Department of Obstetrics and Gynecology, King Fahad Medical City, Riyadh, Saudi Arabia.
Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia.
J Gynecol Obstet Hum Reprod. 2022 Jan;51(1):102235. doi: 10.1016/j.jogoh.2021.102235. Epub 2021 Sep 25.
To conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that examined the maternal and neonatal outcomes of misoprostol+isosorbide mononitrate (ISMN) versus misoprostol alone (control) in promoting cervical ripening during labor induction.
We searched five databases from inception until 05-May-2021. We assessed risk of bias of RCTs, meta-analyzed 23 endpoints, and pooled them as mean difference or risk ratio with 95% confidence interval.
Overall, five RCTs met the inclusion criteria, comprising 850 patients (426 and 424 patients were allocated to misoprostol+ISMN and misoprostol group, respectively). Overall, the RCTs had a low risk of bias. Pertaining to maternal delivery-related outcomes, there was no significant difference between both groups regarding the mean interval from drug administration to delivery, rate of vaginal delivery, rate of cesarean section delivery, and rate of need for oxytocin augmentation. Pertaining to maternal drug-related side effects, the rate of maternal headache was significantly higher in disfavor of the misoprostol+ISMN compared with misoprostol alone. However, the rates of maternal nausea, hypotension, flushing, palpitation, dizziness, postpartum hemorrhage, and uterine tachysystole did not differ between both groups. Pertaining to neonatal outcomes, there was no significant difference between both groups regarding rates of NICU admission, meconium-stained amniotic fluid, and Apgar score <7 at five minutes.
Compared with misoprostol alone, co-administration of misoprostol+ISMN did not correlate with superior maternal delivery-related outcomes. The rate of maternal headache was significantly higher in disfavor of the misoprostol+ISMN group. There was no significant difference between both groups regarding neonatal endpoints.
系统评价和荟萃分析所有随机对照试验(RCT),以评估米索前列醇+单硝酸异山梨酯(ISMN)与单独使用米索前列醇(对照组)在引产时促进宫颈成熟的母婴结局。
我们从创建到 2021 年 5 月 5 日搜索了五个数据库。我们评估了 RCT 的偏倚风险,对 23 个终点进行了荟萃分析,并将其作为均数差或风险比与 95%置信区间进行汇总。
总体而言,有 5 项 RCT 符合纳入标准,包括 850 名患者(分别有 426 名和 424 名患者被分配到米索前列醇+ISMN 和米索前列醇组)。总体而言,这些 RCT 的偏倚风险较低。就与产妇分娩相关的结局而言,两组之间从用药到分娩的平均间隔、阴道分娩率、剖宫产率和催产素增强需求率均无显著差异。就与产妇药物相关的副作用而言,米索前列醇+ISMN 组的产妇头痛发生率明显高于米索前列醇组。然而,两组之间的产妇恶心、低血压、潮红、心悸、头晕、产后出血和子宫收缩过速发生率无差异。就新生儿结局而言,两组之间的新生儿 NICU 入院率、羊水胎粪污染率和 5 分钟时 Apgar 评分<7 的发生率均无显著差异。
与单独使用米索前列醇相比,米索前列醇+ISMN 联合使用与更好的产妇分娩相关结局无关。米索前列醇+ISMN 组产妇头痛发生率明显更高。两组之间的新生儿结局无显著差异。