UK 2009.
Methods | Allocation concealment: centralised automated interactive voice response system. Two arms | |
Participants | 39 singleton pregnant women with PE, defined as DBP ≥ 90 mmHg on 2 separate occasions, at least 4 hrs apart occurring after 20 weeks' gestation and associated with significant proteinuria (≥ 2 + protein on urinalysis), and women who developed superimposed PE on background chronic HT if they developed new significant proteinuria. Excluded: delivery indicated within 24 hrs, uncontrolled HT (BP > 170/110 mmHg), renal or collagen vascular disease, relative contraindications to sildenafil or taking medications that interact with sildenafil. |
|
Interventions | Exp: oral sildenafil 20 mg three times daily. (up to 80 mg a day). (19 women) Control: oral placebo of identical appearance three times daily (20 women) |
|
Outcomes | Women: prolongation of pregnancy from randomisation to delivery (days),umbilical artery pulsatility index, maternal serum urate, maternal BP, adverse events, dosing and pharmacokinetics of sildenafil in women with PE. Babies: Apgar scores, umbilical arterial and venous cord gases at delivery and placental weight, fetal adverse events. |
|
Notes | Methods for measuring BP not mentioned. Funding: funded by industry. Conflict of interests declared. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 1:1 ratio using a centralised automated interactive voice response system. Randomisation stratified by centre, gestational age (24 to 28 weeks, ≥ 28 to 34 weeks) and disease status (PE alone or PE with IUGR). |
Allocation concealment (selection bias) | Low risk | Centralised automated interactive voice response system. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind. Placebo of identical appearance. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Yes. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 4 women (10.3%) withdrew consent after randomisation (2 in each group). |
Selective reporting (reporting bias) | Low risk | Protocol registered in advance. ClinicalTrials.gov Identifier: NCT00141310. |
Other bias | High risk | Small numbers. Funded by industry. Conflict of interests declared. |