阴道用单硝酸异山梨酯用于妊娠合并高血压疾病孕妇引产：一项随机对照试验。

Addition of vaginal isosorbide mononitrate for labor induction in pregnancies complicated by hypertensive diseases of pregnancy: a randomized controlled trial.

机构信息

Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH.

出版信息

Am J Obstet Gynecol MFM. 2021 Jul;3(4):100343. doi: 10.1016/j.ajogmf.2021.100343. Epub 2021 Feb 27.

DOI:10.1016/j.ajogmf.2021.100343

PMID:33652160

Abstract

BACKGROUND

Pregnancies complicated by hypertensive disease of pregnancy often require labor induction. Rates of cesarean delivery range from 15% to 60% in this population. Nitric oxide deficiency has been shown to underlay the pathophysiology of preeclampsia, and nitric oxide promotes cervical ripening.

OBJECTIVE

We hypothesized that addition of vaginal isosorbide mononitrate for labor induction could decrease the rate of cesarean delivery in pregnancies with hypertensive disease of pregnancy.

STUDY DESIGN

This study was a double-blind, placebo-controlled, randomized trial of patients with singleton pregnancy at ≥24 weeks' gestation undergoing labor induction for hypertensive diseases of pregnancy between November 2017 and February 2020. Participants were eligible if their Bishop score was <6 and if their cervical dilation was ≤2 cm. In addition, participants received up to 3 doses of 40 mg isosorbide mononitrate in addition to misoprostol for labor induction. Labor management was per healthcare provider preference. The primary outcome was rate of cesarean delivery. Secondary outcomes included the length of labor and frequency of intrapartum adverse events, including the use of intrapartum antihypertensive agents.

RESULTS

89 women were randomized to the isosorbide mononitrate group, and 87 women were randomized to the placebo group. Cesarean delivery rates were similar in both groups (32.6% vs 25.3%; relative risk, 1.29; 95% confidence interval, 0.81-2.06; P=.39). Maternal headache was increased in patients exposed to isosorbide mononitrate (42.7% vs 31%; relative risk, 1.52; 95% confidence interval, 1.04-2.23; P=.04). Clinical chorioamnionitis was increased in the placebo group (0% vs 8%; P=.02). Secondary outcomes were similar between groups.

CONCLUSION

The addition of vaginal isosorbide mononitrate for labor induction in pregnancies complicated by hypertensive disease of pregnancy did not result in fewer cesarean deliveries.

摘要

背景

妊娠合并高血压疾病常需引产，此类人群的剖宫产率为 15%至 60%。已有研究表明，一氧化氮缺乏是子痫前期病理生理学的基础，而一氧化氮可促进宫颈成熟。

目的

我们假设在妊娠合并高血压疾病患者中，阴道给予单硝酸异山梨酯引产可降低剖宫产率。

研究设计

这是一项于 2017 年 11 月至 2020 年 2 月期间进行的、针对 24 周以上、因妊娠合并高血压疾病行引产的单胎妊娠患者的双盲、安慰剂对照、随机临床试验。如果患者的 Bishop 评分<6 分且宫颈扩张≤2cm，则符合入组条件。此外，这些患者在接受米索前列醇引产的同时，还额外接受了 3 次 40mg 单硝酸异山梨酯治疗。产程管理按照医疗保健提供者的偏好进行。主要结局是剖宫产率。次要结局包括产程时间和产时不良事件的发生频率，包括使用产时降压药。

结果

89 名患者被随机分配至单硝酸异山梨酯组，87 名患者被随机分配至安慰剂组。两组剖宫产率相似（32.6% vs 25.3%；相对风险，1.29；95%置信区间，0.81-2.06；P=.39）。暴露于单硝酸异山梨酯的患者中，母体头痛发生率增加（42.7% vs 31%；相对风险，1.52；95%置信区间，1.04-2.23；P=.04）。安慰剂组的临床绒毛膜羊膜炎发生率增加（0% vs 8%；P=.02）。两组的次要结局相似。