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尼日利亚一家三级医院口服米索前列醇与手动真空吸引术治疗不全流产的随机试验

Randomised Trial of Oral Misoprostol Versus Manual Vacuum Aspiration for the Treatment of Incomplete Abortion at a Nigerian Tertiary Hospital.

作者信息

Ibiyemi Kehinde F, Ijaiya Munir'deen A, Adesina Kikelomo T

机构信息

Department of Obstetrics & Gynaecology, University of Ilorin Teaching Hospital, Ilorin, Kwara State, Nigeria.

出版信息

Sultan Qaboos Univ Med J. 2019 Feb;19(1):e38-e43. doi: 10.18295/squmj.2019.19.01.008. Epub 2019 May 30.

Abstract

OBJECTIVES

This study aimed to compare the efficacy of oral misoprostol with manual vacuum aspiration (MVA) in first trimester incomplete abortions.

METHODS

This randomised controlled trial study was conducted at the University of Ilorin Teaching Hospital, Ilorin, Nigeria between April 2014 and November 2015. Pregnant women who presented with clinical features of incomplete abortion at a gestational age of 13 weeks or less were included. Patients who had profuse vaginal bleeding, an intrauterine device , signs of pelvic infections or who were younger than 18 years old and had no accompanying adults to give informed consent were excluded. A total of 200 participants were randomly and equally allocated to either the MVA or misoprostol treatment group. The treatment group were given 600 μg of misoprostol orally. The primary outcome measure was complete uterine evacuation, while secondary outcome measures included the need for additional surgical evacuation for failed treatment, adverse effects/complications, acceptability of and satisfaction with the treatment.

RESULTS

Both misoprostol and MVA had high complete evacuation rates, yet MVA was significantly higher (99% versus 83%, relative risk [RR]: 0.84, confidence interval [CI]: 0.766-0.918; <0.001). Significantly more women in the misoprostol group required additional MVA for failed treatment than in the MVA treatment group (17% versus 1%, RR: 16.67, CI: 2.260-12.279; <0.001). No significant difference was found between the misoprostol and MVA treatment groups in terms of satisfaction (92.7% versus 89.8%, RR: 1.04, CI: 0.946-1.127; = 0.473).

CONCLUSION

Treatments with misoprostol and MVA had high complete uterine evacuation rates, as well as high rates of acceptability and satisfaction. However, MVA had a significantly higher complete evacuation rate than misoprostol.

摘要

目的

本研究旨在比较口服米索前列醇与人工负压吸引术(MVA)用于早期妊娠流产不全的疗效。

方法

本随机对照试验于2014年4月至2015年11月在尼日利亚伊洛林大学教学医院开展。纳入妊娠13周及以内出现流产不全临床特征的孕妇。排除有大量阴道出血、宫内节育器、盆腔感染体征的患者,以及年龄小于18岁且无陪同成人签署知情同意书的患者。共200名参与者被随机平均分配至MVA组或米索前列醇治疗组。治疗组口服600μg米索前列醇。主要结局指标为子宫完全排空,次要结局指标包括治疗失败后需额外手术清宫的情况、不良反应/并发症、治疗的可接受性及满意度。

结果

米索前列醇和MVA均有较高的完全排空率,但MVA的完全排空率显著更高(99%对83%,相对危险度[RR]:0.84,置信区间[CI]:0.766 - 0.918;P<0.001)。米索前列醇组因治疗失败而需要额外进行MVA的女性显著多于MVA治疗组(17%对1%,RR:16.67,CI:2.260 - 12.279;P<0.001)。米索前列醇组与MVA治疗组在满意度方面无显著差异(92.7%对89.8%,RR:1.04,CI:0.946 - 1.127;P = 0.473)。

结论

米索前列醇和MVA治疗均有较高的子宫完全排空率,以及较高的可接受性和满意度。然而,MVA的完全排空率显著高于米索前列醇。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b85d/6544063/432ea66433c0/squmj1902-e38-43f1.jpg

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