| Methods | Randomised trial. | |
| Participants | 3252 low-risk women booked for ANC before 22 weeks’ gestation in any of the sites participating in the study (clinics, hospitals etc) Exclusions: women with a history of complications in a previous pregnancy, with a previous low birthweight baby, medical complication (including hypertension, diabetes, psychiatric, renal or cardiac disease), < 16 or > 39 years of age, known substance abuser, weighing < 41 kg or > 100 kg, or multiple pregnancy |
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| Interventions | Reduced visits: for nulliparous women - 7 visits (at 24, 28, 32, 36, 38, 40 weeks + booking visit). Multiparous women: 6 visits (at 26, 32, 36, 38, 40 weeks + booking visit). Standard ANC: 13 visits (at 16, 20, 24, 28, 30, 32, 34, 36, 37, 38, 39, 40 weeks + booking visit) |
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| Outcomes | Women: pre-eclampsia (defined according to the criteria of the International Society for the Study of Hypertension in Pregnancy (ISSHP)), hypertension, caesarean section, undiagnosed malpresentation, IOL, length of labour, APH, PPH. Babies: perinatal death, small-for-gestational age (< 3rd centile and < 10th centile), Apgar at 1 and 5 minutes, admission to SCBU. Health service use: antenatal or day admission, number of ultrasound scans, continuity of care. Psychosocial: social support during or after pregnancy, worry about pregnancy and the well being of the fetus, attitudes to fetus and baby. Maternal and professional acceptability of the new style of care |
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| Notes | In the reduced visits group the mean number of visits was 8.6 (7 planned). In the control group the mean number of visits was 10.8 (13 planned) | |
| Risk of bias | ||
| Item | Authors’ judgement | Description |
| Adequate sequence generation? | Unclear | Random permuted blocks of 8 and 16, stratifying by the 6 offices at which the recruiting midwives were based |
| Allocation concealment? | Yes | Concealment of allocation: sequentially numbered, non-resealable opaque envelopes |
| Incomplete outcome data addressed? All outcomes |
Unclear | Loss to follow up: 68/1446 (4.7%) in reduced visits group and 30/1446 (2.1%) in the standard ANC group |