Irons 1994.
| Methods | Randomised controlled trial with 3 arms, Tyneside UK. | |
| Participants | 16 women were randomised from the antenatal clinic at 34‐38 weeks of gestation. | |
| Interventions | Arm 1: nipple stimulation (n = 6). Manual, bilateral nipple stimulation for 15 minutes, starting immediately after delivery. Arm 2: routine intramuscular ergometrine 500 µg, and oxytocin 5 unit injection with delivery of the anterior shoulder (n = 3). Arm 3: no treatment (n = 5). |
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| Outcomes | The frequency of contractions. The peak placental venous pressure during contractions (mmHg). The amount of blood loss (mL). The amount of blood loss as PPH was not clearly defined by authors. Blood loss was reported as a mean only, without a standard deviation. |
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| Notes | This trial was set up to study the effects of nipple stimulation on uterine pressure, not on PPH. Exclusions included: PPH or retained placenta in a previous pregnancy; multiple pregnancy; prolonged labour (over 16 hours); anaemia; oxytocin infusion or operative delivery. 2 women in the control group had not delivered the placenta by 30 minutes and were given Syntometrin. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Randomisation took place during 2nd stage of labor..” “The participants were allocated into three type of management”. Comment: method of generation sequence not clearly specified. |
| Allocation concealment (selection bias) | Low risk | Quote: “Instructions were contained in sealed envelope, stratify parity and blocked in group of 6”. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to the nature of the intervention, blinding of the participants and personnel was not possible. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It is not clear whether or not outcomes assessors were independent and unaware of the 3 different treatments. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 of 16 initially recruited were excluded due to failed cannulation. |
| Selective reporting (reporting bias) | Low risk | Trialists reported outcomes related to uterine activity only. |
| Other bias | Low risk | None noted. |