Kashanian 2010.
| Methods | RCT | |
| Participants | 100 nulliparous women at term (50 to support and 50 to routine care) in active labour at a university hospital in Tehran, Iran from March to September 2003 | |
| Interventions | "Women allocated to the intervention group were shown to an isolated room and were supported by an experienced midwife. The women were free to choose their position, and able to eat and walk about freely. During labour, the midwife explained the process of labour and the importance of body relaxation. Midwife‐led support included close physical proximity, touch, and eye contact with the labouring women, and teaching, reassurance, and encouragement. The midwife remained with the woman throughout labour and delivery, and applied warm or cold packs to the woman's back, abdomen, or other parts of the body, as well as performing massage according to each woman's request." "Women allocated to the routine care group were admitted to the labour ward (where 5‐7 women labour in the same room), did not receive continuous support, and followed the routine orders of the ward. They did not have a private room, did not receive one‐to‐one care,were not permitted food, and did not receive education and explanation about the labour process. The only persons allowed in the delivery room were nurses, midwives, and doctors." |
|
| Outcomes | Duration of labour, caesarean delivery, oxytocin use, Apgar score at 5 minutes | |
| Notes | EFM was not used routinely and epidural analgesia was not available Dates of study: March ‐ September 2003 Funding: not reported. Conflicts of interest: The authors declare that they have no conflict of interest. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | From personal communication ‐ equal numbers of envelopes were produced for each letter (see below) and put into a box. No list of treatment allocations was created |
| Allocation concealment (selection bias) | High risk | "Allocated to one of two groups using 4‐part, block randomisation". Used "sealed envelopes labelled A, B, C, and D: envelopes A and C (intervention group) and B and D (routine care group). Patients then chose an envelope, which was opened by the investigator". Further details from personal communication ‐ the women picked from all the envelopes produced. Once an envelope was picked it was discarded. This process was open to selection bias as women previously in the trial may have shared knowledge of which envelope contained which group with women not yet enrolled in the study |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and labour room staff were not blinded to group assignment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | From personal communication "The co worker of investigator collected the outcome data and she was blind for the study group." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Medical record information was collected on 100% of the sample |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Other bias | Low risk | No other sources of bias noted |