Hands on vs Hands Off for Perineal Laceration

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

Study Overview

• Status: Completed
• Conditions: Perineal Tear
• Intervention / Treatment: Procedure: hands on

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • Gabriele Saccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Multiple gestations
• Preterm birth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Procedure: 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
NO_INTERVENTION: hands off; standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Perineal laceration - any degree	at the time of delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Episiotomy	at the time of delivery

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Califano G, Saccone G, Diana B, Colla Ruvolo C, Ioffredo D, Nappi C, Annella A, Gragnano E, Guida M, Zullo F, Locci M. 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ACTUAL): December 21, 2021
• Study Completion (ACTUAL): December 21, 2021

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (ACTUAL): April 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: 13/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: none planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No