Hands on vs Hands Off for Perineal Laceration

NCT ID: NCT04860102

Last Updated: 2021-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-12-21

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.

Conditions

Perineal Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

hands on

Intervention Type: PROCEDURE

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

hands off

standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Multiple gestations
• Preterm birth

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Saccone

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gabriele Saccone

Naples, , Italy

Countries

Italy

References

Trama U, Bernardi FF, Colacurci D, Saccone G, Guida M. Hands-on vs hands-off technique at the time of delivery and postpartum pelvic floor morbidity: a secondary analysis of a randomized clinical trial. Am J Obstet Gynecol MFM. 2024 Jul;6(7):101383. doi: 10.1016/j.ajogmf.2024.101383. Epub 2024 May 21. No abstract available.

Reference Type: DERIVED

PMID: 38782091 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35697297 (View on PubMed)

Other Identifiers

13/21

Identifier Type: -

Identifier Source: org_study_id