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No episiotomy versus selective lateral/mediolateral episiotomy (EPITRIAL): an interim analysis.
Sagi-Dain, Lena; Bahous, Rabia; Caspin, Orna; Kreinin-Bleicher, Inna; Gonen, Ron; Sagi, Shlomi.
Afiliación
  • Sagi-Dain L; Department of Obstetrics and Gynecology, Carmel Medical Center, 7 Michal St., Haifa, Israel. lena2303@gmail.com.
  • Bahous R; Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
  • Caspin O; Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
  • Kreinin-Bleicher I; Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
  • Gonen R; Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
  • Sagi S; Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
Int Urogynecol J ; 29(3): 415-423, 2018 03.
Article en En | MEDLINE | ID: mdl-28932882
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Canal Anal / Perineo / Laceraciones / Episiotomía / Complicaciones del Trabajo de Parto Tipo de estudio: Clinical_trials / Etiology_studies / Guideline Límite: Adult / Female / Humans / Pregnancy Idioma: En Revista: Int Urogynecol J Asunto de la revista: GINECOLOGIA / UROLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Israel Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Canal Anal / Perineo / Laceraciones / Episiotomía / Complicaciones del Trabajo de Parto Tipo de estudio: Clinical_trials / Etiology_studies / Guideline Límite: Adult / Female / Humans / Pregnancy Idioma: En Revista: Int Urogynecol J Asunto de la revista: GINECOLOGIA / UROLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Israel Pais de publicación: Reino Unido