Rogers 1998.
Methods | RCT with randomisation of individual women in balanced blocks, with allocation to 1 of 2 delivery postures within each arm | |
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) 2 arms: active management ‐ upright position (N = 374); active management ‐ supine position (N = 374)
Control: expectant management of 3rd stage (N = 764) 2 arms: expectant management ‐ upright position (N = 381); expectant management ‐ supine position (N = 383)
Data included in comparisons 1 and 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 postnatally, Hb at 24‐48 h 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 |
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 unclamped 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 study 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 we calculated SDs Dates of study: June 1993‐December 1995 Funding sources: “The study was supported by a grant from the Public Health and Operational Research Committee of the Anglia and Oxford Regional Health Authority. The NPEU is supported by the Department of Health”. Declarations of interest: not reported |
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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 study occurred when an envelope was opened. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Partly blinded. The technicians who did antenatal and postnatal blood tests were unaware of allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data available on 1507 out of 1512 at discharge (< 0.5% attrition, approximately equal losses in both groups) At 6 weeks' follow‐up < 5% attrition |
Selective reporting (reporting bias) | High risk | No study protocol found. A large number of outcomes reported but not noted in methods of paper |
Other bias | High risk |
Also:
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