Milani 2017.
Study characteristics | ||
Methods | Study design: randomised controlled trial carried out in 4 affiliated hospitals (Taleghani, Shohada, Mahdie, and Imam Hossein) of Shahid Beheshti University in Iran. | |
Participants | 276 women who had delivered in these hospitals. (282 women randomised.) Eligible criteria: (1) Not having a chronic disease. (2) A single, normal weight neonate without congenital disorders. (3) EPDS score of < 10 (having depression), not having a history of depression, and not taking antidepressants. If EPDS scores were of < 10 or had suicidal thoughts, they were excluded the study and referred to a psychiatrist. (4) Iranian nationality. Exclusion criteria: (1) Unwillingness to continue the study. (2) Migration from the area of study. |
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Interventions | (1) Intervention group (n = 92) (94 women randomised) (Intiaion: > 48 hours, Duration: < 3 week, Intensity: ≥ 1/week) The intervention was the postpartum health care providing at home on the 3–5th and 13–15th day after delivery according to the designed guideline. Healthcare providers were educated midwives. The average visit time was 30–45 minutes which would change with mothers' request. The intervention included greeting and recording checklists which were filled by midwives after interviewing and examining the mother and infant on each visit. (2) Control group (n = 184) (188 women randomised) (No home visit: Intiation: NA, Duration: NA, Intensity: NA) Usual hospital‐based care, if requested. (It was only stated "lack of home visit".) |
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Outcomes | EPDS, cut‐off of score was set as mild (< 10), moderate (10‐13) and severe (> 13). | |
Notes | The study was carried out in a developing country. The trial was registered as IRCT 2013060313565N1. Dates of study: between July 2013 and October 2013 Funding sources: none Declarations of interest: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It was stated "randomly" but it was not clear how the sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | It was not clear how to do the allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not clearly described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | It was not clearly stated, but carried out ITT analysis. 2 women were with loss to follow‐up in both groups and 2 women was with missing data for outcome in control group. |
Selective reporting (reporting bias) | Unclear risk | Assessment from published study report. Primary outcome was not clearly stated, but an outcome (EPDS) was only reported and the sample size was calculated in the report. |
Other bias | Unclear risk | Proportion of Level of education and delivery type in baseline were slightly unbalanced. |