Department of Obstetrics and Gynecology, Skåne University Hospital, Lund University, Malmö, Sweden.
Ultrasound Obstet Gynecol. 2018 Jan;51(1):24-32. doi: 10.1002/uog.18940. Epub 2017 Dec 5.
To compare vaginal misoprostol treatment with expectant management in early non-viable pregnancy with vaginal bleeding with regard to complete evacuation of the uterine cavity within 10 days after randomization.
This was a parallel randomized controlled, open-label trial conducted in Skåne University Hospital, Sweden. Patients with anembryonic pregnancy or early fetal demise (crown-rump length ≤ 33 mm) and vaginal bleeding were randomly allocated to either expectant management or treatment with a single dose of 800 μg misoprostol administered vaginally. Patients were evaluated clinically and by ultrasound until complete evacuation of the uterus was achieved (no gestational sac in the uterine cavity and maximum anteroposterior diameter of the intracavitary contents < 15 mm as measured by transvaginal ultrasound on midsagittal view). Follow-up visits were planned at 10, 17, 24 and 31 days. Dilatation and evacuation (D&E) was recommended if miscarriage was not complete within 31 days, but was performed earlier at patient's request, or if there was excessive bleeding as judged clinically. Analysis was by intention to treat. The main outcome measure was number of patients with complete miscarriage without D&E ≤ 10 days.
Ninety-four patients were randomized to misoprostol treatment and 95 to expectant management. After exclusion of three patients and withdrawal of consent by two patients in the expectant management group, 90 women were included in this group. Miscarriage was complete ≤ 10 days in 62/94 (66%) of the patients in the misoprostol group and in 39/90 (43%) of those in the group managed expectantly (risk difference (RD) = 23%; 95% CI, 8-37%). At 31 days, the corresponding figures were 81/94 (86%) and 55/90 (61%) (RD = 25%; 95% CI, 12-38%). Two patients from each group underwent emergency D&E because of excessive bleeding and one of these in each group received blood transfusion. The number of patients undergoing D&E at their own request was higher in the expectantly managed group, 15/90 (17%) vs 3/94 (3%) in the misoprostol group (RD = 14%; 95% CI, 4-23%), as was the number of patients making out-of-protocol visits, 50/90 (56%) vs 27/94 (29%) (RD = 27%; 95% CI, 12-40%). Compared with the expectant management group, more patients in the misoprostol group experienced pain (71/77 (92%) vs 91/91 (100%); RD = 8%; 95% CI, 1-17%) and used painkillers (59/77 (77%) vs 85/91 (93%); RD = 17%; 95% CI, 5-29%). No major side effect was reported in any group.
In women with early non-viable pregnancy and vaginal bleeding, misoprostol treatment is more effective than is expectant management for complete evacuation of the uterus. Both methods are safe but misoprostol treatment is associated with more pain than is expectant management. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.
比较米索前列醇阴道给药与期待管理治疗早期非存活妊娠伴阴道出血在随机分组后 10 天内子宫腔完全排空方面的效果。
这是一项在瑞典斯科讷大学医院进行的平行随机对照、开放性临床试验。将胚胎停育或胎儿早期死亡（头臀长≤33mm）伴阴道出血的患者随机分为期待管理组或阴道单次给予 800μg米索前列醇治疗组。对患者进行临床和超声评估，直至子宫完全排空（宫腔内无妊娠囊，经阴道超声测量最大宫腔内内容物前后径<15mm）。随访计划在第 10、17、24 和 31 天进行。如果 31 天内流产不完全，建议行扩宫和刮宫术（D&E），但患者要求提前进行，或出现临床判断的大量出血时也应提前进行。分析采用意向治疗。主要结局指标为 10 天内无需 D&E即可完全流产的患者人数。
94 例患者被随机分配至米索前列醇治疗组，95 例患者被分配至期待管理组。期待管理组中，3 例患者被排除，2 例患者撤回知情同意，因此共有 90 例患者纳入该组。米索前列醇组中 62/94（66%）例患者在 10 天内完全流产，而期待管理组中 39/90（43%）例患者完全流产（风险差（RD）=23%；95%CI，8-37%）。在 31 天，相应的数字分别为 81/94（86%）和 55/90（61%）（RD=25%；95%CI，12-38%）。两组各有 2 例患者因大量出血而行紧急 D&E，其中各有 1 例患者接受输血。期待管理组中有更多患者自行要求行 D&E，15/90（17%）例患者 vs 3/94（3%）例患者行米索前列醇治疗（RD=14%；95%CI，4-23%），此外，期待管理组中更多患者违反方案就诊，50/90（56%）例患者 vs 27/94（29%）例患者行米索前列醇治疗（RD=27%；95%CI，12-40%）。与期待管理组相比，米索前列醇组更多患者经历疼痛（71/77（92%）例 vs 91/91（100%）例；RD=8%；95%CI，1-17%）和使用止痛药（59/77（77%）例 vs 85/91（93%）例；RD=17%；95%CI，5-29%）。两组均未报告重大不良反应。
在早期非存活妊娠伴阴道出血的患者中，米索前列醇治疗在子宫腔完全排空方面优于期待管理。两种方法均安全，但米索前列醇治疗与期待管理相比，疼痛更常见。版权所有©2017 ISUOG。由 John Wiley & Sons Ltd 出版。
