Perineal Lacerations Clinical Trial
Official title:
Modified Ritgens Maneuver for Perineal Protection at Delivery
Verified date | April 2008 |
Source | Lund University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
The aim of the investigation was to assess whether routine use of the modified Ritgen´s maneuver decreases the risk of anal sphincter injury at delivery, compared with simple manual protection of the perineum.Ritgen´s maneuver means that the fetal chin is reached for between the anus and the coccyx and pulled anteriorly, while using the fingers of the other hand on the fetal occiput to control speed of delivery and keep flexion of the fetal neck.
Status | Completed |
Enrollment | 1623 |
Est. completion date | July 2001 |
Est. primary completion date | July 2001 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 44 Years |
Eligibility |
Inclusion Criteria: - Women with singleton pregnancy and a fetus in cephalic presentation - admitted for labor - rupture of the membranes or induction after 37 completed gestational weeks - and reaching full cervical dilatation. Exclusion Criteria: - Operative delivery |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Sweden | Helsingborgs lasarett | Helsingborg | |
Sweden | Lund Univeristy Hospital | Lund |
Lead Sponsor | Collaborator |
---|---|
Lund University Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perineal rupture grade III-IV (anal sphincter tears) | At delivery - within minutes - hours of randomization | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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