Vigil‐De Gracia 2013.

Methods	Randomised controlled trial (open label). 8 tertiary teaching hospitals in Latin America with experience of managing severe PE. 425 eligible women, 158 declined to participate, 267 randomised
Participants	Inclusion criteria: pregnant women between 28 and 33 weeks' gestation with severe PE, severe gestational hypertension, and super‐imposed PE Exclusion criteria: pregnant women with HELLP syndrome, renal failure, vaginal bleeding, spontaneous rupture of membranes, placenta praevia, gestational diabetes or diabetes mellitus, autoimmune disease, fetal growth restriction, reduced amniotic fluid, and reversed EDF
Interventions	Experimental intervention: delivery between 24 and 72 hrs following the administration of glucocorticoids for fetal lung maturity. Total number randomised: N = 133 Control or comparison intervention: glucocorticoid administration, then planned expectant management with delivery for maternal or fetal indications, or reaching 34 weeks. Total number randomised: N = 134 (131 analysed)
Outcomes	Primary outcome: perinatal mortality (fetal and neonatal death) Secondary outcomes: composite neonatal morbidities (RDS, IVH, necrotizing enterocolitis, neonatal sepsis); neonatal data (birthweight, SGA, Apgar scores at 1 and 5 minutes, NICU admission, length of NICU admission stay, sex (female) of baby); caesarean delivery, pregnancy prolongation, maternal morbidities (placental abruption, pulmonary edema, the HELLP syndrome, renal insufficiency, eclampsia, disseminated intravascular coagulation, oliguria), and death
Notes	Dates of the study: August 2010 to August 2012 Funding sources: Marjorie Milham Research Fund, Pennsylvania Hospital, Perelman School of Medicine, University of Pennsylvannia Declarations of interest: "The authors report no conflict of interest."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomly allocated, using computer‐generated code with variable block size of 4 and 6
Allocation concealment (selection bias)	Unclear risk	Central allocation for each hospital made by the principal investigator. Sealed envelopes were used, though does not specify whether they were sequentially numbered and opaque
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label trial due to the nature of the intervention
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	An attempt was made to blind the treatment allocation to the data abstracter ‐ especially the neonatologist. However, most outcomes depended on clinical diagnoses and others on the responses to those diagnoses.
Incomplete outcome data (attrition bias) All outcomes	Low risk	The authors stated that 2 patients did not complete the study because they refused to remain in the hospital, and 1 did not receive the correct treatment due to physician error. These 3 patients were excluded from the analysis. They said the data were not available for these 3 women. All 3 women were in the expectant management group. The authors reported that the analysis was on an ITT basis.
Selective reporting (reporting bias)	Unclear risk	The trial was registered. However, the planned secondary outcomes were listed only as "perinatal complications and maternal complications".
Other bias	Unclear risk	Baseline characteristics ‐ no differences between groups. Minimal loss to follow‐up. Two women refused to remain in hospital and one women received incorrect treatment due to physician error.

BP: blood pressure
 CP: cerebral palsy
 CS: caesarean section
 CTG: cardiotocography
 EDF: end diastolic flow
 HELLP: haemolysis, elevated liver enzymes, and lowered platelets
 HMD: hyaline membrane disease
 hrs: hours
 IM: intramuscular
 IPD: individual patient data
 ITT: intention‐to‐treat
 IUGR: intrauterine growth restriction
 MgSO4: magnesium sulphate
 NEC: necrotising enterocolitis
 NICU: neonatal intensive care unit
 PE: pre‐eclampsia
 RDS: respiratory distress syndrome
 SCBU: special care baby unit
 SGA: small‐for‐gestational age