Vaginal Tearing Clinical Trial
Official title:
Randomised ,Open Label in Meir Medical Center. Study the Potential of Dianatal Gel to Reduce the Rate of Episiotomy and Vaginal Tears in Birth
The purpose of the study is to see whether the use of DIANATAL during active labor, reduces the rates of episiotomy and vaginal tears.
The risk for vaginal tears during birth is about 20%. These tears require surgical repair,
are painful and make the recovery of the mother more difficult. Less commonly there is a
risk of tear infection and regional scarring that make intercourse more difficult. Moreover,
according to some studies, it appears that there is a link between damage to the pelvic
floor and vagina during labor and Urinary incontinence in stress later in life.
It is clear that there is an advantage for the prevention of vaginal tears. Dianatal is a
gel preparation, designed for use in births, in order to reduce the rate of vaginal tears
and possibly shorten the second stage of labor.
Tested and found that using the gel reduces friction on tissue in processes simulating
pressure of birth and therefore it is less likely to see tears in the vaginal tissue when
using gel.
The product is approved for use by the ministry of health, was safety approved by regulatory
bodies in Switzerland - the country of production.
So far, there is only one study published in the professional literature. The study found
that using the gel at birth, reduces the duration of the second stage (full opening to the
birth of the fetus) and reduces the rate of tears. The aim of the work was to investigate
the effect of the product on the duration of labor. Women on their first birth, were divided
randomly into two groups, one was treated with Dianatal from the stage of active labor, and
the other group did not receive any treatment. In each research group were about ninety
women. This is the single research in one population. In addition, the research group is too
small to have statistical power in order to answer issues related to the number of vaginal
tears and the need to perform episiotomies.
Considering such a significant issue for a woman who is giving birth and for the medical
staff dealing with the newborn and in light of the minority research information on this
subject, it is clear that there is room for further research.
Women who meet the inclusion criteria will be recruit to the research when arriving in the
delivery room. They will sign the consent form and will be computerized randomized to one of
two groups:
The study group - using DIANATAL according to manufacturer's protocol from their being in
active labor.
The control group - women with the same conditions that will not be using this medicine that
is checked.
The following data will be collected: medical background, pregnancy complications,
preparations that were used to reduce the risk of birth tears before birth (perineal
massage, EPINO), the duration of the stages in labor, use of epidural, neonatal weight,
whether episiotomy or vaginal tears that required surgical intervention ( sewing) were done,
post delivery process.
A comparison between the two groups will be made respectively with the results of the study
that were defined.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment