MisoREST: surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: a randomized controlled trial

被引:24
作者
Lemmers, M. [1 ,2 ]
Verschoor, M. A. C. [1 ]
Rengerink, K. Oude [1 ]
Naaktgeboren, C. [3 ]
Opmeer, B. C. [4 ]
Bossuyt, P. M. [4 ]
Huirne, J. A. F. [2 ]
Janssen, C. A. H. [5 ]
Radder, C. [6 ]
Klinkert, E. R. [7 ]
Langenveld, J. [8 ]
Catshoek, R. [9 ]
Van der Voet, L. [10 ]
Siemens, F. [11 ]
Geomini, P. [12 ]
Van Hooff, M. H. [13 ]
Van der Ploeg, J. M. [14 ]
Coppus, S. F. P. J. [15 ]
Ankum, W. M. [1 ]
Mol, B. W. J. [16 ,17 ]
机构
[1] Acad Med Ctr, Dept Obstet & Gynaecol, POB 22770, NL-1100 DE Amsterdam, Netherlands
[2] Vrije Univ Amsterdam Med Ctr, Dept Obstet & Gynaecol, POB 7057, NL-1007 MB Amsterdam, Netherlands
[3] Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, POB 85500, NL-3508 GA Utrecht, Netherlands
[4] Univ Amsterdam, Acad Med Ctr, Clin Res Unit, POB 22770, NL-1100 DE Amsterdam, Netherlands
[5] Groene Hart Hosp, Dept Obstet & Gynaecol, POB 1098, NL-2800 BB Gouda, Netherlands
[6] Onze Lieve Vrouwe Gasthuis West, Dept Obstet & Gynaecol, POB 9243, NL-1006 AE Amsterdam, Netherlands
[7] Univ Groningen, Univ Med Ctr Groningen, Dept Obstet & Gynaecol, POB 30001, NL-9700 RB Groningen, Netherlands
[8] Atrium Med Ctr, Dept Obstet & Gynaecol, POB 4446, NL-6401 CX Heerlen, Netherlands
[9] Maastricht Univ, Dept Obstet & Gynaecol, Med Ctr, POB 5800, NL-6202 AZ Maastricht, Netherlands
[10] Deventer Hosp, Dept Obstedtr & Gynaecol, POB 5001, NL-7400 GC Deventer, Netherlands
[11] Reinier de Graaf Hosp, Dept Obstet & Gynaecol, POB 5011, NL-2600 GA Delft, Netherlands
[12] Maxima Med Ctr, Dept Obstet & Gynaecol, Postbus 7777, NL-5500 MB Veldhoven, Netherlands
[13] St Franciscus Gasthuis, Dept Obstet & Gynaecol, POB 10900, NL-3004 BA Rotterdam, Netherlands
[14] Martini Hosp Groningen, Dept Obstet & Gynaecol, POB 30033, NL-9700 RM Groningen, Netherlands
[15] Radboud Univ Nijmegen Med Ctr, Dept Obstet & Gynaecol, POB 9101, NL-6500 HB Nijmegen, Netherlands
[16] Univ Adelaide, Robinson Res Inst, Sch Paediat & Reprod Hlth, 55 King William Rd, Adelaide, SA 5006, Australia
[17] South Australian Hlth & Med Res Inst, Adelaide, SA, Australia
关键词
abortion; miscarriage; uterus; surgery; expectant management; EARLY-PREGNANCY FAILURE; 1ST-TRIMESTER MISCARRIAGE; SPONTANEOUS-ABORTION; MEDICAL-MANAGEMENT; ECONOMIC-EVALUATION; MIST TRIAL; PREFERENCES; RISK; SATISFACTION; METAANALYSIS;
D O I
10.1093/humrep/dew221
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
Is curettage more effective than expectant management in case of an incomplete evacuation after misoprostol treatment for first trimester miscarriage? Curettage leads to a higher chance of complete evacuation but expectant management is successful in at least 76% of women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. In 5-50% of the women treated with misoprostol, there is a suspicion of incomplete evacuation of the uterus on sonography. Although these women generally have minor symptoms, such a finding often leads to additional curettage. From June 2012 until July 2014, we conducted a nationwide multicenter randomized controlled trial (RCT). Women who had had primary misoprostol treatment for miscarriage with sonographic evidence of incomplete evacuation of the uterus were randomly allocated to either curettage or expectant management (1:1), using a web-based application. We included 59 women in 27 hospitals; 30 were allocated to curettage and 29 were allocated to expectant management. A successful outcome was defined as sonographic finding of an empty uterus 6 weeks after randomization. Baseline characteristics of both groups were comparable. Empty uterus on sonography or uneventful clinical follow-up was seen in 29/30 women (97%) allocated to curettage compared with 22/29 women (76%) allocated to expectant management (RR 1.3, 95% CI 1.03-1.6) with complication rates of 10% versus 10%, respectively (RR 0.97, 95% CI 0.21-4.4). In the group allocated to curettage, no woman required re-curettage, while two women (6.7%) underwent hysteroscopy (for other or unknown reasons). In the women allocated to expectant management, curettage was performed in four women (13.8%) and three women (10.3%) underwent hysteroscopy. Due to a strong patient preference, mainly for expectant management, the targeted sample size could not be included and the trial was stopped prematurely. In women suspected of incomplete evacuation of the uterus after misoprostol, curettage is more effective than expectant management. However, expectant management is equally safe and prevents curettage for most of the women. This finding could further restrain the use of curettage in the treatment of first trimester miscarriage. This study was funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-82310-97-12066. There were no conflicts of interests. Dutch Trial Register NTR3310, http://www.trialregister.nl 27 February 2012. 12 June 2012.
引用
收藏
页码:2421 / 2427
页数:7
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