Mesbah 2003.
Methods | Randomisation was generated from a random number sequence table. Blind allocation was made using consecutively sealed envelopes. Odd numbers = aggressive management, even numbers = expectant management. Analysis was by ITT. Follow‐up was judged to be 100%. | |
Participants | 30 pregnant women with severe PE between 28 and 33 + 6 days gestation. Severe PE was defined as a BP > 180/120 mmHg on 2 occasions, 30 minutes apart; or a BP between 160 to 180/110 to 120 mmHg on 2 occasions, 6 hrs apart. All participants had > 500 mg of proteinuria on a 24 hr urine collection measure. Exclusions were women who needed delivery for either a maternal or fetal condition in the 1st 24 hrs. | |
Interventions | The group assigned to aggressive management were given steroids, and then allowed 48 hrs to lapse before either an induction of labour was attempted or CS carried out. Women assigned to expectant management also had steroids, but were then managed conservatively with bedrest, observations, and nifedipine to control their BP. The indications for delivery in expectant management were: imminent eclampsia, deteriorating renal function, spontaneous preterm labour, absent EDF, or a non‐reassuring CTG, and reaching 34 weeks. | |
Outcomes | Women: days of hospitalisation, imminent eclampsia, eclampsia, HELLP, CS, imminent eclampsia and deteriorating renal function Baby: days gained in utero, gestation at delivery, birthweight, admission to SCBU, SGA, stillbirth, neonatal death, 5‐minute Apgar score |
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Notes | In table 2, the total number in the expectant arm was recorded as 10 participants, however, the detail of the table and percentages use the denominator 15. The total looked as if it was a typographical error. We are seeking information from the author. Dates of the study: January 2001 and May 2002 Funding sources: none disclosed Declarations of interest: none disclosed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Random sequence generated by going through random number tables till we obtained 30 pairs of numbers from 01 to 30.” |
Allocation concealment (selection bias) | Low risk | “Randomly assigned to one of two management groups by withdrawing the next envelope in a series of 30 consecutively numbered, sealed, opaque envelopes.” |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No blinding reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | 41 women were recruited, but 11 (27%) judged too compromised for expectant management, and were delivered by CS 5 patients from the expectant group appeared to be missing from results table 2 – no explanation |
Selective reporting (reporting bias) | Low risk | All expected outcomes appear to be reported |
Other bias | High risk | Severe group were excluded from the study, and no baseline characteristics described for this group of patients. 5 patients missing from results for expectant group and no explanation given in the text |