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

April 18, 2008 updated by: Soroka University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Delivery Room, Soroka University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
perineal tears vs intact perineum
Time Frame: after delivery
after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
severity of perineal tears amount of suture material required for repair suturing length
Time Frame: after delivery
after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 21, 2008

Last Update Submitted That Met QC Criteria

April 18, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • sor468908ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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