Hands on vs Hands Off for Perineal Laceration
1 other identifier
interventional
70
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2021
CompletedFirst Posted
Study publicly available on registry
April 26, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2021
CompletedDecember 22, 2021
December 1, 2021
8 months
April 22, 2021
December 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Perineal laceration - any degree
at the time of delivery
Secondary Outcomes (1)
Incidence of Episiotomy
at the time of delivery
Study Arms (2)
hands on
EXPERIMENTALHands-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
NO INTERVENTIONstandard of care
Interventions
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
Eligibility Criteria
You may qualify if:
- Singleton gestations
- Low risk pregnancies
- to 42 weeks of gestations
You may not qualify if:
- Multiple gestations
- Preterm birth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gabriele Saccone
Naples, 80100, Italy
Related Publications (2)
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.
PMID: 38782091DERIVEDCalifano 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.
PMID: 35697297DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 22, 2021
First Posted
April 26, 2021
Study Start
May 1, 2021
Primary Completion
December 21, 2021
Study Completion
December 21, 2021
Last Updated
December 22, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share
none planned