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口服米非司酮用于促宫颈成熟和引产的安全性与有效性

Safety and Efficacy of Oral Mifepristone for Cervical Ripening and Induction of Labor.

作者信息

Pharande Pratap, Kiran Ananya R, Patel Shivani, Vanrajsinh Hada V

机构信息

Obstetrics and Gynecology, Dr. D. Y. Patil Medical College, Hospital and Research Center, Dr. D. Y. Patil Vidyapeeth, Pune (Deemed to be University), Pune, IND.

出版信息

Cureus. 2024 Jul 26;16(7):e65450. doi: 10.7759/cureus.65450. eCollection 2024 Jul.

Abstract

Background Labor induction, a common practice to prevent maternal and fetal complications from prolonged labor, involves stimulating contractions before they begin naturally. This can be achieved through medications, mechanical methods, or surgical interventions. Cervical ripening is crucial for successful delivery. When the cervix is not sufficiently ripe, drugs are often used to augment this process chemically. Objective To evaluate the safety and efficacy of mifepristone for cervical ripening and induction of labor. Method A sample size of 200 was used in this single-blind randomized control trial. Primarily, pregnant women with term pregnancies, Bishop scores <6, and cephalic fetal presentation were included in the study. The study population was randomly divided into test and control groups. The test group (n=100) was administered 200 mg of mifepristone orally, while the control group (n=100) received a placebo. The Bishop score was reassessed 24 hours after mifepristone administration. Patients were taken for labor induction if their Bishop score was >6. For individuals with a Bishop score of <6, 1 mg of dinoprostone gel was administered intracervically once every six hours. Safety and efficacy were assessed by analyzing several parameters associated with labor progression, maternal outcomes, and fetal outcomes. Results The mean age of patients in the test group was 26±4.5 years, while in the control group, it was 26±5 years. The induction-to-delivery interval was notably shorter in the test group (18.8±2.3 hours) than in the control group (19.24±1.8 hours, p<0.0001). After the administration of 200 mg mifepristone, the mean Bishop score in the test group was 5.74±0.8, compared to 5.13±0.76 in the control group. The increase in the Bishop score after mifepristone treatment was significantly higher in the test group than in the control group (p-value=0.013). In the study, 73 (73%) patients in the test group had a normal vaginal delivery (NVD), whereas NVD accounted for 64 (64%) patients in the control group. Instrumental deliveries were less frequent in the test group, accounting for 14 (14%) patients, compared to 16 (16%) patients in the control group. The frequency of lower segment cesarean section (LSCS) was also lower in the mifepristone-treated group at 13 (13%) compared to the control group at 20 (20%). Fetal distress in five (38%) patients and non-progression of labor in 11 (55%) patients were the most frequent indications for LSCS in the test and control groups, respectively. There was no significant difference in neonatal outcomes between the test and control groups. Meconium-stained liquor was the most frequent complication in both the test group (10, 10%) and the control group (5, or 5%). Conclusion Administration of mifepristone effectively increased the Bishop scores and reduced the induction-to-delivery interval compared to controls, highlighting its potential as a cervical ripening agent.

摘要

背景

引产是预防因产程延长导致母婴并发症的常见做法,包括在自然宫缩开始前刺激宫缩。这可以通过药物、机械方法或手术干预来实现。宫颈成熟对于成功分娩至关重要。当宫颈成熟度不足时,常使用药物来化学性促进这一过程。

目的

评估米非司酮用于宫颈成熟和引产的安全性和有效性。

方法

本单盲随机对照试验样本量为200。主要纳入足月妊娠、Bishop评分<6且胎儿为头先露的孕妇。研究人群随机分为试验组和对照组。试验组(n = 100)口服200 mg米非司酮,对照组(n = 100)接受安慰剂。米非司酮给药24小时后重新评估Bishop评分。Bishop评分>6的患者进行引产。对于Bishop评分<6的个体,每6小时宫颈内给予1 mg地诺前列酮凝胶。通过分析与产程进展、母亲结局和胎儿结局相关的几个参数来评估安全性和有效性。

结果

试验组患者的平均年龄为26±4.5岁,对照组为26±5岁。试验组的引产至分娩间隔(18.8±2.3小时)明显短于对照组(19.24±1.8小时,p<0.0001)。给予200 mg米非司酮后,试验组的平均Bishop评分为5.74±0.8,对照组为5.13±0.76。米非司酮治疗后试验组Bishop评分的增加显著高于对照组(p值 = 0.013)。在研究中,试验组73(73%)例患者顺产,而对照组顺产患者占64(64%)例。试验组器械助产的频率较低,为14(14%)例患者,而对照组为16(16%)例患者。米非司酮治疗组下段剖宫产(LSCS)的频率也较低,为13(13%)例,而对照组为20(20%)例。试验组和对照组分别有5(38%)例胎儿窘迫和11(55%)例产程无进展是LSCS最常见的指征。试验组和对照组的新生儿结局无显著差异。羊水粪染是试验组(10例,10%)和对照组(5例,5%)最常见的并发症。

结论

与对照组相比,米非司酮给药有效提高了Bishop评分并缩短了引产至分娩间隔,凸显了其作为宫颈成熟剂的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efd5/11344620/a5b6a7769cd4/cureus-0016-00000065450-i01.jpg

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