Constant Deborah, Harries Jane, Malaba Thokozile, Myer Landon, Patel Malika, Petro Gregory, Grossman Daniel
Women's Health Research Unit, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Division of Epidemiology & Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
PLoS One. 2016 Sep 1;11(9):e0161843. doi: 10.1371/journal.pone.0161843. eCollection 2016.
To document clinical outcomes and women's experiences following the introduction of mifepristone into South African public sector second-trimester medical abortion services, and compare with historic cohorts receiving misoprostol-only.
Repeated cross-sectional observational studies documented service delivery and experiences of women undergoing second-trimester medical abortion in public sector hospitals in the Western Cape, South Africa. Women recruited to the study in 2008 (n = 84) and 2010 (n = 58) received misoprostol only. Those recruited in 2014 (n = 208) received mifepristone and misoprostol. Consenting women were interviewed during hospitalization by study fieldworkers with respect to socio-demographic information, reproductive history, and their experiences with the abortion. Clinical details were extracted from medical charts following discharge. Telephone follow-up interviews to record delayed complications were conducted 2-4 weeks after discharge for the 2014 cohort.
The 2014 cohort received 200 mg mifepristone, which was self-administered 24-48 hours prior to admission. For all cohorts, following hospital admission, initial misoprostol doses were generally administered vaginally: 800 mcg in the 2014 cohort and 600 mcg in the earlier cohorts. Women received subsequent doses of misoprostol 400 mcg orally every 3-4 hours until fetal expulsion. Thereafter, uterine evacuation of placental tissue was performed as needed. With one exception, all women in all cohorts expelled the fetus. Median time-to-fetal expulsion was reduced to 8.0 hours from 14.5 hours (p<0.001) in the mifepristone compared to the 2010 misoprostol-only cohort (time of fetal expulsion was not recorded in 2008). Uterine evacuation of placental tissue using curettage or vacuum aspiration was more often performed (76% vs. 58%, p<0.001) for those receiving mifepristone; major complication rates were unchanged. Hospitalization duration and extreme pain levels were reduced (p<0.001), but side effects of medication were similar or more common for the mifepristone cohort. Overall satisfaction remained unchanged (95% vs. 91%), while other acceptability measures were higher (p<0.001) for the mifepristone compared to the misoprostol-only cohorts.
The introduction of a combined mifepristone-misoprostol regimen into public sector second-trimester medical abortion services in South Africa has been successful with shorter time-to-abortion events, less extreme pain and greater acceptability for women. High rates of uterine evacuation for placental tissue need to be addressed.
记录米非司酮引入南非公共部门中期妊娠药物流产服务后的临床结果及女性体验,并与仅接受米索前列醇的历史队列进行比较。
重复横断面观察性研究记录了南非西开普省公立医院接受中期妊娠药物流产的女性的服务提供情况及体验。2008年(n = 84)和2010年(n = 58)招募的女性仅接受米索前列醇。2014年招募的女性(n = 208)接受米非司酮和米索前列醇。同意参与的女性在住院期间由研究现场工作人员就社会人口学信息、生殖史及流产体验进行访谈。出院后从病历中提取临床细节。对2014年队列在出院后2 - 4周进行电话随访访谈以记录延迟并发症。
2014年队列接受200毫克米非司酮,在入院前24 - 48小时自行服用。对于所有队列,入院后,初始米索前列醇剂量一般经阴道给药:2014年队列为800微克,早期队列为600微克。女性随后每3 - 4小时口服400微克米索前列醇直至胎儿排出。此后,根据需要进行胎盘组织的子宫排空。除一例例外,所有队列中的所有女性均排出了胎儿。与2010年仅接受米索前列醇的队列相比(2008年未记录胎儿排出时间),米非司酮组胎儿排出的中位时间从14.5小时降至8.0小时(p<0.001)。接受米非司酮的女性更常采用刮宫或真空吸引进行胎盘组织的子宫排空(76%对58%,p<0.001);主要并发症发生率未变。住院时间和极度疼痛程度降低(p<0.001),但米非司酮队列的药物副作用相似或更常见。总体满意度保持不变(95%对91%),而与仅接受米索前列醇的队列相比,米非司酮的其他可接受性指标更高(p<0.001)。
在南非公共部门中期妊娠药物流产服务中引入米非司酮 - 米索前列醇联合方案已取得成功,流产时间更短,疼痛减轻,女性接受度更高。胎盘组织子宫排空率高的问题需要解决。