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. 2005 Oct 19;2005(4):CD005548. doi: 10.1002/14651858.CD005548

Netherlands 1998.

Methods Randomisation: random numbers in blocks of 10. Stratified by centre. 
 Allocation concealment: sealed, numbered, opaque envelopes. 
 Follow up: no loss to follow up (A). 
 Blinding: participants not blinded. Caregiver blinded only to urinary sodium concentration. Blinding of outcome assessment not reported.
Participants 361 women booked for midwifery care, nulliparous, DBP < 90 mmHg at booking visit before 20 weeks. Randomised if DBP > 85 x 2 in subsequent visit, or weight gain > 1 kg/week for 3 consecutive weeks, or excess oedema. Excluded if planning to leave the city or risk factors for PIH.
Interventions Low: sodium‐restricted diet, aimed at less than 50 mmol/day. Written dietary instructions given by midwife. 
 Normal: asked not to change eating habits.
Outcomes Woman: highest DBP, PE (HT (not defined) with significant proteinuria (not defined)), eclampsia, hospital referrals and admissions for HT, time to delivery, abruption, mode of delivery. 
 Baby: death, gestation at delivery (mean), birthweight, Apgar at 5 minutes, NICU admission.
Notes Multicentre study: 9 centres. 
 Setting: midwifery practices and hospital clinic. 
 Mean urinary sodium after randomisation 84 mmol/day in low sodium group, 124 mmol/day for normal diet.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate

DBP: diastolic blood pressure 
 GH: gestational hypertension 
 HT: hypertension 
 hr: hour 
 NICU: neonatal intensive care unit 
 PE: pre‐eclampsia 
 PIH: pregnancy induced hypertension 
 SGA: small‐for‐gestational age