NCT00662974

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 21, 2008

Status Verified

March 1, 2008

Enrollment Period

7 months

First QC Date

April 17, 2008

Last Update Submit

April 18, 2008

Conditions

Second Stage of Labor

Outcome Measures

Primary Outcomes (1)

  • perineal tears vs intact perineum

    after delivery

Secondary Outcomes (1)

  • severity of perineal tears amount of suture material required for repair suturing length

    after delivery

Study Arms (2)

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

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

Interventions

perineal massage with Wheat Germ Oil during the second stage of laborOTHER

30 ml of oil applied during labor

A
perineal massage with almond oil during the second stage of laborOTHER

30 ml of oil applied during labor

B

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton pregnancy
  • Term pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delivery Room, Soroka University Medical Center

Beersheba, Israel

Location

Central Study Contacts

AVI HARLEV, MD

CONTACT

972-50-7434215harlev@bgu.ac.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 21, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

April 21, 2008

Record last verified: 2008-03

Locations

IL(1)