INTRODUCTION AND HYPOTHESIS: The objective of this trial was to evaluate whether avoiding episiotomy can decrease the risk of advanced perineal tears. MATERIAL AND METHODS: In this randomized (1:1) parallel-group superiority trial, primiparous women underwent randomization into standard care (155 cases) vs. no episiotomy (154 cases) groups. The primary endpoint was the incidence of advanced (3rd- and 4th-degree) perineal tears. Secondary outcomes included perineal integrity, suturing characteristics, second-stage duration, incidence of postpartum hemorrhage, neonatal variables, and various postpartum symptoms 2 days and 2 months after delivery. RESULTS: At prespecified 1-year interim analysis, the groups did not differ in terms of baseline demographic and obstetric characteristics. Six advanced perineal tears (3.9%) were diagnosed in the standard care group vs. two in no episiotomy group (1.3%), yielding a calculated odds ratio (OR) of 0.33 [95% confidence interval (CI) 0.06-1.65). Unexpectedly, rates of episiotomy performance also did not significantly vary between groups: 26.5% (41 cases) vs. 21.4% (33 cases), respectively, p = 0.35. No significant differences were noted in any secondary outcomes. CONCLUSIONS: No difference in the rates of advanced perineal tears was found between groups; however, the main limitation of our study was unexpectedly high rates of episiotomy in the nonepisiotomy group. Thus, the main conclusion is that investigator monitoring and education should be continuously practiced throughout the trial duration, stressing the importance of adherence to the protocol.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: The objective of this trial was to evaluate whether avoiding episiotomy can decrease the risk of advanced perineal tears. MATERIAL AND METHODS: In this randomized (1:1) parallel-group superiority trial, primiparous women underwent randomization into standard care (155 cases) vs. no episiotomy (154 cases) groups. The primary endpoint was the incidence of advanced (3rd- and 4th-degree) perineal tears. Secondary outcomes included perineal integrity, suturing characteristics, second-stage duration, incidence of postpartum hemorrhage, neonatal variables, and various postpartum symptoms 2 days and 2 months after delivery. RESULTS: At prespecified 1-year interim analysis, the groups did not differ in terms of baseline demographic and obstetric characteristics. Six advanced perineal tears (3.9%) were diagnosed in the standard care group vs. two in no episiotomy group (1.3%), yielding a calculated odds ratio (OR) of 0.33 [95% confidence interval (CI) 0.06-1.65). Unexpectedly, rates of episiotomy performance also did not significantly vary between groups: 26.5% (41 cases) vs. 21.4% (33 cases), respectively, p = 0.35. No significant differences were noted in any secondary outcomes. CONCLUSIONS: No difference in the rates of advanced perineal tears was found between groups; however, the main limitation of our study was unexpectedly high rates of episiotomy in the nonepisiotomy group. Thus, the main conclusion is that investigator monitoring and education should be continuously practiced throughout the trial duration, stressing the importance of adherence to the protocol.
Authors: M C Klein; R J Gauthier; S H Jorgensen; J M Robbins; J Kaczorowski; B Johnson; M Corriveau; R Westreich; K Waghorn; M M Gelfand Journal: Online J Curr Clin Trials Date: 1992-07-01
Authors: F E M Mulder; M A Schoffelmeer; R A Hakvoort; J Limpens; B W J Mol; J A M van der Post; J P W R Roovers Journal: BJOG Date: 2012-08-20 Impact factor: 6.531