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

Gianluigi Califano; Gabriele Saccone; Bianca Diana; Claudia Collà Ruvolo; Daniela Ioffredo; Carmen Nappi; Antonella Annella; Elisabetta Gragnano; Maurizio Guida; Fulvio Zullo; Mariavittoria Locci

doi:10.1016/j.ajogmf.2022.100675

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

Am J Obstet Gynecol MFM. 2022 Sep;4(5):100675. doi: 10.1016/j.ajogmf.2022.100675. Epub 2022 Jun 10.

Affiliations

¹ Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.
² Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy. Electronic address: elisabettagragnano@gmail.com.

PMID: 35697297
DOI: 10.1016/j.ajogmf.2022.100675

Abstract

Background: Perineal trauma after vaginal delivery is common and is associated with severe morbidity, including incontinence, pelvic pain, and sexual dysfunction. Morbidity is mainly related to third- or fourthdegree lacerations.

Objective: This study aimed to test the hypothesis that in nulliparous women with singleton pregnancies at term, hands-off technique during spontaneous vaginal delivery could reduce the rate of perineal laceration.

Study design: This was a parallel-group, nonblinded, randomized clinical trial. Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted to the labor and delivery room between 37 0/7 and 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 was perineal laceration (any degree). The effect of hands-off technique on each outcome was quantified as relative risk with 95% confidence interval.

Results: A total of 70 women were enrolled in the trial. Perineal lacerations (any degree) occurred in 15 of 35 (42.9%) women in the intervention group and 33 of 35 (94.3%) women in the control group (relative risk, 0.45; 95% confidence interval, 0.31-0.67). Hands-off technique was also associated with significantly decreased incidence of episiotomy (relative risk, 0.36; 95% confidence interval, 0.14-0.88), first-degree lacerations (relative risk, 0.41; 95% confidence interval, 0.20-0.87), and second-degree lacerations (relative risk, 0.43; 95% confidence interval, 0.19-0.99). 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.

Trial registration: ClinicalTrials.gov NCT04860102.

Keywords: incontinence; pelvic organ prolapse; perineal laceration; urology.

Publication types

Randomized Controlled Trial

MeSH terms

Delivery, Obstetric / adverse effects
Delivery, Obstetric / methods
Episiotomy / adverse effects
Female
Humans
Lacerations* / diagnosis
Lacerations* / epidemiology
Lacerations* / etiology
Male
Perineum / injuries
Pregnancy
Urinary Incontinence* / complications

Associated data

ClinicalTrials.gov/NCT04860102