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

NCT ID: NCT00662974

Last Updated: 2008-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Second Stage of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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A

parturients during the second stage of labor massaged by Wheat Germ Oil

Group Type EXPERIMENTAL

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

Intervention Type OTHER

30 ml of oil applied during labor

B

parturients during the second stage of labor massaged by almond oil

Group Type EXPERIMENTAL

perineal massage with almond oil during the second stage of labor

Intervention Type OTHER

30 ml of oil applied during labor

Interventions

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

30 ml of oil applied during labor

Intervention Type OTHER

perineal massage with almond oil during the second stage of labor

30 ml of oil applied during labor

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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OBGYN A DEPARTMENT, Soroka University Medical Center

Locations

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Delivery Room, Soroka University Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Central Contacts

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AVI HARLEV, MD

Role: CONTACT

Phone: 972-50-7434215

Email: [email protected]

Facility Contacts

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EYAL SHEINER

Role: primary

Other Identifiers

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sor468908ctil

Identifier Type: -

Identifier Source: org_study_id