Objective: To test the hypothesis that in nulliparous women with singleton pregnancies at term, hands-off technique during spontaneous vaginal delivery would reduce the rate of perineal laceration METHODS: Parallel group non-blinded randomized clinical trial. Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted in labor and delivery room between 37 0/7 - 42 0/7 weeks of gestation were eligible, and were randomized in a 1:1 ratio to receive hands-off technique (intervention group) or hands-on technique during pushing in the second stage of labor. The primary outcome of perineal laceration (any degree). The effect of hands-off technique on each outcome was quantified as the relative risk (RR) with 95% confidence interval (CI). Results: 70 women were enrolled in the trial. Perineal lacerations (any degree) occurred in 15/35 (42.9%) women in the intervention group, and 33/35 (94.3%) in the control group (RR 0.45, 95% CI 0.31 to 0.67). Hands-off technique was also associated with significantly decreased risk in the incidence of episiotomy (RR 0.36, 95% CI 0.14 to 0.88), first-degree (RR 0.41, 95% CI 0.20 to 0.87), and second-degree lacerations (RR 0.43, 95% CI 0.19 to 0.99). There was no significant between-group difference in third- and fourth-degree lacerations, but the trial was not powered for these outcomes. Conclusion: In nulliparous women with singleton pregnancies at term, hands-off technique reduces the rate of perineal lacerations REGISTRATION NUMBER: NCT04860102.

Hands-on vs hands-off for prevention of perineal injury: a randomized clinical trial

Califano, Gianluigi;Saccone, Gabriele;Gragnano, Elisabetta;Guida, Maurizio;Zullo, Fulvio;Locci, Mariavittoria
2022

Abstract

Objective: To test the hypothesis that in nulliparous women with singleton pregnancies at term, hands-off technique during spontaneous vaginal delivery would reduce the rate of perineal laceration METHODS: Parallel group non-blinded randomized clinical trial. Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted in labor and delivery room between 37 0/7 - 42 0/7 weeks of gestation were eligible, and were randomized in a 1:1 ratio to receive hands-off technique (intervention group) or hands-on technique during pushing in the second stage of labor. The primary outcome of perineal laceration (any degree). The effect of hands-off technique on each outcome was quantified as the relative risk (RR) with 95% confidence interval (CI). Results: 70 women were enrolled in the trial. Perineal lacerations (any degree) occurred in 15/35 (42.9%) women in the intervention group, and 33/35 (94.3%) in the control group (RR 0.45, 95% CI 0.31 to 0.67). Hands-off technique was also associated with significantly decreased risk in the incidence of episiotomy (RR 0.36, 95% CI 0.14 to 0.88), first-degree (RR 0.41, 95% CI 0.20 to 0.87), and second-degree lacerations (RR 0.43, 95% CI 0.19 to 0.99). There was no significant between-group difference in third- and fourth-degree lacerations, but the trial was not powered for these outcomes. Conclusion: In nulliparous women with singleton pregnancies at term, hands-off technique reduces the rate of perineal lacerations REGISTRATION NUMBER: NCT04860102.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/888150
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