米索前列醇联合与不联合甲麦角新碱和缩宫素用于门诊药物流产的比较：一项 III 期随机对照试验。

A comparison of misoprostol with and without methylergometrine and oxytocin in outpatient medical abortion: a phase III randomized controlled trial.

机构信息

Obstetrics and Gynecologist, Departments of Obstetrics and Gynecology, Jahrom University of Medical Sciences, Jahrom, Iran.

Department of Public Health, Torbat Jam Faculty of Medical Sciences, Torbat Jam, Iran.

出版信息

BMC Res Notes. 2023 Oct 5;16(1):257. doi: 10.1186/s13104-023-06509-6.

DOI:10.1186/s13104-023-06509-6

PMID:37798748

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10557307/

Abstract

OBJECTIVE

The complications associated with miscarriages have surfaced as a major concern in maintaining women's physical and mental health. The present study evaluated the efficacy of three medication regimes for the complete expulsion of retained intrauterine tissues in patients who underwent a miscarriage.

METHODS

In this randomized clinical trial, 90 patients participated with their gestational age below 12 weeks, each having undergone a recent miscarriage. After being screened for underlying diseases and coagulative blood disorders, they were randomly allocated into three groups. For the first group, labeled as the control group, misoprostol was administered alone. In contrast, the combination of misoprostol plus methylergometrine and misoprostol plus oxytocin was prescribed for the second and third groups, respectively. Further, the data obtained were analyzed by descriptive and inferential statistics using Stata software version 14.

RESULTS

The mean age of participants and gestational age were 29.76 ± 5.53 years and 8.23 ± 2.29 weeks, respectively. There was no significant difference between the three treatment groups regarding the amount of bleeding after the abortion(P = 0.627). Regarding pain severity, the group that received Misoprostol plus Methylergometrine had less pain intensity than the other two groups(p = 0.004). The mean rate of RPOC expulsion was in the Misoprostol plus Oxytocin (9.68 ± 10.36) group, Misoprostol plus Methylergometrine (11.73 ± 12.86), and Misoprostol groups (19.07 ± 14.31)(p = 0.013). The success rate in outpatient medical abortion in the misoprostol plus oxytocin and misoprostol plus methylergonovine group was 93.33%, but in patients treated by misoprostol alone was 83.33%.

CONCLUSION

The effectiveness of the drugs in the two drug groups combined with oxytocin and methylergometrine is higher than the misoprostol group alone. An outpatient approach was deemed more satisfactory against surgical maneuvers and hospitalizations by patients since family support influenced their pain coping mechanism.

TRIAL REGISTRATION

The trial was registered in the Iranian registry of clinical trials on 04/10/2019. ( https://fa.irct.ir/trial/34519 ; registration number: IRCT20150407021653N19).

摘要

目的

流产相关并发症已成为维护妇女身心健康的主要关注点。本研究评估了三种药物治疗方案在流产后完全排出宫内残留组织的效果。

方法

在这项随机临床试验中，90 名年龄在 12 周以下的患者参与了研究，他们都经历了最近的流产。在筛查潜在疾病和凝血障碍后，他们被随机分为三组。第一组为对照组，单独给予米索前列醇。相比之下，第二组和第三组分别给予米索前列醇联合麦角新碱和米索前列醇联合催产素。进一步使用 Stata 软件版本 14 对获得的数据进行描述性和推断性统计分析。

结果

参与者的平均年龄和妊娠年龄分别为 29.76±5.53 岁和 8.23±2.29 周。三组患者流产后出血量无显著差异（P=0.627）。关于疼痛严重程度，接受米索前列醇加麦角新碱的组比其他两组疼痛强度更小（p=0.004）。米索前列醇联合催产素（9.68±10.36）、米索前列醇联合麦角新碱（11.73±12.86）和米索前列醇组（19.07±14.31）的 RPOC 排出率分别为（p=0.013）。米索前列醇加催产素和米索前列醇加麦角新碱组的门诊药物流产成功率为 93.33%，而单独使用米索前列醇组为 83.33%。