Searching for the Perfect Oil to Protect the Perineum: A Randomized-Controlled, Double-Blind Trial

Not Applicable

• Conditions: Second Stage of Labor
• Interventions: Other: perineal massage with Wheat Germ Oil during the second stage of labor; Other: perineal massage with almond oil during the second stage of labor

• Registration Number: NCT00662974
• Lead Sponsor: Soroka University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-03
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-18
• Last Update Submitted: 2008-04-18
• Study First Posted: 2008-04-21
• Last Update Posted: 2008-04-21
• Study Start: 2008-05
• Primary Completion: 2008-12
• Study Completion: 2009-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	perineal massage with Wheat Germ Oil during the second stage of labor	parturients during the second stage of labor massaged by Wheat Germ Oil
B	perineal massage with almond oil during the second stage of labor	parturients during the second stage of labor massaged by almond oil

Primary Outcome Measures

Name	Time	Method
perineal tears vs intact perineum	after delivery

Secondary Outcome Measures

Name	Time	Method
severity of perineal tears amount of suture material required for repair suturing length	after delivery

Trial Locations

Locations (1)

Delivery Room, Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel