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IRCT20180926041143N1 IRCT 2019-01-02 Mashhad University of Medical Sciences The effect of topically-applied combined herbal cream on Striae gravidarum in nulligravida women The effect of topically-applied combined herbal cream on prevention of Striae gravidarum in nulligravida women 2018-10-06 anticipated 140 Complete https://irct.ir/trial/34071 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be based on simple randomization. The method used to randomize will be a random number table. To hide random assignments, numbered drug containers with random number sequences will be used, Blinding description: For the primary blindness of the study, since the possibility of sampling is different between the two groups, pregnant women have no knowledge of the contents of the cans in the other group. The second stage of blinding is that the researcher's assistance in the field of training and delivery of cans does not have the information on the type of the groups and the contents of the cans, and only records the cans in the sample form when the code is delivered. The next steps are to get the worm by the manufacturer to fit the group that belongs to him. The final stage of blindness is in relation to the individual who will analyze the results. She is also unaware of the groups and intervention. The research team leader will only decode the codes after analyzing the results. 3 Steriae Gravidarum. Intervention 1: Intervention group: Herbal cream consisting of Calendula, Chamomile, Geranium, Cocoa and soybean seeds on pregnancy stretch from 14-16 weeks of gestation in primiparous women, twice daily by 0.3 grams or a half teaspoon in all four areas From the body, including 1. Separate the umbilicus to the symphysis pubis 2. Immediately above the umbilical in the transverse direction, 3. The right side in the longitudinal direction, 4. The left side, in the longitudinal direction, and massage gently, until the end of pregnancy. This herbal cream is made by Tus Amithis Ariaia company, under the supervision of the Center for the Growth of the Buali Institute in Mashhad. Intervention 2: Control group: Placebo cream consisting of Calendula, Chamomile, Geranium, Cocoa and soybean seeds on pregnancy stretch from 14-16 weeks of gestation in primiparous women, twice daily by 0.3 grams or a half teaspoon in all four areas From the body, including 1. Separate the umbilicus to the symphysis pubis 2. Immediately above the umbilical in the transverse direction, 3. The right side in the longitudinal direction, 4. The left side, in the longitudinal direction, and massage gently, until the end of pregnancy. This herbal cream is made by Tus Amithis Ariaia company, under the supervision of the Center for the Growth of the Buali Institute in Mashhad. No - There is not a plan to make this available Justification or reason for not sharing IPD is So far, there is no definite program and protocol in Mashhad University of medical sciences.
public Somayeh Alirezaei
Department of Midwifery, School of Nursing & Midwifery, Mashhad University of Medical Sciences, Ebn Sine St, Daneshgah Ave, Mashhad Town
Mashhad Iran (Islamic Republic of) 38528512 +98 51 3852 8512 Alirezaeis961@mums.ac.ir Mashhad University of Medical Sciences scientific Somayeh Alirezaei
Ebn Sina St, Daneshgah Ave
Mashhad Iran (Islamic Republic of) 9137913199 +98 51338591511 Alirezaeis961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Pregnant nullipara women Gestational Age range 14-16 week Age range 20-35 year BMI range 18.5-25 Kg/m2 No smoking Not having any chronic diseases (Cardiovascular, Hypertension, diabetes, ...) 20 years 35 years Female ster Prevention Prevention Intervention group: Herbal cream consisting of Calendula, Chamomile, Geranium, Cocoa and soybean seeds on pregnancy stretch from 14-16 weeks of gestation in primiparous women, twice daily by 0.3 grams or a half teaspoon in all four areas From the body, including 1. Separate the umbilicus to the symphysis pubis 2. Immediately above the umbilical in the transverse direction, 3. The right side in the longitudinal direction, 4. The left side, in the longitudinal direction, and massage gently, until the end of pregnancy. This herbal cream is made by Tus Amithis Ariaia company, under the supervision of the Center for the Growth of the Buali Institute in Mashhad. Control group: Placebo cream consisting of Calendula, Chamomile, Geranium, Cocoa and soybean seeds on pregnancy stretch from 14-16 weeks of gestation in primiparous women, twice daily by 0.3 grams or a half teaspoon in all four areas From the body, including 1. Separate the umbilicus to the symphysis pubis 2. Immediately above the umbilical in the transverse direction, 3. The right side in the longitudinal direction, 4. The left side, in the longitudinal direction, and massage gently, until the end of pregnancy. This herbal cream is made by Tus Amithis Ariaia company, under the supervision of the Center for the Growth of the Buali Institute in Mashhad. The number, Severity and Size of Steriae Geravidarum based on Atwal Scoring. Timepoint: Evaluation of Steriae Gravidarum at 27-30 and 38-40 of Gestational Age. Method of measurement: The numerical scoring system of Atwal. Mashhad University of Medical Sciences Approved 2018-10-03 Ethic committe of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Num 18, Daneshgah Ave, Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)