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

Second Stage of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00662974
• Other study ID #: sor468908ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: April 17, 2008
• Last updated: April 18, 2008
• Start date: May 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2008
• Source: Soroka University Medical Center
• Contact: AVI HARLEV, MD
• Phone: 972-50-7434215
• Email: harlev[@]bgu.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Second Stage of Labor

Intervention

Other:
• perineal massage with Wheat Germ Oil during the second stage of labor
30 ml of oil applied during labor
• perineal massage with almond oil during the second stage of labor
30 ml of oil applied during labor

Locations

Country	Name	City	State
Israel	Delivery Room, Soroka University Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perineal tears vs intact perineum		after delivery	No
Secondary	severity of perineal tears amount of suture material required for repair suturing length		after delivery	No