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

• Sponsor: Soroka University Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00662974
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 30

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Second Stage of Labor	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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• 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
• Study Start Date: May 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2008
• Anticipated Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A parturients during the second stage of labor massaged by Wheat Germ Oil	Other: perineal massage with Wheat Germ Oil during the second stage of labor; 30 ml of oil applied during labor
Experimental: B parturients during the second stage of labor massaged by almond oil	Other: perineal massage with almond oil during the second stage of labor; 30 ml of oil applied during labor

Outcome Measures

Primary Outcome Measures

1. perineal tears vs intact perineum [after delivery]

Secondary Outcome Measures

1. severity of perineal tears amount of suture material required for repair suturing length [after delivery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Delivery Room, Soroka University Medical Center	Beer Sheva		Israel

Sponsors and Collaborators

• Soroka University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00662974
• Other Study ID Numbers: sor468908ctil
• First Posted: Apr 21, 2008
• Last Update Posted: Apr 21, 2008
• Last Verified: Mar 1, 2008

Study Results

No Results Posted as of Apr 21, 2008