Slunska P, Hanacek J, Fanta M, Sehnal B, Gerychová R, Hola A, Zdenkova A, Neumannová H, Dziakova M, Lubusky M
Ceska Gynekol. 2017 Fall;82(5):336-344.
In the Czech Republic (CR), it is possible, to carry out Medical Termination of Pregnancy (MToP) in the 1st trimester since June 2014, in case a woman submits a written request for it and in case the ultrasound examination confirms an intrauterine singleton prosperous pregnancy, between day 42 and 49 of gestation, crown-rump length (CRL) of the embryo 2-9 mm. The aim of the study is to analyze the management of MToP up until the 7th week of gestation in five centres in the CR.
Multicenter cohort (prospective) study.
Department of Obstetrics and Gynecology, Palacky University Olomouc, Faculty of Medicine and Dentistry, University Hospital Olomouc; The Institute for the Care of Mother and Child, Charles University in Prague, Third faculty of Medicine; Department of Gynecology and Obstetrics, Charles University in Prague, First faculty of Medicine, General University Hospital in Prague; Department of Gynecology and Obstetrics, Charles University in Prague, First faculty of Medicine, Hospital Na Bulovce, Prague; Department of Gynecology and Obstetrics, Masaryk University, Faculty of Medicine, University Hospital Brno.
In 2014-2016, a total of 1820 pregnant women requested MToP. The diagnosis of an intrauterine singleton prosperous pregnancy was set by transvaginal ultrasound, CRL 2-9 mm. MToP was carried out by combination of mifepristone (600 mg orally) and misoprostol (400 mcg orally) within 48 hours. MToP follow up (exclusion of ongoing pregnancy) after 2-3 weeks was carried out by transvaginal ultrasound as well.
In 11.0% of women (201/1820) who requested MToP, CRL > 9 mm, unprosperous, multiple or ectopic pregnancy was diagnosed. In the remaining 1619 women MToP was carried out, but in 221 cases (13.7%) at least one additional pre-first visit was needed before the diagnosis of intrauterine singleton prosperous pregnancy CRL 2-9 mm could be established, in 19 cases (1.2%) two pre-first visits and in 5 cases (0.3%) even three. Gestational age was 42-49 days (average 47.1, median 47), the women were 14-47 years of age (average 30.7, median 30). In 20.8% of women (336/1619) MToP follow up was missed and of the remaining 1283 women, ongoing pregnancy (MToP failure) was diagnosed in 1.6% (24/1283), incomplete abortion in 6.5% (83/1283) and complete abortion in 91.9% (1179/1283). A subsequent surgical intervention was carried out in 7.1 % of women (91/1283).
A medical facility performing MToP in the 1st trimester should develop its own methodology in accordance with the legislation in force, Summaries of Product Characteristics, and recommendations of professional associations. The methodology should also include a method of evaluation of the result and management. The subsequent surgical intervention should only be performed in indicated cases. The main goal of MToP follow up is to exclude ongoing pregnancy (MToP failure), and the patient should be informed in detail about the risks involved and possibilities of their solution, it is necessary to obtain an informed consent.
在捷克共和国(CR),自2014年6月起,如果女性提交书面申请,且超声检查确认宫内单胎妊娠发育正常,妊娠42至49天,胚胎头臀长(CRL)为2 - 9毫米,则可以在孕早期进行人工终止妊娠(MToP)。本研究的目的是分析CR五个中心在妊娠第7周之前的MToP管理情况。
多中心队列(前瞻性)研究。
奥洛穆茨帕拉茨基大学医学院和牙科学院妇产科、奥洛穆茨大学医院;布拉格查理大学医学院第三附属医院母婴护理研究所;布拉格查理大学医学院第一附属医院妇产科、布拉格综合大学医院;布拉格查理大学医学院第一附属医院妇产科、布拉格纳布卢夫采医院;布尔诺马萨里克大学医学院妇产科、布尔诺大学医院。
2014 - 2016年,共有1820名孕妇申请MToP。经阴道超声诊断为宫内单胎妊娠发育正常,CRL为2 - 9毫米。MToP在48小时内通过米非司酮(口服600毫克)和米索前列醇(口服400微克)联合进行。2 - 3周后的MToP随访(排除持续妊娠)也通过经阴道超声进行。
在申请MToP的女性中,11.0%(201/1820)被诊断为CRL > 9毫米、发育异常、多胎或异位妊娠。其余1619名女性进行了MToP,但在221例(13.7%)中,在确诊宫内单胎妊娠发育正常CRL为2 - 9毫米之前至少需要额外进行一次首次就诊前检查,19例(1.2%)需要两次首次就诊前检查,5例(0.3%)甚至需要三次。妊娠年龄为42 - 49天(平均47.1天,中位数47天),女性年龄为14 - 47岁(平均30.7岁,中位数30岁)。20.8%(336/1619)的女性错过MToP随访,在其余1283名女性中,1.6%(24/1283)被诊断为持续妊娠(MToP失败),6.5%(83/1283)为不全流产,91.9%(1179/1283)为完全流产。7.1%(91/1283)的女性随后进行了手术干预。
在孕早期进行MToP的医疗机构应根据现行法律、产品特性摘要和专业协会的建议制定自己的方法。该方法还应包括结果评估和管理方法。后续手术干预仅应在特定情况下进行。MToP随访的主要目标是排除持续妊娠(MToP失败),应详细告知患者所涉及的风险及其解决可能性,必须获得知情同意。