Odendaal 1990.
Methods | Described as 'randomised'. No further information. Blinding in the assessment of outcome not mentioned. Analysis ‐ ITT basis. Follow‐up ‐ 100% | |
Participants | 38 women with severe PE at 28 to 34 weeks' gestation. Severe PE defined in 4 ways, depending on BP, proteinuria, and symptoms. Women were either already admitted for bedrest and later met criteria, or admitted because of severe PE, and after 48 hrs stabilisation met entry criteria. 10 primigravidae per group Exclusions: oral antihypertensives before trial entry. Fetal or maternal complications necessitating delivery within 48 hrs (20 women excluded before randomisation for this reason) | |
Interventions | All eligible women in 48 hrs before trial entry: MgSO4 for 24 hrs. If BP 160/110 mmHg, or more, 6.25 mg dihydralazine boluses. If steroids not already given, betamethasone 12 mg IM, and again after 24 hrs Interventionist: delivery by either CS or by induction of labour, depending on obstetric circumstances. If cervix not favourable, prostaglandin E2 tablets. If still not favourable after 24 hrs, CS Expectant: bedrest on high‐risk obstetric ward, BP controlled with prazosin, weekly betamethasone. Maternal and fetal condition monitored intensively. Delivery at 34 weeks, unless indicated earlier |
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Outcomes | Women: CS, abruption Baby: stillbirth, neonatal death, HMD, NEC, pneumothorax, ventilation, days in NICU (mean), birthweight (mean), gestation at delivery (mean) | |
Notes | 8 women in the interventionist group and 5 in the expectant group deteriorated while in hospital on bedrest and were randomised immediately. Dates of the study: the trial recruited from January 1986 to January 1988 Funding sources: South African Medical Research Council Declarations of interest: none stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 58 women eligible with severe PE; 20 had to be delivered before randomisation because of severe maternal complications or fetal distress 20 were randomised to the aggressive‐management group; 18 were randomised to the expectant group – not clear from results tables how many analysed – but presume no loss to follow‐up as not described in the text ITT not stated |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported |
Other bias | Low risk | Groups seemed similar – including 20 women excluded prior to randomisation (correspondence with author) |