![]() ![]() We conducted this meta-analysis and systematic review using the best available evidence to assess the efficacy, efficiency, safety and patient satisfaction of double-balloon catheters in comparison with those of single-balloon devices among women who underwent labour induction with unfavourable cervixes. However, studies examining the superiority of the double-balloon catheter reveal mixed results. Given the increasing induction rate, the knowledge of even small differences between methods could be useful, not only to guide clinical practices but also to further explore the mechanism underlying the mechanical induction of labour and may promote a better understanding of the optimal methods for labour induction. Purportedly, the double-balloon (either Atad or Cook) option has an additional cervico-vaginal balloon, which applies greater pressure to both sides of the cervix and avoids the need for traction. In addition to the local effect, mechanisms that involve neuroendocrine reflexes (such as the Ferguson reflex) may promote the onset of contractions. Mechanical ripening devices apply pressure to the internal face of the cervix, directly overstretching the lower uterine segment and indirectly increasing the localised secretion of prostaglandin. Only the double-balloon catheter (either Atad or Cook) is specifically designed and licensed for labour induction, while the Foley catheter is used beyond instructions. The Cook Cervical Ripening Balloon (CCRB), which uses an identical mechanism to that of the Atad catheter, was approved by the United States Food and Drug Administration (USFDA) in 2013. In 1991, Atad described the first double-balloon variation. The original version of the Foley (single-balloon) catheter was initially described by Barnes in 1863 but was not described again until 1967, by Embrey and Mollison. The balloon catheter, including both double- and single-balloon catheters, appears to be a widely accepted mechanical method and is recommended by the WHO for the induction process. Compared with pharmacologic agents, mechanical methods, which were the first methods developed to ripen the cervix or induce labour, have similar levels of effectiveness but incur fewer episodes of adverse events (such as uterine tachysystole), have lower costs and are easier to preserve. Methods used for cervical ripening can be broadly divided into mechanical devices and pharmacologic options. ![]() If the cervix is unfavourable, no method is highly successful, and a ripening process is generally employed to obtain cervical effacement and dilatation prior to induction. Cervical status, measured by the Bishop score, is a good predictor for the outcome of labour induction. Labour induction refers to the process of artificially stimulating the uterus to begin labour, which is an increasingly common procedure. Conclusionīoth kinds of balloon catheter have similar levels of efficacy, efficiency, safety and patient satisfaction however, the single-balloon method is considered to be more cost-effective. However, heterogeneity existed for some aspects. There were no significant differences in primary outcomes (RR, 0.88 p-value, 0.43) or secondary outcomes identified between single- and double-balloon catheters. Resultsįrom a total of 1326 articles, 7 RCTs involving 1159 women were included. All statistical analyses were completed with RevMan version 5.3. The relative risks or mean differences, including their 95% confidence intervals, were calculated using fixed-effects or random-effects models. The primary outcome was the caesarean delivery rate, and the secondary outcomes focused on efficacy, efficiency, safety, and patient satisfaction. Using the population, intervention, comparison, outcomes and study designs (PICOS) principle, we searched the PubMed, EMBASE, OVID, SCI, CENTRAL,, and CDSR databases to identify relevant randomised controlled trials (RCTs) from inception through February 14, 2018. ![]() Identifying even small differences between these two devices could be useful to guide clinical practices, to further explore their mechanisms, and to promote a better understanding of the optimal methods for inducing labour. Whether the specifically designed double-balloon catheter is better than the single-balloon device in terms of efficacy, efficiency, safety and patient satisfaction remains controversial. Various methods have been used to induce labour, among which balloon catheters play an important role. The induction of labour is an increasingly common procedure in the obstetrics field. ![]()
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