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

S

Soroka University Medical Center

Status

Unknown

Conditions

Second Stage of Labor

Treatments

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

Funder types

Other

Identifiers

NCT00662974
sor468908ctil

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 2 patient groups

A
Experimental group
Description:
parturients during the second stage of labor massaged by Wheat Germ Oil
Treatment:
Other: perineal massage with Wheat Germ Oil during the second stage of labor
B
Experimental group
Description:
parturients during the second stage of labor massaged by almond oil
Treatment:
Other: perineal massage with almond oil during the second stage of labor

Trial contacts and locations

1

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Central trial contact

AVI HARLEV, MD

Data sourced from clinicaltrials.gov

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