Methods | RCT with randomisation of individual women in balanced blocks, with allocation to 1 of 2 delivery postures within each arm | |
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Participants |
UK hospital setting. High-income country. Inclusion criteria: 1512 women at low risk of PPH giving birth at study hospital (including water births). Exclusion criteria: placenta praevia, previous PPH, APH after 20 weeks’ gestation, Hb <10 g/dL or MCV < 75 fL, non-cephalic presentation, multiple pregnancy, intrauterine death, epidural anaesthesia, parity > 5, uterine fibroid, oxytocin augmentation infusion, anticoagulation therapy, intended instrumental or OVB, duration of gestation < 32 weeks, (plus any other contraindication, in clinician’s view) |
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Interventions |
Intervention: active management of 3rd stage (N = 748). Two arms: active management - upright position (N = 374); Active management - supine position (N = 374):
Control: expectant management of 3rd stage (N = 764). Two arms: expectant management - upright position (N = 381); expectant management - supine position (N = 383):
Data included in Comparisons 1 & 2. |
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Outcomes | Pre-specified outcomes: PPH (> 500 mL) as assessed/estimated by the attending MW (used for power calculation); severe PPH 1000 mL), blood transfusion, iron tablets post-natally, Hb at 24-48 hours P/N, self-completed questionnaire on maternal fatigue and depression at 6 weeks P/N, nausea, vomiting, headache, hypertension, manual removal of placenta, ERPC, neonatal outcomes, views of mothers and staff | |
Notes |
High-income setting Actual management used in the active arm: 699 (93.4%) had full active management; 95% given prophylactic uterotonic before delivery of placenta; 93% cord clamped before pulsation ceased; 46% CCT; 44% upright Actual management used in the expectant arm: 488 (63.9%) had full expectant management; 21% received oxytocic for treatment, and 2.5% prophylactically; cord left un-clamped till pulsation ceased 70%; placenta delivered by CCT 12%; 43% upright The setting is described as one where the midwives were “similarly confident” in active and expectant management. However, the questionnaire administered to 92 of the 153 midwives prior to the trial commencement showed that, whereas 84% felt “very confident” of active management, only 41% were “very confident” of expectant management Maternal mean Hb levels were reported with SEs and so SDs were calculated |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Variable sized balanced blocks “…randomisation envelopes were prepared in advance.." in an external academic unit -National Perinatal Epidemiology Unit, Oxford |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, opaque, sealed envelopes stored on the ward. Entry to the trial occurred when an envelope was opened |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data available on 1507 out of 1512 at discharge (less than 0.5% attrition, approximately equal losses in both groups) At 6 weeks follow-up less than 5% attrition. |
Selective reporting (reporting bias) | Unclear risk | Both significant and non-significant results presented but we have not been able to check the trial protocol. Most as above reported plus others. Only a few neonatal outcomes reported |
Other bias | Low risk | Initial power calculation suggested a sample size of 2000. Interim analysis showed a higher PPH rate than expected, so sample size was revised to 1500 and the trial stopped earlier than expected once the recalculated sample size was reached - no suggestion of bias |