De Aloke Kumar, Kumar Bhattacharyya Sanjoy, Chakraborty Aparna, Samanta Amrita
Department of Gynecology and Obstetrics, R G Kar Medical College, Kolkata, West Bengal, India.
Department of Community Medicine, R G Kar Medical College, Kolkata, West Bengal, India.
Obstet Gynecol Sci. 2019 Sep;62(5):313-321. doi: 10.5468/ogs.2019.62.5.313. Epub 2019 Aug 9.
To determine whether vaginal application of 40 mg isosorbide-5-mononitrate (ISMN) has a comparable cervical ripening efficacy to and lesser side effects than 400 µg misoprostol in women scheduled for the first trimester induced abortion using a manual vacuum aspirator (MVA).
We conducted a prospective randomized open-label study in 70 women at 6-12 weeks of pregnancy at the R G Kar Medical College and Hospital, Kolkata, India, over a period of two years from 2015 to 2017. Forty milligrams of ISMN and 400 µg misoprostol were vaginally applied for cervical priming. The primary outcome measure was the cervical response assessed by the passage of the appropriate and largest sized MVA cannula through the internal os without resistance, at the beginning of the procedure.
The base line cervical dilatation was found to be significantly higher in the misoprostol group than in the ISMN group (7.65±1.38 vs. 6.9±1.26 mm; =0.025, 95% confidence interval, -1.4046 to -0.953). However, when the women were sub-analyzed based on parity, there was no statistically significant difference in the same parameters among the multigravid women. The need for further cervical dilatation was significantly higher in the ISMN group when the primigravid women were compared, although the multigravid women responded favorably to ISMN.
In the primigravid women, misoprostol appears to exert a higher efficacy as a cervical ripening agent in contrast to ISMN. However, ISMN can be used in multigravid women for the same purpose as in this group, misoprostol did not show any significant improvement in efficacy over ISMN.
确定对于计划采用手动真空吸引器(MVA)进行孕早期人工流产的女性,阴道应用40毫克单硝酸异山梨酯(ISMN)与400微克米索前列醇相比,是否具有相当的宫颈成熟效果且副作用更小。
2015年至2017年期间,我们在印度加尔各答的R G Kar医学院和医院对70名妊娠6至12周的女性进行了一项前瞻性随机开放标签研究。将40毫克ISMN和400微克米索前列醇经阴道用于宫颈准备。主要结局指标是在手术开始时,通过合适且最大尺寸的MVA套管毫无阻力地通过宫颈内口来评估宫颈反应。
发现米索前列醇组的基线宫颈扩张明显高于ISMN组(7.65±1.38对6.9±1.26毫米;P = 0.025,95%置信区间,-1.4046至-0.953)。然而,当根据产次对女性进行亚组分析时,多产女性在相同参数上没有统计学显著差异。比较初孕妇时,ISMN组进一步宫颈扩张的需求明显更高,尽管多产女性对ISMN反应良好。
在初孕妇中,与ISMN相比,米索前列醇作为宫颈成熟剂似乎具有更高的疗效。然而,ISMN可用于多产女性达到相同目的,在该组中,米索前列醇在疗效上并未显示出比ISMN有任何显著改善。