Taavoni 2011.
Methods | Randomised trial. | |
Participants | 62 women, Tehran, Iran.
Inclusion Criteria: Parity: nulliparous, Pluralty: singleton, Gestation: 38 ‐ 40 weeks, Onset of labour: spontaneous, Other: cephalic presentation; cervical dilatation between 4 to 8 cm; anticipation of a normal birth; no history of infertility; aged 18 to 25 years. |
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Interventions |
Study group:
There were two post randomisation exclusions from the study group. Reasons included: dissatisfied with sitting on the ball during birth ball movements (n = 1); caesarean birth because of lack of descent of the fetal head (n = 1). Control group:
Routine care consists of the parturient lying on the bed without ambulating or any intervention. |
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Outcomes |
Maternal Outcomes:
Neonatal Outcomes: Nil. |
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Notes | 1. Duration of first stage labour reported as duration of active phase. 2. No mode of birth outcomes for vaginal birth or operative vaginal birth were given. If there was a need for analgesic medication, or if obstetric complications occurred, the participant was immediately referred to an obstetrician and other professionals as needed, then excluded from the study. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | 60 volunteer women (convenience sample) were randomly allocated using a table of random numbers. |
Allocation concealment (selection bias) | High risk | If the number was even, women were assigned to the birth ball group, if the number was odd, women were assigned to control group. |
Blinding (performance bias and detection bias) Women | High risk | Not feasible. |
Blinding (performance bias and detection bias) Clinical staff | High risk | Not feasible. |
Blinding (performance bias and detection bias) Outcome assessor | Low risk | The individual responsible for data analysis was masked to the study purposes to minimise any bias that might arise from knowledge about the participants. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There were two post randomisation exclusions reported: dissatisfied with sitting on the ball during birth ball movements (n = 1); caesarean birth because of lack of descent of the fetal head (n = 1). The total number of participants included for duration of labour and maternal pain data is not clearly stated. It is unclear if the number includes totals before or after exclusions. It is also not clear if the group numbers were even before or after the exclusions. |
Selective reporting (reporting bias) | Unclear risk | Unclear. |