Bystrova 2008.
Methods | This is a randomised controlled trial with 4 x 2 factorial design. The factorial design takes into account 2 factors, i.e. infant location in relation to the mother and the type of infant apparel. Randomisation took place immediately after birth. Data were recorded in the delivery ward 25‐120 minutes postpartum and later in the maternity ward. St Petersburg, Russia. |
|
Participants | 176 (separate care: 44, rooming‐in:132) healthy mother‐infant dyads after normal spontaneous vaginal delivery. 23 participants excluded (separate care: 6, rooming‐in: 17) leaving total of 153 (separate care: 38, rooming‐in: 115) mother‐infant pairs for study all of whom were included in the short‐term outcomes up to discharge from hospital (on day 4 postpartum). Data for 6 months breastfeeding outcome were available for 137 mothers (135 rooming‐in, 32 separate care mothers) | |
Interventions | Group 1 infants (n = 37) were placed skin‐to‐skin on their mother's chest 25‐120 minutes after birth, while still in the labour ward and later were dressed in clothes and taken to the maternity ward for rooming‐in with their mother. Group 2 infants (n = 40) were dressed and placed in their mother's arm 25‐120 minutes after birth and then taken to the maternity ward for rooming‐in with their mothers. Group 3 infants (n = 38) were dressed and kept in the cot at the labour ward nursery 25‐120 minutes after birth and stayed in the nursery while their mother was in the maternity ward until discharged from the hospital. Group 4 infants (n = 38 ) were dressed and kept in the cot at labour ward nursery 25‐120 minutes after birth and later were taken for rooming‐in with their mothers. We analysed group 3 as the control group (separate care) and group 1, 2 and 4 as the experimental group (rooming‐in). In the rooming‐in group, the mothers were encouraged to breastfeed their infants on demand while in the separate care group, the infants were taken to their mothers' room in the maternity ward at a fixed schedule of 7 times a day for breastfeeding. |
|
Outcomes | Primary breastfeeding outcomes: breastfeeding parameters on day 4 postpartum, i.e. frequency of breastfeeding per day, duration of each feed (minutes), volume of milk ingested (mL), infant weight changes (g) and rate of exclusive breastfeeding at discharge. Secondary outcomes: median duration of 'nearly exclusive' breastfeeding, and mother‐infant interaction 1 year later using The Parent‐Child Early Relational Assessment (PCERA) Method. 'Nearly exclusive' breastfeeding is analysed as any breastfeeding in this review. The paper included in this update used a validated tool with 14 observations to assess mother‐infant interaction at day 4. Some of the elements on this tool might be considered as indirect measures of maternal confidence. |
|
Notes | This thesis was reported in a total of 5 study reports (only 2 study reports contributed data to this review). Due to skewing of the data the duration of breastfeeding was analysed as a median and interquartile range. The mean and SD was supplied by the author who warned a skewed distribution of data. The author also supplied 'nearly exclusive breastfeeding' outcomes at 6 months. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A table of allocation sequence was drawn up in advance of the trial. |
Allocation concealment (selection bias) | Low risk | The mother‐infant pairs were randomly assigned according to allocation sequence using sealed opaque sequentially numbered envelopes for primiparas and multiparas. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | It was reported that both "the researchers and the recruited women were blinded to the task". The method of blinding used for women and researchers was not stated. Comment: It would be extremely difficult to blind this intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The method of blinding of outcome assessors was not stated. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 23/176 (13%) of the mother‐infant pairs excluded from the trial post randomisation, (6/38 (15%) from the separate care group and 18/138 (13%) from the rooming‐in group. The number of exclusions and reasons for exclusion were similar across the 4 groups. However a higher proportion of exclusions in the separate care group, 5/44 (11%) compared with 6/115 (4%) in the rooming‐in groups were due to refusal of treatment allocation. At 1‐ 3‐ 4‐ and 6‐months follow‐up there were 32 and 105 in the 2 respective groups (19.9%). Those included in the 6‐month outcomes were analysed by an intention‐to‐treat principle. |
Selective reporting (reporting bias) | Unclear risk | The methods section of 1 paper stated that breastfeeding duration was studied at intervals up to 12 months, however results were not reported in any of the study publications. |
Other bias | High risk | Women in the rooming‐in group had 1 of 3 different treatments in the labour ward i.e. skin‐to‐skin contact, holding dressed baby in her arms immediately after delivery and removal of the baby form the mother during stay in the labour ward. These treatments could have independently influenced the outcome so that any effect seen in the rooming‐in group might not be attributable to the rooming‐in intervention. |
SD: standard deviation