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

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00662974

Purpose

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	Intervention
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

Drug Information available for: Almond oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment
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

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:

perineal tears vs intact perineum [ Time Frame: after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

severity of perineal tears amount of suture material required for repair suturing length [ Time Frame: after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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
B: Experimental 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

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662974

Contacts

Contact: AVI HARLEV, MD

972-50-7434215

harlev@bgu.ac.il

Locations

Israel
Delivery Room, Soroka University Medical Center
BEER SHEVA, Israel

Sponsors and Collaborators

Soroka University Medical Center

More Information

No publications provided

Responsible Party:	OBGYN A DEPARTMENT, Soroka University Medical Center ( Avi Harlev, MD )
Study ID Numbers:	sor468908ctil
Study First Received:	April 17, 2008
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00662974 History of Changes
Health Authority:	Israel: Ethics Commission

Study placed in the following topic categories:

Lacerations
Neoplasm Metastasis

ClinicalTrials.gov processed this record on May 07, 2009