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IRCT20230226057540N1 IRCT 2023-05-27 Rafsanjan University of Medical Sciences Evaluation the effect of perineal massage with sweet almond oil in late pregnancy on perineal trauma Evaluation the effect of perineal massage with sweet almond oil in late pregnancy on perineal trauma in pregnant women 2023-03-10 anticipated 120 Complete https://irct.ir/trial/68968 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Women eligible to enter the study will be divided into 3 groups of 40 people based on randomization by the CREATE A RANDOMISATION LIST program, using random blocks of size 6. The output of the software will be random letters (c, b, a) and each letter belongs to one of the intervention and control groups with the same probability 2 times in each block. In this study, 20 blocks of 6 are used, the first 6 people will be placed in three groups completely randomly (allocation of 2 people to each of the groups), then the next 6 people will be studied in three groups in the same way. The method will continue until the 6th person. The program CREATE A RANDOMISATION LIST can be retrieved on the Internet at https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: Sweet almond oil and paraffin prepared in Barij Esans Company are distributed to mothers in similar jars marked with code A and B. The midwife responsible for the delivery does not know the type of massage oil in the groups. The statistical consultant who is in charge of data analysis is not aware of the type of oil in groups A and B. N/A The state of perineal trauma. Intervention 1: Intervention group: Perineum massage with 1 cc of sweet almond oil will be performed daily for 10 minutes from the 34th week of pregnancy until delivery. Bottles of sweet almond oil and paraffin will be prepared by Barij Esans Company in similar packages that are marked with a code. Intervention 2: Intervention group: Perineum massage with 1 cc of parafin oil will be performed daily for 10 minutes from the 34th week of pregnancy until delivery. Intervention 3: Control group: No intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Maryam Mohseni khalilabadi
No.9, Alley 7, Pezeshk Ave., DehghanRajabi 3 st. Emam Ali Blvd
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3428 9767 mohseni_2007@yahoo.com Rafsanjan University of Medical Sciences scientific Maryam Mohseni khalilabadi
No.9, Alley 7, Pezeshk Ave., DehghanRajabi 3 st. Emam Ali Blvd
Rafsanjan Iran (Islamic Republic of) 7717936903 +98 34 3428 9767 mohseni_2007@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) pregnancy Iranian nationality 18 years 35 years Female Multiple births women aged less than 18 and more than 35 years Gestational age more than 35 weeks Malpresentation and Malposition Unwillingness to have a vaginal birth History of cesarean section Estimated fetal weight is less than 2500 and more than 4000 g Prevention N/A N/A Intervention group: Perineum massage with 1 cc of sweet almond oil will be performed daily for 10 minutes from the 34th week of pregnancy until delivery. Bottles of sweet almond oil and paraffin will be prepared by Barij Esans Company in similar packages that are marked with a code. Intervention group: Perineum massage with 1 cc of parafin oil will be performed daily for 10 minutes from the 34th week of pregnancy until delivery. Control group: No intervention Perineal trauma. Timepoint: during childbirth. Method of measurement: check list. Episiotomy. Timepoint: during childbirth. Method of measurement: check list. Apgar score. Timepoint: After childbirth. Method of measurement: Number. The length of the first stage of labor. Timepoint: during childbirth. Method of measurement: Number of hours. The length of the second stage of labor. Timepoint: during childbirth. Method of measurement: Number of hours. Rafsanjan University of Medical Sciences Approved 2023-02-18 Ethics Committee of Rafsanjan University of Medical Sciences Department of Midwifery, Faculty of Nursing and Midwifery , Nurse st. Rafsanjan Kerman Iran (Islamic Republic of)