Department of Obstetrics and Gynaecology, Safdarjung Hospital, New Delhi, India.
Int J Gynaecol Obstet. 2012 Sep;118(3):205-9. doi: 10.1016/j.ijgo.2012.04.017. Epub 2012 Jun 20.
To determine the safety and effectiveness of self-administered treatment with isosorbide mononitrate (IMN) for cervical ripening in Indian women with postdated pregnancies.
A randomized, placebo-controlled study was conducted with 200 women with postdated pregnancies and unfavorable cervices who self-administered vaginally either 2 40-mg tablets of IMN or 2 40-mg tablets of pyridoxine as placebo prior to admission for induction of labor. The main outcome variables were change in Bishop score, time from admission to delivery, and presence or absence of fetal and maternal morbidity.
The Bishop score was significantly improved 24 hours after initiation of the outpatient IMN treatment (P<0.001) and the needs for further cervical ripening and oxytocin infusion were less in the study than in the control group (P<0.001 and P=0.008). The time from admission to delivery was also less (P<0.001). Moreover, the IMN treatment had no major adverse maternal or fetal effects. The vast majority of women in both groups were either satisfied or very satisfied with the outpatient treatment.
The self-administration, at home, of isosorbide mononitrate leads to a safe and effective cervical ripening prior to labor induction in women with postdated pregnancies. CTRI Registration No.:CTRI/2011/091/000121.
评估印度过期妊娠女性居家使用单硝酸异山梨酯（ISMN）进行宫颈成熟治疗的安全性和有效性。
本研究为随机、安慰剂对照试验，共纳入 200 例过期妊娠且宫颈条件不佳的孕妇，随机接受阴道内使用 2 片 40mg 的 ISMN 或 2 片 40mg 的吡哆醇（安慰剂）治疗，随后入院行引产。主要结局变量为 Bishop 评分变化、入院至分娩时间以及母婴不良事件发生情况。
ISMN 治疗开始后 24 小时，Bishop 评分显著改善（P<0.001），且研究组进一步行宫颈成熟治疗和催产素输注的需求较对照组明显减少（P<0.001 和 P=0.008）。入院至分娩时间也明显缩短（P<0.001）。此外，ISMN 治疗无明显的母体或胎儿不良影响。两组绝大多数患者对居家治疗均满意或非常满意。
对于过期妊娠孕妇，居家使用 ISMN 可安全有效地促进宫颈成熟，为引产做好准备。临床试验注册号：CTRI/2011/091/000121。
