Mackrodt C, Gordon B, Fern E, Ayers S, Truesdale A, Grant A
Ipswich Hospital NHS Trust, UK.
Br J Obstet Gynaecol. 1998 Apr;105(4):441-5. doi: 10.1111/j.1471-0528.1998.tb10131.x.
To compare polyglactin 910 sutures with chromic catgut sutures for postpartum perineal repair.
A stratified randomised controlled trial, using a 2 x 2 factorial design.
The maternity unit at Ipswich Hospital NHS Trust, a district general hospital, between 1992 and 1994.
1780 women who had sustained an episiotomy or first or second degree tear following a spontaneous or simple instrumental delivery.
Policies of repair with polyglactin 910 or chromic catgut were compared. Both groups were assessed by a research midwife completing questionnaires at 24 to 48 hours and at ten days postpartum, and by self-completed questionnaires at three months after birth.
Completed questionnaires were returned for 99% of women at both 24 to 48 hours and ten days and by 93% of women three months postpartum. The two groups were similar at trial entry. Significantly fewer women allocated to the polyglactin 910 reported pain in the previous 24 hours at both 24 to 48 hours (59% vs 67%; RR 0.89, 95% CI 0.83-0.95; 2P < 0.01), and ten days (24% vs 29%; RR 0.81, 95% CI 0.69-0.95; 2P = 0.01). At three months postpartum there was no clear difference between the groups in terms of perineal pain, dyspareunia or failure to resume pain-free intercourse. More women in the polyglactin 910 group reported that some suture material had been removed (12% vs 7%; RR 1.62, 95% CI 1.19-2.21; 2P < 0.01). Three women in the polyglactin 910 group had required resuturing compared with ten in the chromic catgut group (RR 0.30; 95% CI 0.08-1.09; 2P = 0.1).
Using polyglactin 910 rather than chromic catgut for perineal repair leads to about one fewer women among every 20 having perineal pain and using analgesia ten days postpartum. Its only apparent disadvantage is that more women, again estimated as 1 in 20, report having material removed during healing. Data from this and other trials suggest that for every 100 women repaired with a polyglycolic acid-based material, about one fewer will require resuturing.
比较聚乙醇酸910缝线与铬制肠线用于产后会阴修补的效果。
采用2×2析因设计的分层随机对照试验。
1992年至1994年期间,位于伊普斯威奇医院国民保健服务信托基金的地区综合医院的产科病房。
1780名在自然分娩或简单器械助产分娩后发生会阴切开术或一度或二度撕裂的妇女。
比较使用聚乙醇酸910或铬制肠线进行修补的策略。两组均由一名研究助产士在产后24至48小时和十天时填写问卷进行评估,并在产后三个月时由产妇自行填写问卷进行评估。
在产后24至48小时和十天时,99%的妇女返回了完整的问卷,在产后三个月时,93%的妇女返回了问卷。两组在试验开始时相似。分配到聚乙醇酸910组的妇女在产后24至48小时(59%对67%;相对危险度0.89,95%可信区间0.83 - 0.95;P<0.01)和十天时(24%对29%;相对危险度0.81,95%可信区间0.69 - 0.95;P = 0.01)报告前24小时疼痛的人数明显较少。在产后三个月时,两组在会阴疼痛、性交困难或未能恢复无痛性交方面没有明显差异。聚乙醇酸910组中更多的妇女报告有一些缝线材料已被拆除(12%对7%;相对危险度1.62,95%可信区间1.19 - 2.21;P<0.01)。聚乙醇酸910组有3名妇女需要再次缝合,而铬制肠线组有10名妇女需要再次缝合(相对危险度0.30;95%可信区间0.08 - 1.09;P = 0.1)。
使用聚乙醇酸910而非铬制肠线进行会阴修补,可使每20名妇女中约少1名在产后十天出现会阴疼痛并使用镇痛药。其唯一明显的缺点是,估计每20名妇女中又有1名报告在愈合过程中有材料被拆除。来自本试验和其他试验的数据表明,每100名用聚乙醇酸基材料修补的妇女中,约少1名需要再次缝合。