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

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ClinicalTrials.gov Identifier: NCT00662974
Recruitment Status : Unknown
Verified March 2008 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 21, 2008
Last Update Posted : April 21, 2008
Sponsor:
Information provided by:
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.

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

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



Primary Outcome Measures :
  1. perineal tears vs intact perineum [ Time Frame: after delivery ]

Secondary Outcome Measures :
  1. severity of perineal tears amount of suture material required for repair suturing length [ Time Frame: after delivery ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662974


Contacts
Contact: AVI HARLEV, MD 972-50-7434215 harlev@bgu.ac.il

Locations
Israel
Delivery Room, Soroka University Medical Center Not yet recruiting
Beer Sheva, Israel
Contact: EYAL SHEINER    972-54-8045074    sheiner@bgu.ac.il   
Sub-Investigator: EYAL SHEINER, MD PhD         
Sponsors and Collaborators
Soroka University Medical Center

Responsible Party: Avi Harlev, MD, OBGYN A DEPARTMENT, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00662974     History of Changes
Other Study ID Numbers: sor468908ctil
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: April 21, 2008
Last Verified: March 2008