Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women： A Double-blinded, Prospective Randomized Controlled Study

• Published in: Chinese medical journal Vol. 128; no. 20; pp. 2736 - 2742
• Main Authors: Zhang, Yu, Zhu, Hao-Ping, Fan, Jian-Xia, Yu, Hong, Sun, Li-Zhou, Chen, Lian, Chang, Qing, Zhao, Nai-Qing, Di, Wen
• Format: Journal Article
• Language: English
• Published: China Medknow Publications Pvt Ltd 20.10.2015; Medknow Publications and Media Pvt. Ltd; Lippincott Williams & Wilkins Ovid Technologies; Department of Obstetrics and Gynecology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China%Clinical Trial and Training Center, Shanghai Institute of Planned Parenthood Research, Shanghai 200032, China%Department of Obstetrics, International Peace Maternity and Children's Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, China%Department of Obstetrics and Gynecology, Zhongda Hospital, Medical School, Southeast University, Nanjing, Jiangsu 210009, China%Department of Obstetrics and Gynecology, First Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China%Department of Obstetrics and Gynecology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, Sichuan 610072, China%Department of Obstetrics and Gynecology, First Hospital Affiliated to The Third Medical University of Chinese PLA, Chongqing 400038, China; Medknow Publications & Media Pvt Ltd; Wolters Kluwer
• Subjects: Administration, Intravaginal; Adult; Bishop; Cervical Ripening - drug effects; Cervical Ripening; Intravaginal; Labor Induction; Misoprostol; Placebo; Cesarean section; Clinical trials; Demographic aspects; Double-Blind Method; Drug dosages; Female; Gynecology; Health aspects; Health risk assessment; Hospitals; Humans; Induced labor; Labor, Induced - methods; Medicine; Misoprostol; Misoprostol - administration & dosage; Misoprostol - therapeutic use; Obstetrics; Original; Pregnancy; Pregnancy Outcome; Pregnancy Trimester, Third; Public health; Womens health; Young Adult; 孕产妇; 安全评估; 宫颈; 引产; 成熟; 醇; 随机; China; Cervical Ripening; Misoprostol; Labor Induction; Placebo; Intravaginal
• ISSN: 0366-6999; 2542-5641
• DOI: 10.4103/0366-6999.167299

Background： In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety ofintravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods： This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7：2. lntravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h （repeated tip to 3 times） for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 1211 or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. Results： A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo （64.2% vs. 22.5%, relative risk [RR]： 2.9, 95% confidence interval [C/]： 1.4-6.0）. The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group （48.0% vs. 18.4%, RR： 2.6, 95% CI： 1.2-5.7）; and the induction-onset of labor interval was significantly shorter in the misoprostol group （P = 0.0003）. However, there were no significant differences in the median process time of vaginal labor （6.4 vs. 6.8 h; P = 0.695）, incidence （39.3% vs. 49.0%, RR： 0.8, 95% CI： 0.4-1.5） and indications （P = 0.683） of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Conclusion： Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening.