NCT00662974UnknownNot Applicable
A Randomised Double Blind Clinical Trial to Verify if Perineal Massage Increases the Chances of Delivering With an Intact Perineum Comparing the Two Oils. As Secondary Objective, we Will Evaluate the Effects of Perineal Massage on Specific Tear Location, the Severity of Perineal Tears and the Amount of Suture Material Required for Repair
Soroka University Medical Center1 site in 1 country300 target enrollmentStarted: May 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- perineal tears vs intact perineum
Study Overview
Brief Summary
In this study we intend to randomly assign each parturient one of two commonly used oils to be applied during the second stage of labor, one of them containing vitamin E. We will verify if perineal massage increases the chances of delivering with an intact perineum comparing the two oils. As secondary objectives, we will evaluate the effects of perineal massage on specific tear location, the severity of perineal tears and the amount of suture material required for repair.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Singleton pregnancy
- •Term pregnancy
Exclusion Criteria
- •Non-vertex pregnancies
- •Multiple pregnancies
- •Placenta previa
- •Placental abruption
- •Intra-uterine infection
- •Non progressive labor first stage
- •Former operations or surgical procedures in the vagina
- •Perineal massage during the weeks before labor
Outcomes
Primary Outcomes
perineal tears vs intact perineum
Time Frame: after delivery
Secondary Outcomes
- severity of perineal tears amount of suture material required for repair suturing length(after delivery)
Investigators
Study Sites (1)
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