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

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          Abstract

          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 of intravaginal 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. Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h 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 [ CI]: 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.

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          Most cited references15

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          Births: final data for 2009.

          This report presents 2009 data on U.S. births according to a wide variety of characteristics. Data are presented for maternal characteristics including age, live-birth order, race and Hispanic origin, marital status, hypertension during pregnancy, attendant at birth, method of delivery, and infant characteristics (period of gestation, birthweight, and plurality). Birth and fertility rates by age, live-birth order, race and Hispanic origin, and marital status also are presented. Selected data by mother's state of residence are shown, as well as birth rates by age and race of father. Trends in fertility patterns and maternal and infant characteristics are described and interpreted. Descriptive tabulations of data reported on the birth certificates of the 4.13 million births that occurred in 2009 are presented. Denominators for population-based rates are postcensal estimates derived from the U.S. 2000 census. The number of births declined to 4,130,665 in 2009, 3 percent less than in 2008. The general fertility rate declined 3 percent to 66.7 per 1,000 women aged 15-44 years. The teenage birth rate fell 6 percent to 39.1 per 1,000. Birth rates for women in each 5-year age group from 20 through 39 years declined, but the rate for women 40-44 years continued to rise. The total fertility rate (estimated number of births over a woman's lifetime) was down 4 percent to 2,007.0 per 1,000 women. The number and rate of births to unmarried women declined, whereas the percentage of nonmarital births increased slightly to 41.0. The cesarean delivery rate rose again, to 32.9 percent. The preterm birth rate declined to 12.18 percent; the low birthweight rate was stable at 8.16 percent. The twin birth rate increased to 33.2 per 1,000; the triplet and higher-order multiple birth rate rose 4 percent to 153.5 per 100,000.
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            Vaginal misoprostol for cervical ripening and induction of labour.

            Misoprostol (Cytotec, Searle) is a prostaglandin E1 analogue widely used for off-label indications such as induction of abortion and of labour. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
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              Cesarean section in the People’s Republic of China: current perspectives

              Objective To review the current knowledge on the prevalence, reasons, and consequences of cesarean sections in the People’s Republic of China. Methods Peer-reviewed articles were systematically searched on PubMed. The following Chinese databases were comprehensively searched: the China National Knowledge Infrastructure, Wanfang, and the VIP information. The databases were searched from inception to September 1, 2013. Two reviewers independently screened the titles and abstracts for eligibility. Full texts of eligible papers were reviewed, where relevant references were hand-searched and reviewed. Findings Sixty articles were included from PubMed, 17 articles were intentionally picked out from Chinese journals, and five additional articles were added, for a total of 82 articles for the analysis. With a current national rate near 40%, the literature consistently reported a rapid rise of cesarean sections in the People’s Republic of China in the past decades, irrespective of where people lived or their socioeconomic standing. Nonclinical factors were considered as the main drivers fueling the rise of cesareans in the People’s Republic of China. There was a lively debate on whether women’s preferences or providers’ distorted financial incentives affected the rise in cesarean sections. However, recent evidence suggests that it might be the People’s Republic of China’s health development approach – focusing on specialized care and marginalizing primary care – that is playing a role. Although 30 articles were identified studying the consequences of cesareans, the methodologies are in general weak and the themes are out of focus. Conclusion The overuse of cesareans is rising alarmingly in the People’s Republic of China and has become a real public health problem. No consensus has been made on the leverage factors that drive the cesarean epidemic, particularly for those nonclinical factors. The more macro level structural factors may have played a part, though further research is warranted to understand the mechanisms. Knowledge of the consequences of cesareans, particularly for women, is limited in the People’s Republic of China, leaving a substantial literature gap.
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                Author and article information

                Journal
                Chin Med J (Engl)
                Chin. Med. J
                CMJ
                Chinese Medical Journal
                Medknow Publications & Media Pvt Ltd (India )
                0366-6999
                20 October 2015
                : 128
                : 20
                : 2736-2742
                Affiliations
                [1 ]Department of Obstetrics and Gynecology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
                [2 ]Clinical Trial and Training Center, Shanghai Institute of Planned Parenthood Research, Shanghai 200032, China
                [3 ]Department of Obstetrics, International Peace Maternity and Children's Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, China
                [4 ]Department of Obstetrics and Gynecology, Zhongda Hospital, Medical School, Southeast University, Nanjing, Jiangsu 210009, China
                [5 ]Department of Obstetrics and Gynecology, First Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China
                [6 ]Department of Obstetrics and Gynecology, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, Sichuan 610072, China
                [7 ]Department of Obstetrics and Gynecology, First Hospital Affiliated to The Third Medical University of Chinese PLA, Chongqing 400038, China
                [8 ]Department of Biostatistics and Social Medicine, School of Public Health, Fudan University, Shanghai 200032, China
                Author notes

                Yu Zhang and Hao-Ping Zhu contributed equally to this work.

                Address for correspondence: Prof. Wen Di, Department of Obstetrics and Gynecology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 1630 Dong Fang Road, Shanghai 200127, China E-Mail: diwen163@ 123456163.com
                Article
                CMJ-128-2736
                10.4103/0366-6999.167299
                4736884
                26481739
                53a8fb95-52ed-4da4-8c3f-386f492970de
                Copyright: © 2015 Chinese Medical Journal

                This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

                History
                : 22 July 2015
                Categories
                Original Article

                cervical ripening,intravaginal,labor induction,misoprostol,placebo

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