated among women from culturally and linguistically diverse (CALD), and socioeconomically or geographically disadvantaged, communities as they are particularly vulnerable to developing emotional distress or mental health disorders in the perinatal period [4]. Evidence shows that undetected anxiety and depression are very common and can pose risks to mother’s health and psychosocial wellbeing and interrupt the mother/infant relationship leading to psychological, developmental, and neurocognitive disorders for offspring [5]. Moreover, maternal antenatal distress is also associated with long-term developmental outcomes that extends beyond infancy, into childhood and adolescence [6]. Besides health ramifications, the Productivity Commission report in 2019 estimated the cost of perinatal depression in Australia amounting to $877 million including for health system use, productivity loss, and poor wellbeing in year one with additional lifetime costs up to $5.2 billion. Therefore, early identification and tailored intervention supports are essential in reducing the health and economic burden associated with antenatal distress.

The antenatal period offers a unique opportunity for intervention and support to prevent or to limit any further exacerbation of negative outcomes. The effectiveness, however, of current healthcare systems in addressing antenatal distress remains a matter of concern due to reasons such as limited staff numbers, inadequate training and support of midwives, fragmented services, discontinuity of care, and limited access to specialist mental health support, thus hindering timely identification and management [7, 8]. In view of this, several governmental initiatives have been implemented, one of which is the New South Wales (NSW) SAFE START model aimed at universal psychosocial assessment, depression screening, and follow-up care and support for parents during the perinatal period (period of time from pregnancy to 1 year postpartum) [9]. In this program, routine screening of pregnant women for current or potential mental health problems is mandated throughout maternity services and risk is assessed using the Edinburgh Depression Scale (EPDS) [10]. In the SAFE START psychosocial assessment, women are categorised as: Level 1 – no vulnerabilities detected; Level 2 – predominately social issues such as lack of support, unemployed partner, unstable housing; and Level 3 – complex risk factors such as mental illness, domestic violence or substance abuse. While universal psychosocial assessment during the initial antenatal assessment has been shown to be critical for identifying social care needs early with the provision of relevant supports [11], this model has subsequently been limited owing to lack of continual staff training and support, unaffordable antenatal classes, and lack of availability of suitable referral pathways, with case review and referral to services only occurring for women in the highest depression risk categories (EPDS > 13). Women with anxiety and/or low to moderate depression or low psychological resources, and likely impacted by the social determinants of health, who are identified as needing support, often fall between the service gaps [12, 13]. This is concerning as women who are distressed, but not necessarily clinically depressed, during pregnancy also require particular attention to reduce the likelihood of developing postnatal depression and anxiety [14]. This concern is exacerbated for women from CALD backgrounds, who are less likely to seek help and may under-report their mental health concerns [15].

The enhanced midwifery care model has demonstrated better birth and neonatal outcomes and satisfaction (level 1 evidence) [16] and is emerging as a promising approach to improve maternal stress and depression among pregnant and postnatal women [17, 18]. This model comprises continuity of care by midwife or group of midwives, care coordination, targeted education and care, and ongoing monitoring and support of health and wellbeing during pregnancy and the postnatal period [19]. Midwives offering continuity of care are particularly able to enhance women’s access to and usage of mental health services as they develop trusting relationships with expectant mothers, identify when they need support, provide relevant information and facilitate connection to services [20]. However, research specifically focused on the impact of continuity of care on antenatal distress among expectant mothers from priority population groups (CALD and socioeconomically disadvantaged communities) is limited. This study aimed to address this gap by investigating the effects of an enhanced midwifery care model in reducing antenatal distress among pregnant women from CALD communities in the South Western Sydney Local Health District (SWSLHD). Findings of this study will help inform healthcare policy and practice to better meet the mental health needs of pregnant women, thereby promoting healthier pregnancies and improved maternal, neonatal, and family outcomes, particularly among priority population groups.

Study design, sites, and participants

A multisite, single-blinded, pilot randomised controlled trial (RCT) with an embedded process evaluation component was employed to compare an enhanced midwifery care model versus usual care. Participants were recruited from two tertiary public hospitals (Fairfield and Liverpool Hospital) located in the SWSLHD. Inclusion criteria included pregnant woman attending the Fairfield and/or Liverpool Midwifery clinic with an EPDS score above 9 and below 13 (score of 10–12) during the antenatal visit. Further, participants who planned to give birth at a different hospital were excluded from this study.

Randomisation and allocation concealment

A randomisation procedure was followed whereby each woman was randomised to either condition. Randomisation was attended through REDCap after the participant had consented to be involved in the study. REDCap Randomization Module is a process that assigns participants by chance (rather than by choice) into specific groups and is concealed from the recruiters [21]. Participants were not stratified by risk profile. Allocation in REDCap was assigned after all the participants’ baseline information was obtained alongside signed electronic consent. The Research Midwife (RM) and participants were not blinded to the type of care after randomisation had taken place.

Recruitment and consenting process

Expectant mothers attending their first antenatal clinic appointment (booking visit) and less than 26 weeks gestation scoring 10–12 on EPDS were approached and asked whether they would like to hear more about the study. This was done via phone, email, or face to face by the RM. Further, the RM accessed booking records to proactively identify eligible women prior to their scheduled visits. During COVID lockdown, the Antenatal booking clinic schedule were screened daily from each participating hospital by the RM to find eligible women for the study. These women were then contacted via mobile or SMS requesting their participation. If interested, an email address was collected and information about the study and the REDCap link for consenting was sent. The RM reached out to women who indicated that they would like more information to discuss what participation in the study would entail. Prospective participants interested in the study were provided with the information sheet and consent form via a REDCap link. Informed consent was collected electronically through REDCap.

Intervention

Participating mothers were randomised to receive enhanced midwifery care model or usual care.

Enhanced midwifery care model group

This enhanced care model was led by a dedicated Research Midwife (RM) working in liaison with a multidisciplinary team involved in the care of the women and children including other midwives, the obstetric team, social workers, Child and Family Health Nurses (CFHNs), General Practitioners (GPs), Allied Health, and mental health staff. The RM provided care coordination/navigation and support from pregnancy to the early postnatal period as well as social care support. Some of the women requested to have the RM as a support person at their antenatal visit, others would contact the RM via text message or email or a phone call to ask questions, for reassurance or extra assistance with referrals, especially during COVID lockdown.

The number of contacts a woman had with the RM ranged from 1 to 18 times throughout the period of the study. Services were drawn from a pool of non-pharmacological interventions shown to have some efficacy in preventing postpartum anxiety/depression or increasing service provision and engagement. This included access to individualised care planning, home visiting, telephone support, the offer of debriefing after birth, social support and flexible care provision including outreach [22–27]. Additionally, the RM providing continuity of care also received light-touch training in mental health first aid strategies such as receptive listening, maintaining a supportive attitude, and sensitively querying about maternal mood.

Usual care group

Women in the “usual care” group received usual care etc that is care provided by a range of midwives in pregnancy, birth and the postnatal period as well as obstetric and other medical specialist care; social work and or mental health

During the study, women in either group who received a high score for any of the assessments done at each timepoint were contacted and referred accordingly for duty of care and adequately supported. For example, one of the mothers in the usual care group screened as experiencing significant mental health concerns at Time 1, she was then contacted, and the team discovered she was highly stressed completing her workload prior to starting maternity leave. The team liaised with the CFHN who had linked the mother with the Sustained NSW Families program of social support. The intervention was followed-up by phone contacts in which the mother reported feeling much better.

Data collection and outcomes

This study involved the delivery of questionnaires at four timepoints (T0 - recruitment: before 26 weeks gestation, T1: 36 weeks gestation, T2: 8 weeks post-partum, and T3: 6-month follow-up) to evaluate women’s experience of care across the two groups.

Edinburgh Postnatal Depression Scale (EPDS) is a short self-reported assessment employed to identify mothers at risk of depression [10]. The assessment comprises of 10 short statements with scores ranging from 0 to 30 with a score of 13 and above being indicative of likelihood of meeting criteria for a psychiatric diagnosis of depression. This was collected at all four timepoints (T0, T1, T2, and T3). The EPDS has also been used to assess level of anxiety [28] with three very specific anxiety-related questions [29].
Kessler’s Psychological Distress Scale (K10) is a standardised self-reported measure of anxiety and depressive symptoms over the past four weeks, with scores over 20 indicative of a mild mental disorder. This was collected at T1, T2, and T3.
Karitane Parenting Confidence Scale was employed to determine parenting self-efficacy in parents of infants during the first year. The assessment comprises 15 items with scores ranging from 0 to 45 where a score of 39 or less indicates lower confidence levels. This assessment was collected at T2 and T3.
Sociodemographic information collected included mother’s age (in years), country of birth (Australia/Other), language spoken at home (English/Other), indigenous status (Yes/No), smoking status (Yes/No), and number of weeks pregnant at the time of enrolment.

Primary outcomes included reductions in mental health symptoms assessed via EPDS and K10 assessments whereas secondary outcomes included improvements in parenting confidence.

Sample size calculation

Using an α = 0.05 and a β = 0.08, with two groups measured over three time-points (assuming a correlation between measures of 0.5 and a non-sphericity correction will yield enough sensitivity to detect a small-to-medium effect size of 0.18 (a low effect size is 0.1 and a medium effect size is 0.3) when investigating within-between interactions in a repeated-measures ANOVA. This sensitivity was judged to be adequate for a pilot study, which is not intended to maximise its specificity but rather as a proof of concept demonstrating one group will show different changes over time than another.

Data analysis

Data management was facilitated through the REDCap online platform. Descriptive analyses such as independent samples t-test and chi-square tests or Fisher’s exact tests were used to determine any significant differences in demographic and clinical characteristics across the treatment groups. Primary analysis included an intention-to-treat (ITT) linear mixed effects model with Bonferroni correction for multiple corrections, to examine the effects of treatment on primary and secondary outcomes. Linear mixed-effect models can effectively account for within-subject correlations and handle unbalanced data, making them well-suited for analysing RCT data with missing values [30]. Fixed effects such as time, treatment group, and time by group interaction were also assessed separately for each outcome variable whilst adjusting for sociodemographic covariates. Significant effects were followed up with pairwise contrasts comparing group differences in pre-to-post and pre-to-follow-up total scores. P-values less than 0.05 were considered statistically significant. All analyses were undertaken in Statistical Package for the Social Sciences (SPSS) version 28 (IBM SPSS, IBM Corp., Armonk, NY, USA) and R studio version 4.1.2.

Participant characteristics

Baseline demographic and clinical characteristics of the participants by treatment groups are shown in Table 1. A total of 37 mothers were recruited into the study of which 18 women were randomised to the intervention group and 19 women to the usual care group. A recruitment flowchart is presented as Fig. 1. The sample was ethnically diverse with 65% identifying as from ‘non-Caucasian’ background. The average age of the participants was 30 years, and they were on average, 19 weeks pregnant at the time of enrolment. In terms of their CALD backgrounds, almost 50% were born overseas and more than 70% spoke a language other than English at home. Nevertheless, there were no significant differences in baseline characteristics between the two groups.

Table 1

Baseline demographic and clinical characteristics by treatment groups
Variables	Intervention group (N = 18) n (%)	Control group (N = 19) n (%)	p-value
Mother’s age in years, mean (SD)	29.1 (7.1)	30.6 (6.0)	0.501
Number of weeks pregnant, mean (SD)	18.4 (4.5)	19.3 (3.5)	0.514
Country of birth			0.618
Australia	10 (55.6)	9 (47.4)
Other	8 (44.4)	10 (52.6)
Ethnicity			0.632
Caucasian	6 (33.3)	5 (26.3)
Non-Caucasian	11 (61.1)	13 (68.4)
Missing/Undisclosed	1 (5.6)	1 (5.3)
Language spoken at home			0.800
English	13 (72.2)	16 (84.2)
Other	5 (27.8)	3 (15.8)
Indigenous status			0.604^a
No	17 (94.4)	16 (84.2)
Yes	1 (5.6)	3 (15.8)
Smoking status			1.000^a
No	17 (94.4)	18 (94.7)
Yes	1 (5.6)	1 (5.3)
^aFisher’s exact test for variables with more than 20% of cells with expected counts below 5.

Clinical assessments across timepoints

Comparison of mean scores of clinical assessments by intervention and control groups across the timepoints are shown in Table 2. Findings of the independent samples t-tests showed reduction in both EPDS and K10 scores as well as improvement in KPCS scores among the enhanced midwifery care model group compared to usual care group across different timepoints, but the findings were not statistically significant.

Table 2

Comparison of mean scores of clinical assessments by intervention and control groups across the timepoints
Assessments	Treatment Mean (SD)	Control Mean (SD)	Mean difference (95% CI)	t statistic	p-value
EPDS
EPDS at T0	11.11 (0.83)	10.84 (0.77)	0.27 (-0.26, 0.80)	1.025	0.313
EPDS at T1	8.50 (5.02)	9.63 (6.87)	-1.13 (-5.96, 3.71)	-0.479	0.636
EPDS at T2	7.18 (4.60)	8.24 (5.54)	-1.05 (-5.19, 3.08)	-0.524	0.605
EPDS at T3	8.25 (4.98)	9.94 (7.45)	-1.69 (-6.81, 3.43)	-0.678	0.504
K10
K10 at T1	19.50 (8.31)	19.63 (10.42)	-0.13 (-7.67, 7.40)	-0.034	0.973
K10 at T2	17.36 (6.89)	18.65 (7.69)	-1.28 (-7.16, 4.60)	-0.449	0.657
K10 at T3	18.42 (7.34)	20.69 (8.55)	-2.27 (-8.60, 4.06)	-0.737	0.467
KPCS
KPCS at T2	38.91 (2.81)	37.82 (5.18)	1.09 (-2.43, 4.60)	0.635	0.531
KPCS at T2	39.75 (2.14)	39.33 (4.64)	0.42 (-2.39, 3.22)	0.287	0.777
T0: Recruitment (before 26 weeks gestation); T1: 36 weeks gestation; T2: 8 weeks post-partum; T3: 6-month follow-up.

Findings of the linear mixed effects models

The results of the ITT linear mixed-effects models for EPDS, K10, and KPCS scores are presented in Table 3 and Fig. 2. The mixed-effects model showed a significant effect of time but no significant effect of treatment and no interaction between treatment and time for EPDS scores. Further, there were no significant effects of time, treatment or a significant interaction between time and treatment group for K10 and KPCS (Table 3 and Fig. 2).

Table 3

Linear mixed effects models
Outcomes		β	SE	p-value
EPDS scale	Intercept	16.42	4.34	0.001
	Treatment (Ref = Control)	-0.02	1.63	0.992
	Time (Ref = T0)
	T1	-1.50	1.39	0.283
	T2	-2.77	1.36	0.045
	T3	-1.14	1.39	0.414
	Time (Ref = T0) x Treatment (Ref = Control)
	Time (T1) x Treatment (Intervention)	-1.15	2.08	0.581
	Time (T2) x Treatment (Intervention)	-1.34	2.10	0.524
	Time (T3) x Treatment (Intervention)	-1.80	2.08	0.389
K10 scale	Intercept	27.04	9.19	0.007
	Treatment (Ref = Control)	-0.58	3.20	0.856
	Time (Ref = T1)
	T2	-1.20	1.93	0.535
	T3	1.06	1.97	0.593
	Time (Ref = T1) x Treatment (Ref = Control)
	Time (T2) x Treatment (Intervention)	-1.05	3.02	0.729
	Time (T3) x Treatment (Intervention)	-1.99	2.99	0.509
KPCS scale	Intercept	34.30	4.65	< 0.001
	Treatment (Ref = Control)	0.87	1.58	0.584
	Time (Ref = T2)
	T3	1.44	1.03	0.176
	Time (Ref = T2) x Treatment (Ref = Control)
	Time (T3) x Treatment (Intervention)	-0.31	1.60	0.847
Adjusted for covariates: mother’s age, number of weeks pregnant at recruitment, and CALD status (language spoken at home).

Pairwise comparisons showed significant within-group difference in EPDS over time between baseline (T0) and 8 weeks post-partum (T2) (Table 4).

Table 4

Pairwise comparisons of timepoints by EPDS scores.
Contrast	Estimate	SE	p-value
T0 – T1	2.08	1.04	0.199
T0 – T2	3.44	1.05	0.008
T0 – T3	2.04	1.04	0.212
T1 – T2	1.36	1.11	0.613
T1 – T3	-0.03	1.10	1.000
T2 – T3	-1.40	1.11	0.594

This study assessed whether an enhanced model of midwifery care is effective and acceptable for reducing mental health symptoms in a cohort of pregnant women at low to moderate psychosocial risk in a hard-to-reach group of women from ethnically diverse, socio-economically disadvantaged area of SWSLHD. Findings of this pilot RCT showed non-significant improvements in antenatal distress and parental confidence among expectant mothers in the enhanced midwifery care model group compared with the usual care group. This was a pilot study, and it may not have been sufficiently powered to detect significant improvements in the primary outcome. Hence, larger, appropriately powered trials are needed to determine whether small differences in care can reach statistical and clinical significance.

Despite no statistically significant improvements associated with the intervention, it was notable that over time both groups showed improvements in their mental health. There are several mechanisms which may have influenced the findings of this pilot study. First, it is important to consider that the study was mainly carried out during COVID-19 associated lockdowns, and therefore the health system was struggling to support women during pregnancy and post-partum stages. The increased uncertainty experienced during this period may have increased the variability in the sample – with some families finding themselves better able to cope with socio-political pressures – which in turn may have made differences between groups harder to disentangle. Similarly, it is possible that nurses at the participating hospitals were experienced in screening for comorbid mental health concerns, as this has been an area of focus in prior studies in the same setting [31].

It is also possible that women who chose to take part in the study were more likely than average clients to engage with health services and had an increased capacity to seek out supports regardless of the intervention received. This possibility arises given the large proportion of English-speaking and Australian-born families who took part in the research. While there is limited data in relation to families that did not take part in the study, the final sample appeared to be less diverse than the average population of the area. Indeed, priority population groups are generally less likely to access health services and participate in research [15]. If women with a higher capacity for engaging with services had made up an important portion of the sample, it is more likely that the light-touch intervention provided to controls (i.e., sharing information/resources) was effective in improving their mental health, rescuing from the languishing that may have been experienced had no intervention been provided. Similarly, it is possible the acceptability of the intervention, or of participation in a research study, was seen as less appetitive to non-Australian-born English-speaking families.

It is also worth considering that the 6-month follow-up period, while a strength of the study design, may not have been enough to fully capture the mental health journeys of participants. Note that differences between the intervention group and control – while remaining non-significant – appear to show increased divergence at 6-month relative to earlier timepoints. It is possible that a longer follow-up period may elucidate larger discrepancies between control and intervention groups.

A larger magnitude of differences between groups may have been present had mental health concerns been more severe at the start of the study. Considering the study focused on women with sub-clinical levels of post-natal depression, it may have been overly ambitious for the group to experience gains that moved the group average below the average population EPDS score. Indeed, both groups’ mean EPDS score changed from the “watch-and-wait” range to normative EPDS levels [32]. A larger change may have been expected if EPDS scores had been higher to begin with. This challenge is an important consideration for studies investigating sub-clinical interventions, as they may necessitate larger sample sizes to achieve similar effect sizes as those achieved by smaller groups of participants with more severe presentations.

This study faced significant challenges in its completion, including COVID-related disruptions that were associated with participant recruitment. Unfortunately, despite a short-term extension of the study, funding restrictions prevented the ongoing recruitment of participants, which may have resulted in a larger sample size. The relatively small sample size of the study limits the kinds of inferences that may be drawn from the data. The study has other additional limitations as there was no measure of fidelity or implementation to either intervention. Hence it is difficult to establish whether women accessed supports in the control group, or whether women found the midwife’s support helpful. Likewise, there was no assessment of infant outcomes.

Despite these limitations the study also has a number of strengths, including the random allocation of participants, a relatively lengthy follow-up period (of 6 months), and the successful completion of automated questionnaires by participants across timepoints. This study targeted a population that is usually very difficult to reach, demonstrating priority populations can be engaged in research studies (although noting they may require longer recruitment periods and targeted strategies to achieve a higher recruitment rate). Finally, the measures used in the study were standardised, evidence-based measures recommended by clinical practice guidelines.

In an ethnically diverse cohort of women who received enhanced midwifery care model showed non-statistically significant reductions in both anxiety/depression and mental distress as indicated by EPDS and K10 scores respectively in addition to improvement in parenting confidence level. It is possible that the small sample size may have prevented the results reaching significance. It is also worth considering that, given the cut-off score of EPDS at 13 which is clinically meaningful, women recruited to this study with scores below that cut-off score would have improved over time independently, regardless of the intervention received. Again, it may be that those that experience higher level of acuity disengage and may not participate in research studies. Further, the level of English required for study participation may also have meant that these women had the capacity to access services regardless of the support provided via the study intervention. Future studies are needed using specific interventions that target women who do not have the capacity to seek out help such as non-English speaking women. Further, larger sample sizes are needed when targeting mid-range clinical acuity, with active support from several midwives to provide the best care possible.

CALD: culturally and linguistically diverse; CFHNs: Child and Family Health Nurses; EPDS: Edinburgh Depression Scale; GPs: General Practitioners; ITT: Intention to treat; K10: Kessler’s Psychological distress; KPCS: Karitane Parenting Confidence Scale; NSW: New South Wales; RCT: randomised controlled trial; RM: Research Midwife SPSS: Statistical Package for the Social Sciences; SWSLHD: South Western Sydney Local Health District.

Ethics approval and informed consent to participate

The trial protocol was approved by the SWSLHD Human Research Ethics Committee 2020/ETH02780 and is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000698673). Informed consent was obtained from all the participants.

Consent for publication

Not applicable

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

The funding for the research study was provided by a private funder who wishes to remain anonymous. The donor wishes to remain anonymous, however, s/he is a retired researcher who believes that work in this area is important but is not currently being pursued and hence made this funding available through UNSW Philanthropy. The research nurse is being employed using this funding. The donor does have detailed knowledge of the research project, but s/he stands to gain no financial or material benefit from pursuing the research project.

Authors' contributions

AMD, VS, BB, and VE conceptualized the study and developed the study design. WP was the dedicated RM and led the data collection and follow-up. JRJ conducted the data analysis, visualization, interpretation of the findings, preparation of the manuscript. All authors have read and approved the content of the manuscript.

Acknowledgements

We gratefully acknowledge the women who participated in the study. We acknowledge the dedicated research midwives and research assistants and the support of the study by the antenatal clinics and hospital management.

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No competing interests reported.

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Reviews received at journal
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Continuity of care and enhanced support for women experiencing antenatal distress: A pilot randomised controlled trial

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Abstract

Background

Methods

Results

Conclusion

Trial registration:

Figures

Background

Methods

Study design, sites, and participants

Randomisation and allocation concealment

Recruitment and consenting process

Intervention

Data collection and outcomes

Sample size calculation

Data analysis

Results

Participant characteristics

Clinical assessments across timepoints

Findings of the linear mixed effects models

Discussion

Conclusion

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1