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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, stratified by type of prenatal classes (Lamaze vs general)
Participants 145 nulliparous women (72 to support group and 73 to control) in the last trimester of a healthy pregnancy, booked for delivery at a Toronto, Canada, hospital
Interventions Support provided by a monitrice (community ‘lay’ midwife or midwifery apprentice) compared with usual hospital care, defined as the intermittent presence of a nurse. Support described as including physical comfort measures, continuous presence, information, emotional support, and advocacy. The monitrice met with the woman twice in the latter weeks of pregnancy, to discuss her birth plans
Comparable prenatal attention was provided to the controls.
All but 1 woman also had husbands or partners present during labour. Support began in early labour at home or in hospital and continued through delivery
Outcomes Intrapartum interventions, perceived control, method of delivery
Notes Epidural analgesia was available and EFM was used routinely.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer-generated table of random numbers.
Allocation concealment (selection bias) Low risk Randomisation done over the phone by a third party who had no knowledge of the participant, but used the open table of random numbers
Blinding (performance bias and detection bias)
All outcomes
Low risk All participants blinded to the intervention. Control participants received prenatal and postpartum support (after the end of data collection); experimental participants received prenatal and intrapartum support Initial collection of medical record data was not blinded. ‘Duplicate abstraction was done by a second research assistant blind to the subject’s study group assignment, on a random sample of 20 records. Interrater agreement of over 95% was obtained for all categories of intervention and physical outcomes.’ In-home interview at 2-4 weeks postpartum was blinded
Incomplete outcome data (attrition bias)
All outcomes
Low risk Method of delivery outcome available on 88.3% of sample. Other outcomes collected on only 71% of the sample and thus not used
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias Low risk No other sources of bias noted.