Al-Ma'ani Wael, Solomayer Erich-Franz, Hammadeh Mohamad
Department of Obstetrics and Gynaecology, University of Saarland, 66421, Homburg/Saar, Germany,
Arch Gynecol Obstet. 2014 May;289(5):1011-5. doi: 10.1007/s00404-013-3088-1. Epub 2013 Nov 16.
The aim of this study is to compare the efficacy and safety of expectant management with surgical management of first-trimester miscarriage.
This randomised prospective study was conducted in the Gynaecology Department at University of Saarland Hospital, Germany between February 2011 and April 2012. A total of 234 women were recruited following diagnosis of the first-trimester incomplete or missed miscarriage and randomised into two groups: 109 women were randomised to expectant management (group I), and 125 women to surgical management (groupII). All women were examined clinically and sonographically during the follow-up appointments at weekly intervals for up to 4 weeks as appropriate. The outcome measures were: efficacy, short-term complications and duration of vaginal bleeding and pain.
Of 234 eligible women, 17 were lost to follow-up, and the remaining 217 women were analysed. The baseline characteristics were similar in both groups. The total success rate at 4 weeks was lower for expectant than for surgical management (81.4 vs 95.7 %; P = 0.0029). The type of miscarriage was a significant factor affecting the success rate. For missed miscarriage, the success rates for expectant versus surgical management were 75 and 93.8 %, respectively. For women with incomplete miscarriage, the rates were 90.5 and 98 %. No differences were found in the number of emergency curettages between the two study groups. The duration of bleeding was significantly more in the expectant than the surgical management (mean 11 vs 7 days; P < 0.0001). The duration of pain was also more in the expectant than the surgical group (mean 8.1 vs 5.5 days; P < 0.0001). The total complication rates were similar in both groups (expectant 5.9 % vs surgical group 6.1 %; P = 0.2479). However, the pelvic infection was significantly lower in the expectant than the surgical group (1.9 vs 3.5 %, respectively; P = 0.0146).
Expectant management of clinically stable women with first-trimester miscarriage is safe and effective and avoids the need for surgery and the subsequent risk of anaesthesia in about 81.4 % of cases, and has lower pelvic infection rate than surgical curettage. However, surgical management is more successful, and with a shorter duration of bleeding and pain. Therefore, the patient's preference should be considered in the counselling process.
本研究旨在比较孕早期流产期待治疗与手术治疗的疗效和安全性。
这项随机前瞻性研究于2011年2月至2012年4月在德国萨尔兰大学医院妇科进行。共招募了234名诊断为孕早期不全流产或稽留流产的妇女,并随机分为两组:109名妇女随机分配至期待治疗组(I组),125名妇女分配至手术治疗组(II组)。所有妇女在随访期间每周进行临床和超声检查,酌情持续4周。观察指标包括:疗效、短期并发症、阴道出血持续时间和疼痛持续时间。
234名符合条件的妇女中,17名失访,其余217名妇女纳入分析。两组的基线特征相似。期待治疗组4周时的总成功率低于手术治疗组(81.4%对95.7%;P = 0.0029)。流产类型是影响成功率的重要因素。对于稽留流产,期待治疗与手术治疗的成功率分别为75%和93.8%。对于不全流产妇女,成功率分别为90.5%和98%。两组间急诊刮宫次数无差异。期待治疗组的出血持续时间显著长于手术治疗组(平均11天对7天;P < 0.0001)。期待治疗组的疼痛持续时间也长于手术治疗组(平均8.1天对5.5天;P < 0.0001)。两组的总并发症发生率相似(期待治疗组5.9%对手术治疗组6.1%;P = 0.2479)。然而,期待治疗组的盆腔感染率显著低于手术治疗组(分别为1.9%对3.5%;P = 0.0146)。
对临床稳定的孕早期流产妇女进行期待治疗是安全有效的,约81.4%的病例可避免手术及后续麻醉风险,且盆腔感染率低于手术刮宫。然而,手术治疗更为成功,出血和疼痛持续时间更短。因此,在咨询过程中应考虑患者的偏好。