Effects of redesigned community postnatal care on womens' health 4 months after birth: a cluster randomised controlled trial
Abstract
Background Much postpartum physical and psychological morbidity is not addressed by present care, which tends to focus on routine examinations. We undertook a cluster randomised controlled trial to assess community postnatal care that has been redesigned to identify and manage individual needs. Methods We randomly allocated 36 general practice clusters from the West Midlands health region of the UK to intervention (n=17) or control (19) care. Midwives from the practices recruited women and provided care. 1087 (53%) of 2064 women were in practices randomly assigned to the intervention group, with 977 (47%) women in practices assigned to the control group. Care was led by midwives, with no routine contact with general practitioners, and was extended to 3 months. Midwives used symptom checklists and the Edinburgh postnatal depression scale (EPDS) to identify health needs and guidelines for the management of these needs. Primary outcomes at 4 months were obtained by postal questionnaire and included the women's short form 36 physical (PCS) and mental (MCS) component summary scores and the EPDS. Secondary outcomes were women's views about care. Multilevel analysis accounted for possible cluster effects. Findings 801 (77%) of 1087 women in the intervention group and 702 (76%) of 977 controls responded at 4 months. Women's mental health measures were significantly better in the intervention group (MCS, 3.03 [95% CI 1.53-4.52]; EPDS -1.92 [-2.55 to -1.29]; EPDS 13+ odds ratio 0.57 [0…
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For MacArthur 2002, random sequence generation was at low risk of bias.
“A member of the Birmingham Clinical Trials Unit who was independent of the trial team, with a customised computer program, Minimisation method.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, the analysis was not ITT.
“Not ITT analysis”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, questionnaires were returned to the study office in prepaid envelopes.
“Questionnaires were returned to the study office in prepaid envelopes.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, 1 cluster was excluded following randomisation in the home visit group.
“1 cluster was excluded following randomisation in the home visit group”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, 743 of 1830 were not recruited in the home visit group.
“743 not recruited of 1830”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, allocation concealment was at low risk of bias.
“A member of the Birmingham Clinical Trials Unit who was independent of the trial team, with a customised computer program, Minimisation method.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, masking of health professionals or participants was not possible.
“Not feasible, masking of health professionals or participants was not possible.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, incomplete outcome data was at high risk of bias.
“Not ITT analysis, 1 cluster was excluded following randomisation in the home visit group, 743 not recruited of 1830, 286 of 1087 not returned at 4 month in the home visit group, 773 not recruited of 1750, 255 of 977 not returned at 4 month in the control group.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, random sequence generation used a member of the Birmingham Clinical Trials Unit who was independent of the trial team, with a customised computer program, Minimisation method.
“A member of the Birmingham Clinical Trials Unit who was independent of the trial team, with a customised computer program, Minimisation method.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, blinding of participants and personnel was at high risk of bias.
“Not feasible, masking of health professionals or participants was not possible.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, 286 of 1087 did not return at 4 month in the home visit group.
“286 of 1087 not returned at 4 month in the home visit group”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, 773 of 1750 were not recruited in the control group.
“773 not recruited of 1750”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, other bias was at low risk.
“Groups appeared comparable at baseline. Analysis took account of the cluster design effect.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, 255 of 977 did not return at 4 month in the control group.
“255 of 977 not returned at 4 month in the control group”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, 2 primary outcomes were pre-defined in the methods.
“2 primary outcomes were pre-defined in the methods.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, groups appeared comparable at baseline.
“Groups appeared comparable at baseline.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, analysis took account of the cluster design effect.
“Analysis took account of the cluster design effect.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, written informed consent was obtained.
“Written informed consent was obtained.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
For MacArthur 2002, selective reporting was at low risk of bias.
“2 primary outcomes were pre-defined in the methods.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
In a previous version of this review, data on postnatal depression scores for the MacArthur 2002 trial was entered the wrong way around and appeared to favour the control group; this has now been corrected.
“The feedback is correct - in a previous version of this review data on postnatal depression scores for the MacArthur 2002 trial was entered the wrong way around and appeared to favour the control group. The review team apologises for this serious data entry mistake and the data have now been corrected.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
Results from the MacArthur 2002 trial show a reduction in depression scores in the group receiving an extended programme of home visits by health visitors.
“so that it is now clear that results from this trial show a reduction in depression scores in the group receiving an extended programme of home visits by health visitors.”
From Schedules for home visits in the early postpartum period (2021) · cites this paper as MacArthur 2002
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References 34 · Cited by 285
- Authors
- MacArthur, C., Winter, H., Bick, D., Knowles, H., Lilford, R., Henderson, C., Lancashire, R., Braunholtz, D., & Gee, H.
- Affiliations
- University of Birmingham (GB)
- Bournemouth University (GB)
- Birmingham Women's Hospital (GB)
- Corresponding author
- MacArthur, C
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2002-02
- Volume
- 359
- Issue
- 9304
- Pages
- 378-385
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2096330702
- Cited by
- 285
- References
- 34
- Citations by year
- 2026: 5 · 2025: 3 · 2024: 9 · 2023: 6 · 2022: 9 · 2021: 14 · 2020: 7 · 2019: 7 · 2018: 8 · 2017: 7 · 2016: 17 · 2015: 14 · 2014: 11 · 2013: 13 · 2012: 14
- FWCI
- 17.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- UWL Repository (University of West London) (submittedVersion)
- Funders
- Health Services Research and Development
- Health Services Research Programme
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Maternal Mental Health During Pregnancy and Postpartum
- Health Sciences › Medicine › Obstetrics and Gynecology › Maternal and Perinatal Health Interventions
- Health Sciences › Health Professions › General Health Professions › Maternal and Neonatal Healthcare
- Keywords
- midwife-led care, postpartum depression, postpartum mental health, postpartum physical health, Edinburgh Postnatal Depression Scale, symptom checklist, tailored care, general practice
- MeSH terms
- Adult, Educational Status, Female, United Kingdom, Humans, Mental Health, Midwifery, Postnatal Care, Social Support, Cluster Analysis, Case-Control Studies, Patient Satisfaction, Depression, Postpartum
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