Bryce R L, Stanley F J, Garner J B
Department of Obstetrics & Gynaecology, Flinders Medical Centre, Bedford Park, South Australia.
Br J Obstet Gynaecol. 1991 Oct;98(10):1001-8. doi: 10.1111/j.1471-0528.1991.tb15338.x.
To test the effect of a programme of additional antenatal social support on the occurrence of preterm birth (a birth from 20 to 36 weeks gestation) in women at risk of preterm birth.
A prospective randomized controlled trial. The design was one of randomization before consent for a new treatment.
Three public hospital antenatal clinics in Perth and the offices of 87 obstetricians and general practitioners in Western Australia.
1970 pregnant women with poor obstetric histories entered the trial; 983 of these were randomly allocated to the programme group and 987 to the control group.
Normal antenatal care was provided for both groups. In addition, members of the programme group were offered an intervention aimed at providing expressive (emotional) social support, consisting of antenatal home visits and telephone calls by midwives. Of the women allocated to the programme group, 24 refused consent and 69 were not traced before completion of their pregnancies, the remaining 890 women (90.5%) agreed to enter the programme, and each received at least one intervention.
Gestational age at completion of the pregnancy. A pregnancy ending before 20 weeks was labelled a miscarriage.
There were 126/981 (12.8%) preterm births in the programme group and 147/986 (14.9%) in the control group. The outcome data for two women in the programme group and one in the control group could not be found. The unadjusted odds ratio for preterm birth in the programme was 0.84 (95% CI 0.65-1.09). The observed relative reduction in preterm births associated with the programme was 13.8% (95% CI -8.2% to +31.5%) and the trial had a 60% power to exclude a true relative reduction of 25%.
The results of this trial and those of other controlled clinical trials provide little evidence for the effectiveness of social support interventions in the prevention of preterm birth in women with poor obstetric histories.
测试一项额外的产前社会支持项目对有早产风险的女性发生早产（妊娠20至36周分娩）的影响。
一项前瞻性随机对照试验。该设计为在同意接受新治疗前进行随机分组。
珀斯的三家公立医院产前诊所及西澳大利亚州87位产科医生和全科医生的办公室。
1970名有不良产科病史的孕妇进入试验；其中983名被随机分配至项目组，987名被分配至对照组。
两组均提供常规产前护理。此外，项目组的成员接受了旨在提供表达性（情感）社会支持的干预，包括产前家访和助产士电话随访。在分配至项目组的女性中，24名拒绝同意，69名在妊娠结束前未被追踪到，其余890名女性（90.5%）同意参加该项目，且每人至少接受了一次干预。
妊娠结束时的孕周。妊娠在20周前结束被标记为流产。
项目组有126/981（12.8%）例早产，对照组有147/986（14.9%）例早产。项目组两名女性和对照组一名女性的结局数据未找到。项目组早产的未调整优势比为0.84（95%可信区间0.65 - 1.09）。观察到与该项目相关的早产相对减少率为13.8%（95%可信区间 - 8.2%至 + 31.5%），该试验有60%的把握度排除真实相对减少率为25%的情况。
该试验及其他对照临床试验的结果几乎没有证据表明社会支持干预对预防有不良产科病史女性的早产有效。
