Smyth Rebecca M D, Spark Patsy, Armstrong Nina, Duley Lelia
Division of Public Health, University of Liverpool, UK.
BMC Pregnancy Childbirth. 2009 Apr 14;9:15. doi: 10.1186/1471-2393-9-15.
The Magpie Trial, a randomised trial comparing magnesium sulphate with placebo for women with pre-eclampsia. This paper describes methods used for follow up in the UK, and presents additional data collected.
In the UK 774 women and their 827 children were included; excluded were women discharged without a surviving child and families who opted out. General practitioners were sent a questionnaire when the child was around 18 months old. When the child was two years, or older, questionnaires asking about the health of the women and children were posted to families. A sample of families was offered a home visit, during which the child was assessed using the Bayley Scales of Infant Development.
Of the women, 12 were lost to follow up and three died. Of the children, 12 were lost to follow up, 5 were excluded and 19 died. General practitioners returned 688/759 (91%) questionnaires, as did 619/759 (82%) women. Responses were largely comparable. 32 women had serious morbidity potentially related to pre-eclampsia. 30% of children were reported to have been admitted to hospital. There were no clear differences between the randomised groups in the child's behaviour, women's fertility or use of health service resources.
Data presented here provide further reassurance about the longer term safety of magnesium sulphate when used for women with pre-eclampsia. Postal questionnaires in the UK to assess the longer term health and wellbeing of women and children recruited to trials are feasible, and can achieve a high response rate. Responses from families and general practitioners were comparable
喜鹊试验是一项将硫酸镁与安慰剂用于子痫前期妇女的随机试验。本文描述了英国的随访方法，并展示了收集到的额外数据。
在英国，纳入了774名妇女及其827名子女；排除了没有存活子女出院的妇女和选择退出的家庭。当孩子大约18个月大时，向全科医生发送问卷。当孩子两岁或更大时，向家庭邮寄询问妇女和儿童健康状况的问卷。对一部分家庭提供了家访，在此期间使用贝利婴儿发育量表对孩子进行评估。
妇女中，12人失访，3人死亡。儿童中，12人失访，5人被排除，19人死亡。全科医生返回了688/759（91%）份问卷，妇女返回了619/759（82%）份问卷。回答在很大程度上具有可比性。32名妇女有可能与子痫前期相关的严重发病情况。据报告30%的儿童曾住院。随机分组在儿童行为、妇女生育能力或卫生服务资源使用方面没有明显差异。
本文提供的数据进一步证实了硫酸镁用于子痫前期妇女的长期安全性。在英国通过邮寄问卷评估参与试验的妇女和儿童的长期健康和幸福状况是可行的，并且可以获得很高的回复率。家庭和全科医生的回答具有可比性。
