Hands on vs Hands Off for Perineal Laceration

Sponsor

Federico II University (Other)

Overall Status

Completed

CT.gov ID

NCT04860102

Collaborator

(none)

Enrollment

Location

Arms

7.7

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Perineal Tear	Procedure: hands on	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Hands on vs Hands Off for Perineal Laceration

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Dec 21, 2021

Actual Study Completion Date :

Dec 21, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of Perineal laceration - any degree [at the time of delivery]

Secondary Outcome Measures

Incidence of Episiotomy [at the time of delivery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Singleton gestations
Low risk pregnancies
37 to 42 weeks of gestations

Exclusion Criteria:

Multiple gestations
Preterm birth

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gabriele Saccone	Naples		Italy	80100

Sponsors and Collaborators

Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gabriele Saccone, Principal Investigator, Federico II University

ClinicalTrials.gov Identifier:

NCT04860102

Other Study ID Numbers:

13/21

First Posted:

Apr 26, 2021

Last Update Posted:

Dec 22, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lacerations

Study Results

No Results Posted as of Dec 22, 2021