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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 See Hemminki 1990a.
Participants See Hemminki 1990a. 161 women were enrolled in Trial B (81 in the support group and 80 in control)
Interventions Trial B: in 1988, the intervention was support by a new group of midwifery students.
All students were involved in the trial, not just volunteers. The students were permitted to leave their participants to witness other interventions and deliveries
The control group ‘was cared for according to the normal routine of the midwife’ and by a medical student as enrolment was limited to days when medical students were on duty
Slightly less than 70% of fathers were present.
Outcomes See Hemminki 1990a.
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 No details provided.
Allocation concealment (selection bias) Unclear risk The block size was reduced from the first study. ‘To lessen the frustration resulting from opening a code for a control mother, randomisation envelopes contained a maximum of two similar codes in sequence (not told in advance)’. ‘Put into non-transparent envelopes’. The envelope was opened in the labour ward. It was not stated if the envelopes were consecutively numbered
Blinding (performance bias and detection bias)
All outcomes
High risk Medical record outcome were collected unblinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk Medical record data were collected on 100% of the sample. A questionnaire was administered at 2-3 days postpartum and completed by 93.7% of the sample
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias High risk Mothers were told the purpose of the study differentially (see methods for Trial A above)