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IRCT20200224046605N1 IRCT 2020-04-10 Mashhad University of Medical Sciences The effect of Equisetum arvense (Horse tail) on perineal trauma The effect of Equisetum arvense (Horse tail) on perineal trauma in primiparous women with striae gravidarum 2020-05-20 anticipated 60 Complete https://irct.ir/trial/46151 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Perineal laceration during delivery. Intervention 1: Intervention group: Individuals in intervention group will apply a knuckle of equisetum arvense cream 3%(which is made in Pharmacological Research Center of Medicinal Plants of Mashhad University of Medical Sciences) in the perineum and the beginning part of vagina by the thumb and forefinger with a reciprocal movement,once at night before sleeping, from the beginning of 37-38 weeks of gestation. This group will receive routine midwifery care until delivery; episiotomy will be performed at delivery time, if indicated, on the discretion of the delivery agent. Intervention 2: Control group: Individuals in control group will apply a knuckle of cold cream (moisturizing cream, which is made in Pharmacological Research Center of Medicinal Plants of Mashhad University of Medical Sciences) in the perineum and the beginning part of vagina by the thumb and forefinger with a reciprocal movement,once at night before sleeping, from the beginning of 37-38 weeks of gestation. This group will receive routine midwifery care until delivery; episiotomy will be performed at delivery time, if indicated, on the discretion of the delivery agent. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Fatemeh Khademolkhamseh
Mashhad College of nursing and midwifery, Ibn Sina Ave., Doctora intersection, Daneshgah Ave.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Khademkf971@mums.ac.ir Mashhad University of Medical Sciences scientific Samira Ebrahimzadeh Zagami
Mashhad College of nursing and midwifery, Ibn Sina Ave., Doctora intersection, Daneshgah Ave.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 EbrahimzadehZS@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) primiparous women 18 to 35 years gestational age 37 to 38 weeks informed consent to participate in the study Iranian nationality living in Mashhad literacy for reading and writing single pregnancy cephalic presentation Total striae score higher than 9 (Moderate to Severe Striae) Body mass index 18.5 to 30 having Desire To give birth at Omolbanin Hospital 18 years 35 years Female medical and obstetric problems vaginal infection previous vaginal or perineal surgery drug or alcohol abuse vegetarian diet perineal massage having a history of allergy to herbal medicines O70 Perineal laceration during delivery Prevention Placebo Intervention group: Individuals in intervention group will apply a knuckle of equisetum arvense cream 3%(which is made in Pharmacological Research Center of Medicinal Plants of Mashhad University of Medical Sciences) in the perineum and the beginning part of vagina by the thumb and forefinger with a reciprocal movement,once at night before sleeping, from the beginning of 37-38 weeks of gestation. This group will receive routine midwifery care until delivery; episiotomy will be performed at delivery time, if indicated, on the discretion of the delivery agent. Control group: Individuals in control group will apply a knuckle of cold cream (moisturizing cream, which is made in Pharmacological Research Center of Medicinal Plants of Mashhad University of Medical Sciences) in the perineum and the beginning part of vagina by the thumb and forefinger with a reciprocal movement,once at night before sleeping, from the beginning of 37-38 weeks of gestation. This group will receive routine midwifery care until delivery; episiotomy will be performed at delivery time, if indicated, on the discretion of the delivery agent. Perineal laceration degree. Timepoint: Immediately after delivery. Method of measurement: Observation. Perineal laceration length. Timepoint: Immediately after delivery. Method of measurement: Measuring with sterile swap and ruler. Perineal laceration depth. Timepoint: Immediately after delivery. Method of measurement: Measuring with sterile swap and ruler. Mashhad University of Medical Sciences Approved 2020-01-27 Ethics committee of Mashhad University of Medical Sciences Assistance of Research and Technology of Mashhad University of Medical Sciences, Qurashi building, Daneshgah avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)