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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00662974
First received: April 17, 2008
Last updated: April 18, 2008
Last verified: March 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
  More Information

No publications provided

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

ClinicalTrials.gov processed this record on July 29, 2014