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. Author manuscript; available in PMC: 2014 Apr 8.
Published in final edited form as: Cochrane Database Syst Rev. 2012 May 16;5:CD003519. doi: 10.1002/14651858.CD003519.pub3
Methods Randomized controlled trial (table of random numbers).
Participants 40 healthy full term infants born by repeat cesarean section (spinal anesthesia)
Interventions 1) Control group = visual contact < 5 min, holding the swaddled infant for 10-20 min in the nursery during the first 12 hours postbirth, then rooming-in. 2) Early contact group = visual contact for 5 to 15 min, SSC for the first hour in the recovery room, then rooming-in
Outcomes 1) Neonatal Perception Inventory. 2) Postnatal research inventory. 3) Observation of maternal behavior.
All variables measured on postpartum day 1 or 2 and 28-32 days postbirth
Notes Study was done with middle-income, multipara in the USA.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated that a table of random numbers was used to ensure “no systematic bias” but then went on to say that “if the woman did not meet the characteristics of the population, she was replaced by the next woman who qualified, until there were 20 mothers in each group”
It was not clear at what point randomization occurred or how many women were randomized and excluded postrandomization and then replaced
Allocation concealment (selection bias) High risk Women were “randomly assigned”, “if the woman did not meet the characteristics of the population, she was replaced by the next woman who qualified, until there were 20 mothers in each group”
It was not clear at what point randomization occurred or how many women were randomized and excluded postrandomization and then replaced
Blinding (performance bias and detection bias)
All outcomes
Unclear risk Women would be aware of which group they were in and would be aware of observations. Clinical staff would be aware of group assignment. It was stated that the nurses carrying out observations were unaware of group assignment
Incomplete outcome data (attrition bias) All outcomes Unclear risk It was not clear how many women were randomized and then later excluded and replaced. 40 women received the intervention and all seemed to be accounted for in the analysis. It was not clear if there was any missing data.
Selective reporting (reporting bias) Unclear risk All outcomes specified in the introduction were reported on, it is not clear if other outcomes were measured, we did not have access to the study protocol.
Other bias Unclear risk Groups appeared similar at baseline.
It was not clear what the mean scores reported represented, e.g. a mean mother and infant behavior score (from observation) - whether a higher score was more positive or what was being recorded. The measure is referenced but without knowing how scoring works it is not easy to interpret the results