Netherlands 1998.
Methods | Sealed numbered opaque envelopes. Blocks of 10 stratified by centre. | |
Participants | 361 women booked for midwifery care, nulliparous, DBP <90mmHg at booking visit before 20 weeks. Randomised if DBP >85 x2 in subsequent visit, or weight gain >1kg/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 50mmol/day. Written dietary instructions given by midwife. Normal: asked not to change eating habits. | |
Outcomes | Woman: highest DBP, pre‐eclampsia, eclampsia, referrals and admissions for hypertension, time to delivery, abruption, mode of delivery. Baby: gestation at delivery (mean), birthweight, Apgar at 5 minutes, paediatric admission, death. | |
Notes | Multicentre study involving 8 midwifery practices. Mean urinary sodium after randomisation 84mmol/day in low sodium group, 124mmol/day for normal diet. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |
DBP=diastolic blood pressure, PIH=pregnancy induced hypertension, PE=pre‐eclampsia, HT=hypertension