Hands on vs Hands Off for Perineal Laceration
Primary Purpose
Perineal Tear
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
hands on
Sponsored by
About this trial
This is an interventional prevention trial for Perineal Tear
Eligibility Criteria
Inclusion Criteria:
- Singleton gestations
- Low risk pregnancies
- 37 to 42 weeks of gestations
Exclusion Criteria:
- Multiple gestations
- Preterm birth
Sites / Locations
- Gabriele Saccone
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
hands on
hands off
Arm Description
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
standard of care
Outcomes
Primary Outcome Measures
Incidence of Perineal laceration - any degree
Secondary Outcome Measures
Incidence of Episiotomy
Full Information
NCT ID
NCT04860102
First Posted
April 22, 2021
Last Updated
December 21, 2021
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT04860102
Brief Title
Hands on vs Hands Off for Perineal Laceration
Official Title
Hands on vs Hands Off for Perineal Laceration
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perineal Tear
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hands on
Arm Type
Experimental
Arm Description
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
Arm Title
hands off
Arm Type
No Intervention
Arm Description
standard of care
Intervention Type
Procedure
Intervention Name(s)
hands on
Intervention Description
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 Measure Information:
Title
Incidence of Perineal laceration - any degree
Time Frame
at the time of delivery
Secondary Outcome Measure Information:
Title
Incidence of Episiotomy
Time Frame
at the time of delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Singleton gestations
Low risk pregnancies
37 to 42 weeks of gestations
Exclusion Criteria:
Multiple gestations
Preterm birth
Facility Information:
Facility Name
Gabriele Saccone
City
Naples
ZIP/Postal Code
80100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
none planned
Citations:
PubMed Identifier
35697297
Citation
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.
Results Reference
derived
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Hands on vs Hands Off for Perineal Laceration
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