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. Author manuscript; available in PMC: 2014 Sep 26.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Oct 17;10:CD003766. doi: 10.1002/14651858.CD003766.pub4
Methods RCT.
Participants 34 women (primigravidas and multigravidas) at 26-37 weeks’ gestation in 2 Texas hospitals (20 to supported group and 14 to usual care). They were in early, uncomplicated preterm labour
Interventions Intervention: support provided by a Lamaze childbirth preparation instructor. Support included continuous presence, acting as a liaison with hospital staff, providing information, and teaching relaxation and breathing measures
Usual care: intermittent nursing care. Family members allowed to be present
Outcomes Fetal distress, caesarean birth, artificial oxytocin, labour length, Apgar scores, neonatal intensive care
Notes Not stated if epidural analgesia was available or if EFM was used routinely
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk ‘Randomly assigned.’ No further details provided.
Allocation concealment (selection bias) Unclear risk Admitting nurse telephoned research assistant to obtain treatment allocation. No details about whether the research assistant had foreknowledge of the treatment allocation scheme
Blinding (performance bias and detection bias)
All outcomes
Low risk Medical record information collected by ‘research assistants who did not know the group membership of the women’
Incomplete outcome data (attrition bias)
All outcomes
High risk Withdrawals occurred before analysis (6 (30%) in support group and 3 (21%) in control). This resulted in a follow-up rate of 73.5%. The withdrawals were done differentially in the support group, i.e. some women were withdrawn because of an event that occurred before the support person arrived. Women in the control group with the same event were not withdrawn. We were able to re-create the original study groups for 1 outcome only, caesarean birth, and therefore it is included in the analysis table
Selective reporting (reporting bias) Unclear risk No outcomes were stated a priori.
Other bias Low risk No other sources of bias noted.