The effect of Equisetum arvense (Horse tail) on perineal trauma in primiparous women with striae gravidarum

Determine the effect of Equisetum arvense (Horse tail) on perineal trauma in primiparous women with striae gravidarum

A Randomized clinical trial with a control group, parallel groups, triple blind

The present clinical trial will be performed on 60 pregnant women referred to obstetric clinic of Mashhad Omolbanin hospital. Sampling will be performed in convenience method and individuals who meet the inclusion criteria will be entered the study, then the research units will be randomly allocated into intervention and control groups based on the sequence created by a simple randomization online. Coding of medicinal and placebo creams is performed by the pharmacy consultant professor and by the end of the study, research units, the researcher, the statistical analyzer and delivery agent will not know the codes of Equisetum arvense and placebo cream.

Inclusion criteria: primiparous women, 18 to 35 years, gestational age 37 to 38 weeks, Total striae score higher than 9 (Moderate to Severe Striae), Body mass index 18.5 to 30; Exclusion criteria: medical and obstetric problems, vaginal infection, previous vaginal or perineal surgery, vegetarian diet, perineal massage

individuals in the intervention group will use Equisetum arvense cream (3%) from the 37-38 week of gestation until delivery, once a night before sleeping, and in the placebo group will use moisturizing cream (both creams are made in Pharmacological research center of medicinal plants in Mashhad university of medical sciences) in the perineum and beginning part of vagina. Also at delivery time episiotomy will be performed according to national guidelines and the discretion of delivery agent in both groups if indicated.

Degree, length and depth of perineal laceration

Sampling is performed at the obstetric clinic of Omolbanin hospital in Convenience Sampling method based on inclusion and exclusion criteria. Research units are allocated into two intervention and control groups using simple randomization online, by the sequence created at www.graphpad.com/quickcalcs; The Equisetum arvense (horse tail) and placebo cream, prepared and packaged by a pharmacy advisor professor at the Pharmacological Research Center of Medicinal Plants of Mashhad University of Medical Sciences. the pharmacy advisor professor has assigned a code to each group(only the Pharmacy Advisor professor knows it). Based on the A and B codes assigned to the two groups, the sequence is exemplified AABAB... . In order to allocation concealment, opaque, sealed and in sequentially numbered envelopes will be used that are kept by the secretary of obstetric clinic.

In order to blinding, the Equisetum arvense (horse tail) and placebo cream are provided to the researcher in similar shapes and identical tubes. Each tube has a code that only the pharmacy consultant professor knows about it. Individuals with inclusion criteria are grouped into intervention and control groups according to the sequence based on the codes; and by the end of the study, research units, the researcher, the statistical analyzer and delivery agent will not know about the codes of Equisetum arvense and placebo cream.