Hands on vs Hands Off for Perineal Laceration

Not Applicable

Completed

• Conditions: Perineal Tear
• Interventions: Procedure: hands on

• Registration Number: NCT04860102
• Lead Sponsor: Federico II University

Brief Summary

Perineal trauma at the time of vaginal delivery is common, and when the anal sphincter is included, these injuries can be associated with additional morbidity including incontinence, pelvic pain and sexual dysfunction. Techniques studied include hands-on vs hands-off, perineal massage, warm compresses, Ritgen maneuver, and others. It is unclear if a hands-on technique decreases the incidence of perineal trauma compared to a hands-off technique

Detailed Description

Different strategies have been adopted in the late first and/or second stage of labor to decrease the incidence of perineal lacerations. These strategies include not only the hands-on technique, but also warm compresses, perineal massage, the use of oil or jelly, the Ritgen maneuver and a new perineal protection device. The review by Aasheim reported a decreased risk of third- and fourth-degree lacerations in the perineal massage group (two studies, RR 0.52, 95% CI 0.29 to 0.94).4 This review also showed a similar reduction in third- and fourth-degree lacerations with warm compresses (two studies, RR 0.48, 95% CI 0.28 to 0.84), but no significant changes with use of a Ritgen maneuver. Additional reviews have evaluated delayed versus immediate pushing, with no significant difference in perineal trauma.

Regarding how the interventions may work, initially the hands-on technique was hypothesized to control the velocity of the crowning process and therefore decrease perineal trauma. Given the fact that the hands-on approach has been found to be possibly associated with more perineal lacerations instead of less, some have proposed that the harm may be caused by the hands-on approach's additional pressure resulting in some perineal ischemia. Moreover, using one intervention (e.g. hands-on) may predispose to use other interventions (e.g. episiotomy), which have themselves been proven to increase perineal trauma.

Perhaps a combination of perineal interventions, such as massage or compresses, with a hands-off approach and avoidance of episiotomy, will prove to show improved perineal outcomes. Larger studies, including evaluation specific for nulliparous subjects, are required to make definitive recommendations for management.

Study Timeline

• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-26
• Study Start: 2021-05-01
• Status Verified: 2021-12
• Primary Completion: 2021-12-21
• Study Completion: 2021-12-21
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Singleton gestations
• Low risk pregnancies
• 37 to 42 weeks of gestations

Exclusion Criteria

• Multiple gestations
• Preterm birth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hands on	hands on	Hands-on was defined as involving one hand on the fetal head, applying pressure to control expulsion, with the other hand applying pressure on the maternal perineum

Primary Outcome Measures

Name	Time	Method
Incidence of Perineal laceration - any degree	at the time of delivery

Secondary Outcome Measures

Name	Time	Method
Incidence of Episiotomy	at the time of delivery

Trial Locations

Locations (1)

Gabriele Saccone; 🇮🇹 Naples, Italy