Thank you for publishing an article about the concept of early amniotomy in nulliparous labor induction. It is really a special interest topic in the field of obstetrics that most of us considerably encounter in clinical practice every day. I also congratulate all the authors who contributed to this successfully and rationally designed article. However, there seems to be something wrong with the statistical analysis performed in the study.
According to the statistical analysis, nearly 290 well-randomized patients who experienced normal spontaneous vaginal delivery were needed to complete the research. However, in Table 3, approximately 40% of both the early amniotomy and standard therapy groups had undergone cesarean delivery. This means that nearly 60% of 290 patients (calculated as approximately 177 patients) experienced normal spontaneous vaginal delivery, which is not enough in terms of patient number to calculate perfectly according to the methods of this study; as mentioned, they needed 290 patients who had undergone spontaneous delivery per group. Also, 22 women who were assigned randomly to early amniotomy group experienced rupture at >4 cm of cervical dilation, and 13 women who were assigned randomly to standard treatment group experienced rupture at <4 cm of cervical dilation.
As all we know, early spontaneous rupture of membranes occurs naturally without any control. However, in my opinion, if the rupture of membranes is spontaneous then you should exclude these cases according to the study design; iatrogenic and full controlled amniotomy had been performed to all other patients.
In conclusion, I suggest that the authors should better perform the statistical analysis of this study anew according to the new sample size because it will be smaller. The delivery time and proportion of induced nulliparous women who deliver within 24 hours will probably be different and possibly statistically insignificant. Also, the neonatal outcomes will be different from the present results with the calculation for 177 patients. I hope this unfortunate error in this well-designed randomized trial will be addressed in order to prevent other major misconceptions.