BACKGROUND: Many of the individual components of antenatal care have been studied in randomised controlled trials, but few studies have compared whole programmes of antenatal care. Our aim was to test the hypothesis that a new programme of antenatal care with fewer goal-oriented visits would give an equivalent or better result in the outcomes associated with pregnancy and delivery. METHODS: In a randomised clinical trial in Harare, Zimbabwe, we compared a new programme of antenatal care with the standard programme. The new programme consisted of fewer but more objectively oriented visits and fewer procedures per visit. Seven primary care clinics were randomly assigned to the two programmes-three to the standard programme and four to the new programme. FINDINGS: Over a 2-year period, 15,994 women were recruited into the study at the time they booked antenatal care. 97% of the women were followed up, 9,394 who had followed the new programme, and 6,138 from clinics with the standard one. Women allocated to the new programme made, as planned, fewer visits than those in the standard programme (median 4 versus 6 visits, respectively). The proportion of antenatal referrals was also lower (13.6 versus 15.3%; odds ratio 0.87 (95% CI 0.79 to 0.95)) because of significantly fewer referrals for pregnancy-induced hypertension (2.5 versus 3.8%; 0.66 (0.55 to 0.79)). Nevertheless, there were significantly fewer labour referrals for severe hypertension or eclampsia (2.1 versus 2.6%; 0.81 (0.66 to 1.00)). The risk for preterm (< 37 weeks) delivery was significantly lower for women on the new programme (10.1 versus 11.5%; 0.86 (0.78 to 0.96)). There were no other significant differences between the programmes in other major indices of pregnancy outcome, including antenatal referrals for other causes, labour referrals, obstetric interventions, low birthweight, and perinatal and maternal mortality and morbidity. INTERPRETATION: An antenatal care programme with fewer more objectively oriented visits can be introduced without adverse effects on the main intermediate outcome pregnancy variables.

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